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Department Overview:

Channel Operations’ mission is to ensure that the right product gets to the right place at the right time.

Key Responsibilities:

• Provide outstanding customer service to all internal and external customers, partners and other stakeholders.

• Acts as the first-line of contact for external channel customers or other related external parties, assisting with all GNE product order and related requests.

• Provides full-time telephone coverage, customer call handling.  Receives and manages high-volume telephone calls/inquiries as well as departmental faxes or other communication methods.

• Manages Genentech’s carriers to ensure shipments are delivered on-time and addresses/escalates as appropriate.

• Processes returns and invoice adjustments for various customer segments in addition to creating and issuing RA’s (Return Authorizations) and fulfilling damaged replacement order requests

• Validates state licenses for all customers to ensure PDMA (Prescription Drug Marketing Act) compliance, creates, updates and issues licenses as appropriate

• Supports Senior team in the processing of the Spoilage program, research and processes all returns including recalls.

• Ensures final system approval is complete for time sensitive Corporate DOPs.

• Represent the group on cross-functional teams as needed.  

• Processes all external customer product orders, for the entire Customer Service Portfolio team including Lucentis Direct, which could include Tamiflu order processing during flu season.

The successful candidate will demonstrate key competencies listed below critical to this role:

• Decision Making – Thinks through problems clearly and logically; is decisive

• Technical and Business Expertise – Applies emerging knowledge and trend; builds strong relationships; contributes expertise within and beyond assigned area

• Communication -  Listens well, expresses ideas fluently and logically, is open to input and feedback

• Teamwork and Collaboration – Creates an atmosphere of openness and trust; collaborates, offers support and encouragement

• Achieving Results – Is goal-directed and persistent; is accountable for meeting commitments, recognizes the contributions of peers

Customer Service Specialist, Portfolio

Qualifications:

The following qualifications, experience and criteria unless otherwise stated as “preferred” or “a plus” are required:

• BA/BS or 3 years call center/customer service experience is preferred

• 2 or more years related work experience, i.e., customer service, administration-preferably gained within the pharmaceutical, biotechnology or related industry

• Must demonstrate knowledge of data entry and good basic computer skills, e.g., proficiency with Microsoft Word, PowerPoint, Access, etc.

• Previous database/computer systems experience, particularly in a high-volume, customer service/call center environment is strongly preferred

• ERP (Enterprise Resource Planning) systems experience, particularly SAP, is preferred

• Technical expertise and Microsoft Excel experience preferred, comfortable with both informal and formal UAT (user acceptance testing) strongly preferred

• Strong analytical and business mathematics skills required.

• Good time management, organizational skills including both good written and verbal communication skills.

• Ability, comfort & commitment to operate in a highly regulated environment and industry that requires a fundamental understanding of adherence to company policies, procedures and relevant internal or external laws and regulations

• Positive proactive attitude, strategic agility and a mindset of continuous improvement

• Must have the ability to operate in a multitasking environment and within strict timelines.

• Must be action oriented with a high degree of initiative and leadership.

• Must be resourceful with excellent organization and customer service skills.

• Proven ability to effectively exercise judgment and discretion with confidential and sensitive information

While we will interview the strongest applicants for this role, we will prioritize CCM candidates who have been displaced from their current roles due to organizational restructuring.

Summary:

The Implementation Manager is responsible for leading all aspects of an implementation.  Drives a team of developers and quality assurance engineers who are responsible for the successful development, scheduling, verification, validation, and performance of a product installation. Ensures adherence to customer and contract requirements and company policies, procedures and guidelines. Collaborates with stakeholders both locally and globally. Leads an implementation team in a global organization.

What you do:

Responsibilities include, but are not limited to:

?     Drive all implementation activities to a successful go live

?     Support successful transitioning from the sales to the implementation process

?     Ensure there are clear project deliverables and success criteria between Roche and the customer that are validated at the end of each implementation

?     Develop the initial statement of work to be included in the contract and finalize with customer during implementation kick-off

?     Work with the implementation team to complete the delivery at the committed time

?     Identify and track project action items, issues, impediments and risks and drive to resolution

?     Identify service requirements to be aligned with product management and RnD

?     Provide regular project status reports both internally and to the customer(s)

?     Work with internal teams to collect information for resource forecasting and to support sales slotting. Participate in the Implementation Council and ensure all key information has been collected prior to discussion

More general responsibilities are

?     Develop and/or enhance streamlined processes for implementation management

?     Continuously drives and improves implementation best practices and internal deliverables

?     Provide strategy to define, enhance, and grow the PM processes within Roche

?     Set up and run project touch base and status meetings

?     Support PM tools, such as Jira and Confluence, and integration of project information to/from other tools such as Zendesk and Salesforce. Develop and report on project KPIs.

Who you are:

• Bachelor’s degree, preferably in business administration, IT or a technical discipline.
• Minimum 5 years of related experience.
• Superior project and time management skills; excellent attention to detail
• Deep understanding of software and laboratory operations in one or more of the following roles: project management, laboratory solution implementation and custom projects
• Proven track record of customer interaction and managing stakeholders at all levels

Preferred:

• Technical background in IT products, data analytics, and lab workflow knowledge
• Solid knowledge of healthcare and experience interacting with Hospital Information Systems

#LI-ND1

Overview

About the Transformation Team

The Transformation Team was established by the Genentech US Commercial, Medical Affairs, Government Affairs (CMG) Leadership Team (USLT) to catalyze and support the CMG journey to become a more agile, customer-centric organization where employees have a meaningful impact on patients every day. The Transformation Team is comprised of leaders from various CMG functions and works in partnership with US LT, CMG leaders and employees to catalyze a transformative mindset and co-create and integrate a new operating model.

About the Coaching Community of Practice

Embedding coaching capabilities in CMG is a high priority for USLT due to its potential to accelerate transformation across CMG. Our coaching community of practice (known as “Coachella”) is a vibrant community of selfless and brave coaches who inspire others to be the change. This community is a delivery arm of the Transformation Team because it is responsible for bringing to life mindset shifts and ways of working with teams and leadership. The community is currently comprised of 12 expert coaches as well as coaches-in-training on 6-12 month rotations, and is expected to increase to 20 coaches by Q1 2019 and have an additional 10-15 coaches-in-training at any one time. The community also provides teaching and coaching support to champions at team level who facilitate day to day team activities.

About the role

The Coaching Head is a role of critical strategic importance to transformation. This role is accountable to the USLT for providing coaching support and for bringing to life the mindset shifts and new ways of working across CMG.

The leader in this role will be called upon to combine expert strategic change leadership, strong business acumen, and ability to build and operationalize a function.   S/he will manage a team of 10-15 full time employees and contractors, and another 10-15 employees on rotations of 6-12 months.

This role is the work product owner of coaching at CMG, and is responsible for setting the vision and strategy for coaching delivery, significantly scaling up and and building the coaching operating model, establishing and staffing the coaching (“Coachella”) team.  This role is also responsible for assessing and prioritizing coaching needs and support across CMG.

This role is a member of the Transformation Team, and works in close partnership with the Enterprise Coach to deliver on the coaching vision and transformation priorities.

Key responsibilities:

• Visionary:  has full strategic responsibility for building coaching capabilities and support for CMG as a whole; defines the vision, strategy and objectives for coaching delivery for 1-2 year horizon based on regular assessment of team and leadership coaching needs; is a scholar of organizational theories and practices, works at the bleeding edge of innovation in organization effectiveness and is a thought leader in this field; is accountable to achieve the vision and defined objectives  

• Architect: designs, continuously adapts and deploys the coaching support model to meet business, transformation, team and leadership needs; attracts and retains Coachella talent; orchestrates the continual upgrade of nWOW over time in collaboration with transformation team and Coachella.

• Catalyst: prioritizes coaching needs and decides where to deploy coaching resources across CMG functions and teams based on business impact and transformation priorities; provides sensing information on ecosystem health based on Coachella activities and helps transformation team define and implement its change roadmap

• Coach:  serves as prime internal and external contact and subject matter expert to senior executives and other leadership across the Roche group on how to build and scale coaching capabilities for strategic transformation initiatives; diagnoses coaching needs of teams and leadership; helps teams and leaders self-assess their needs for coaching and support in adopting nWOW and advises them on available coaching options, timing and the pre-conditions that lead to successful coached experiences; inspires CMG to adopt new mindset and nWOW  

• People Management - manages a team of 10-15 full time employees and contractors, and another 10-15 employees on rotations of 6-12 months

The successful candidate will demonstrate the following capabilities critical to this role:

• Strategic agility – Balances what will pay off in the short-term while articulating wise, long-term objectives and strategies.   Leverages internal and external information and relationships to advise senior leaders about the direction of the organization.   Can apply systems thinking and take into consideration implications of change for the entire Genentech ecosystem

• Decision making - able to prioritize coaching needs based on business impact and potential to accelerate transformation, Embedding coaching capabilities in CMG is a high priority for USLT due to its potential to accelerate transformation.

• Teamwork and collaboration – Is able to pull people together around a common goal, and brings an enterprise perspective.    Effectively manages relationships with all business partners, establishes trust and credibility quickly with particularly senior leaders. Strengthens and extends existing relationships to maintain a holistic view of the organization. Proactively assesses health of working relationships amongst the team and quality of work product and shares feedback to course correct.

• Entrepreneurial – Can effectively synthesize insights to understand the needs and priorities of the organization.  Sees and seizes opportunities to improve internal processes or approaches to ensure Genentech’s long-term success. Creative, out of the box thinker and designer, translating concepts and frameworks into tangible business solutions.  

• Inspiring and influencing – Is inspirational and skilled at managing teams, peers and upwards.  Effectively navigates the organization, understanding and accounting for varied priorities and perspective of different internal stakeholders.  Applies a blended EQ/IQ approach, integrating both business and organizational aspects to drive adoption of change.

• Feedback and coaching – Develops people through constructive feedback and encouragement; encourages appropriate risk-taking to develop individuals through challenging stretch assignments. Coaches senior leaders on effective sponsorship and behaviors to embed organizational change.

You are a person with the following qualifications and experience: unless stated as "preferred" or "a plus," all other criteria are required:

• Bachelors Degree in Science or Social Sciences

• Experience leading large scale change initiatives

• Experience applying the new ways of working, with successes and failures

• Agile coaching or scrum master certification is a plus

• Passion and hands on experience in experimentation, innovation and learning

• Robust understanding of the pharma/biotech/or related industry, Genentech's overall business model

• Comfortable leading without authority, ambiguity, and ability to adapt to change and quickly shifting priorities

• Ability, to operate in a highly complex environment, which requires understanding of the imperative for compliance with company policies, procedures and other relevant internal or external laws, regulations and the like

Job Responsibilities

• Development, analysis, execution, and optimization of:

  • ALCM processes supporting every phase of the asset lifecycle, from project initiation to asset decommissioning and retirement.

  • Reliability-centered maintenance, design and spares programs.

  • Analysis and reporting of equipment performance metrics and trends; identification and prioritization of asset improvement initiatives.

  • Predictive and condition based maintenance and monitoring programs, including lubrication, vibration, thermography, motor circuit analysis, eddy current, ultrasound, and corrosion trending.

  • Execution of failure and root cause analyses to identify failure modes and causes.

  • Identification, development, and implementation of industry and network best practices.

• Reliability engineering support of expense/capital projects to ensure equipment design meets reliability and maintenance requirements.

• Approval of project documentation and assessment/approval of Change Control records.

• Comply with Pharmaceutical Quality System and company engineering standards and requirements.

• Provide reliability engineering subject matter expertise to Technology, Manufacturing, Quality, and Facilities & Engineering organizations as needed, for example, in complex investigations and CAPAs.

• Collaboration with peers in the continuous improvement of technical infrastructure, including standards, practices, specifications, procedures and business processes.

• Development and/or approval of controlled documents impacting Reliability Engineering.

Job Requirements

• BS in Chemical, Mechanical, Industrial or other Engineering discipline plus 3-5 years of relevant experience in pharmaceuticals, nuclear power, oil and gas, or other heavy industry.  Familiarity with cGMPs preferred.

• Demonstrated ability to develop actionable insight from data, influence decision makers, and drive initiatives to completion. Strong proficiency in mathematics, especially statistics.

• Exceptional collaboration, communication and interpersonal skills.  Demonstrated ability to work in cross-functional, matrixed teams (e.g., engineering, operations, maintenance, quality, etc.) to deliver impactful results.

• Strong proficiency with MS Office and Google Suite products, especially Excel/Sheets.  Familiarity with SAP (R/3 and BW), Tableau, SQL or other data analysis, reporting and visualization tools a plus.

• Familiarity with reliability engineering principles and techniques preferred.  Project management, maintenance management, or lean six sigma expertise a plus.

Genentech’s South San Francisco Production (SSFP) group manufactures medicines that improve the lives of patients around the world.  SSFP is the first cGMP production site established by Genentech and includes facilities, equipment, and staffing to perform end-to-end manufacturing that is scheduled and supported 24 x 7.

SSFP currently has opportunities available for experienced Utility Operators to join the day shift. These positions operate utility systems and subsystems in an FDA regulated environment to ensure:

• All preventative maintenance is performed in a timely manner and at appropriate intervals
• Equipment remains in its designed cGMP and/or validated state at all times
• All equipment operation is in accordance with federal, state, local and company regulations, procedures and policies

Responsibilities include:

• Manage the day to day operation of plant utility systems; monitor the overall operation and status of the utility systems and submit work notifications for system repairs as needed
• Ensure/maintain all utility equipment areas in a constant state of inspection readiness
• Continuously evaluate the operation of all utility systems and utility subsystems; identify specific process improvement needs and provide recommendations for system upgrades
• Identify training deficiencies, provide recommendations for training and provide training as needed
• Continuously evaluate all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability
• Provide operational support to Facility Services, Engineering, Manufacturing, and Research and Development
• Perform Confined Space Entry on an as needed basis
• Complete preventive maintenance and assigned paperwork in a timely manner following all cGMP documentation guidelines
• Gather and document appropriate information associated with a System Discrepancy (an event in manufacturing process and/or support system that is outside approved operating parameters or approved procedures)
• Work with various chemicals, steam, pressurized gases/liquids of various temperatures
• Work in close proximity to moving equipment
• Act as point of contact for customer guidance and support
• Ensure all Utility rounds are completed and missed rounds are documented
• Monitor Utility work request queue and advancing notifications into work orders
• Assist in troubleshooting efforts for all Utility equipment that is directly impacting manufacturing processes
• Attend all required cGMP and Safety training

We are seeking local applicants who possess the following qualifications. The level of the position will depend on the qualifications of the selected candidate.

• High School diploma or equivalent. Technical degree, certificate, or coursework a plus
• 3+ years of experience in an industrial / manufacturing maintenance role with demonstrated strong mechanical aptitude; 7+ years required for the Specialist level
• Completion of technical school, accredited 2 year program or applicable work history (OJT) in the field
• Practical knowledge of equipment maintenance, operation, control and cleaning for: process equipment; HVAC/R; clean utility systems; process air systems; waste neutralization systems; bulk chemical and gas systems; RW/Glycol Systems
• General knowledge of shop tool operation and safety
• Ability to respond to and evaluate a variety of situations involving mechanical, electrical and systems controls
• Practical knowledge of equipment maintenance, operation, control and cleaning for process equipment; HVAC/R; clean utility systems; process air systems; waste neutralization systems; bulk chemical and gas systems; RW/Glycol Systems is required for the Specialist level
• Working knowledge of electrical switchgear and distribution systems in the medium to low voltage range is also required for the Specialist level
• Ability to perform preventive maintenance and equipment servicing according to Standard Operating Procedures
• Effective verbal and written communication skills including the ability to prepare technical reports and the ability to read and understand Standard Operating Procedures (SOPs)
• Detail oriented with the ability to demonstrate good record keeping practices
• Ability to understand and adhere to federal, state, local and company regulations, procedures, and policies
• Computer skills with the ability to use word processing, spreadsheet, database, and email applications
• Ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery
• Strong interpersonal skills with the ability to work effectively as part of a team
• Ability to work with minimum or no supervision.
• Ability to work a regular shift that includes one weekend day, and flexibility to work overtime or a temporarily modified shift schedule to support manufacturing operations as needed

#LI-PTD-JM

Relocation is not designated for this position.

The Senior Biosample Lab Associate (Sr. BLA) is responsible for the assignment, coordination, and execution of activities related to the tracking, inventory, sample processing, and transport of biological samples for clinical and non-clinical trials.  The Sr. BLA serves as a system, instrument or workflow Subject Matter Expert and works under supervision and minor guidance of the Lab Head or Biosample Operations Lab Supervisor to ensure that lab activities fulfill customer needs while achieving operational excellence in quality, service level, cost and compliance. The Sr. BLA provides guidance and help to BLAs and may deputise for the Lab Head or Biosample Operations Lab Supervisor, for daily functional activities, excluding line management responsibilities.

Primary Responsibilities and Accountabilities:

• Responsible for assigning, coordinating, and executing tasks to ensure timely completion of all relevant operational activities
• Responsible for coordinating and conducting manual and/or automated sample aliquoting for various sample types, e.g. serum/plasma/urine/DNA/RNA
• Responsible for coordinating and conducting DNA/RNA extraction activities from various clinical sample types (Blood, Tissues, WBCs, plasma, saliva, urine)
• Responsible for coordinating and conducting in-process QC methods to assess quality of samples
• Responsible for the evaluation of novel technologies and techniques for their suitability for analysing clinical samples 
• Responsible for conducting experiments that address critical findings from analytical data anomalies that are potentially sample-related; participates in interpretation of results and authorship of final reports
• Responsible for authoring or updating local and global controlled documents in collaboration with the Compliance team
• Responsible for providing BOLS and/or Lab Head with regular input on operational issues and practices related to sample processing, sample handling and shipment tracking activities
• Responsible for process and instrument development and implementation at the local site level with direct supervision from the BOLS and Lab Head to enable BRM operations to meet the needs of researchers and clinical study teams
• Responsible for providing operational support in answering requests for forecasting, tracking and budgeting from the local Lab Head and the BOLS.
• Responsible for providing Lab Head and BOLS with regular input on health and safety issues
• Responsible LIMS, instrument or workflow Subject Matter Expert relating to associated operational lab procedures
• Responsible for sample handling activities, i.e. ensuring samples are received, accessioned, tracked, and stored in a timely manner and according to protocol requirements & BRM Operations best practices
• Responsible for following all applicable controlled documents (e.g. SOPs, Working instructions, and working documents for all relevant sample handling, storage, and sample processing activities, while adhering to appropriate GCP lab guidelines and local health & safety rules
• Responsible for the completion, filing, and archiving of all relevant study documentation according to the applicable controlled documents.
• Responsible for the communication and collaboration with Sample Information and Services in regards to sample requests and sample discrepancies so that high quality sample and associated data are provided to researchers.
• Responsible for maintaining tidy and organized working environment in laboratory work areas.
• Responsible for accurate freezer inventories
• Responsible for checking and replenishing of stocks for commonly used material for sample handling, sample shipping and sample processing, as appropriate.
• Responsible for freezer management activities (e.g. qualification, temperature monitoring, issue logs, maintenance, monitoring freezer space & organization)
• Responsible for setting up and preparing outbound shipping requests and related documents within agreed timelines and according to the applicable transport regulations.
• Responsible for the distribution of samples to internal lab and the tracking of confirmation of delivery for sample shipments to external analytical laboratories
• Responsible for the destruction of samples in accordance with applicable guidelines
• Responsible for importing processed samples into LIMS
• Responsible for supporting method development, qualification, and implementation of laboratory instruments
• Responsible for coordinating and conducting laboratory process optimization, proof-of-concept, and/or validation

Education / Qualifications:

Minimum: BS in science or equivalent recognized qualification and/or 4-5 years of experience in similar sample handling and processing laboratory environment.

Preferred: BS/MS with at least 5 years of hands-on experience in molecular biology techniques applied in a pharmaceutical/biotech company or academic labs

Experience, Skills, Knowledge

• Demonstrated experience working in a laboratory managing clinical or non-clinical samples and Subject Matter Expert in LIMS system, instrument or processing workflow.
• Demonstrated experience in molecular techniques such as DNA/RNA extraction, Picogreen & Ribogreen quantitation, PCR, RT-PCR
• Must have extensive knowledge and/or experience in Sample Collection, Storage, and Processing for various types of samples
• Demonstrated ability to positively influence peers and colleagues in regulated laboratory environment
• Must be able to proactively solve problems using logical troubleshooting as well as plan and execute activities to meet deadlines
• Critical reasoning skills including the identification and resolution of basic operational issues; exercises good judgement in decision making
• Experience assessing, tracking and fulfilling research customer needs on an operational level in an efficient and timely way with a high degree of customer orientation
• Awareness and appreciation of the ethical considerations for the use of biological samples
• Strong organizational, multitasking, and prioritization skills.
• Strong written and oral communication skills
• Requires attention to detail and accuracy in data entry while maintaining study timelines.
• Strong analytical and problem solving skills, paired with partnering and performance skills.
• Team player with strong interpersonal skills and the ability to build effective working relationships inside and outside their functional area with experience of working in multicultural teams
• Demonstrated ability working under pressure and to tight timelines
• Good level of initiative and the ability to work independently and to manage multiple competing priorities with minimal supervision
•  Proven accountability to assess needs and deliver to expectations
• Proven experience in leading projects, teams, and initiatives
• Prior experience in presenting to groups and individuals in any level
• Prior experience in prioritization and delegation of activities to others
• Proven critical thinking skills, including the identification and resolution of complex problems
• Experience in resolving issues as an escalation point
• Extensive experience in negotiation, conflict resolution and decision making
• Extensive experience in communication with Management, vendors, stakeholders and peers
• Prior experience in working virtually with distributed teams and individuals

 As a plus:

• Clinical or biological laboratory experience in a high-throughput, automated setting with responsibility for the efficient and timely processing and/or analysis of biological samples
• Strong theoretical and practical understanding of nucleic acid handling and analysis
• Prior experience with Micro Array, Whole Genome Sequencing, and DNA next generation sequencing (NGS)
• Experience in defining requirements and implementation of laboratory information management systems and data processing
• Familiarity with the biopharmaceutical drug development process and GLP/GCP experience

*LI-PD-BR1

Position Summary

Digital Customer Experience (DCX) is a functional group within Genentech Business Operations (GBO) comprised of experienced digital experts who partner across CMG to orchestrate and deliver integrated digital customer experiences that drive measurable business outcomes.

The purpose of this role is to be the subject matter expert and solution owner for paid digital media platforms within DCX. They will be responsible for understanding business and customer needs, identifying opportunities for automation and innovation, designing and implementing solutions that allow for scale and efficiency.

Key Responsibilities:

• Accountable for solution architecture and roadmap of media platform strategy
• Responsible for platform-as-a-service performance as measured by the enablement of business outcomes
• Responsible for proposing technology solutions and getting buy-in from functional leaders/squad leaders, securing investments and then leading teams to implement such solutions
• Define and manage solution architecture from idea to implementation ensuring that solution supports the business objectives, while maintaining the integrity of the overall enterprise architecture
• Provide technical leadership to team members and vendor resources (onsite and offshore). Manages platform/technology vendors, including contracting
• Proactively identify and determine solutions to execute business objectives
• Represent technical POV in cross-functional team meetings for defining new requirements or resolving business issues as needed.
• Maintain product technical knowledge and lead architecture design discussions
• Work with other platform leads and architects to design and implement high availability, high performance systems in support of strategic goals.
• Review the team’s work to ensure compliance to standards and best practices.
• Be an owner in defining and overseeing overall development/data governance and standards.
• Specialized knowledge in the AdTech practices and trends
• Leads and participates in cross CMG efforts requiring the integration of data and systems in order to drive business and customer outcomes
• Drives efficiency and improvements in media/social operations and strategy by advising/training on the effective use of platform/data

Skills and Competencies

• Ability to anticipate business needs, drive clarity in ambiguous situations and strong problem-solving skills
• Excellent planning and executional skills; ability to build strategies and plans that align with business priorities
• Strong system and data Integration skills, as it relates to digital marketing
• Solid large project management skills to ensure that all project deliverables are on time and high quality
• Strong Business Analysis skills, documenting and developing operational and governance processes
• Strong understanding of Cloud technologies
• Strong critical thinking and analytical skills
• Strong collaboration & communication skills
• Strong vendor and stakeholder management & negotiation skills
• Ability to forecast and manage resources for operations
• Ability to gauge the feasibility, impact and risks of proposed enhancements & innovations
• Ability, comfort & commitment in/to operating in a highly regulated environment and industry, which requires understanding of the imperative for compliance with company policies, procedures and other relevant internal or external laws and regulations

Qualifications

• Bachelor’s degree in Engineering or a related field
• MBA or other related graduate degree preferred

Experience

• Overall technology experience of 10 years
• 5+ years of related work experience, preferably in paid media, marketing operations, or advertising operations
• Advanced knowledge of campaign management, ad server and bid management platforms (Google/DoubleClick experience a plus)
• Experience managing paid search, display, and social advertising campaigns
• Google AdWords, Google Analytics, and/or Bing Ads certification (additional certifications are a plus)
• Knowledge of social media platforms and measurement tools
• Experience with data integrations using strong data management principles

#LI-<BU>KG1

The Associate Director (AD) of Clinical Operations will provide strategic direction and leadership to the assigned therapeutic area(s) (TA) and other bodies on the Clinical Operations aspect of the portfolio and programs, which may include Patient Engagement, Biosample Operations, Process and Systems. Additional accountabilities include the oversight and delivery of all Clinical Operations activities, concerning all programs within the assigned TA(s) for USMA.  

In this role, the AD of Clinical Operations will be a standing member of the USMA Evidence Generation Leadership Team and Medical Network Leadership Team(s) relevant to the assigned program responsibilities. The incumbent will also manage a team of direct reports, which may include Clinical Program & Study Leaders, Administrative Associates and contingent workforce employees.

All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.

Key Responsibilities/Accountabilities:  

Key Accountabilities:

In this position, you will be primarily accountable for consistently, effectively:

• Leading, managing and developing your direct reports

• Guiding and ensuring expert clinical operations input into relevant USMA Medical Plans to support USMA medical strategy execution and overall success across the assigned therapeutic area(s)

• Overseeing and guiding USMA clinical programs and associated clinical studies operations across the assigned therapeutic area(s), and assuming accountability for such, to ensure delivery of clinical operations activities to meet study plans outlined by medical plans.

• Providing direction and leadership to USMA Clinical Operations teams dedicated to assigned therapeutic area(s); includes ensuring appropriate CRO and other vendor oversight

• In partnership with Alliance and Advocacy Relations team in Government Affairs, develop and maintain relationships with Patient Thought Leaders to support patient engagement strategies and maintain a network of patient advocacy alliances (e.g. sites, networks, cooperative group partnerships) aligned with the needs of the current and emerging portfolio

• Ensuring USMA Clinical Operations teams and vendor partners deliver on commitment to agreed targets

• Ensuring study adherence to budget, ICH-GCP standards, Genentech/Roche Standard Operating Procedures (SOPs) and other operating guidelines and regulatory requirements

• Ensuring USMA Clinical Operations teams for the assigned therapeutic area(s) compliantly develop and cultivate productive relationships with external partners/stakeholders

• Ensuring that risk and quality plans are robust, proactive and implemented for all studies and related activities across the assigned therapeutic area(s)

• Driving study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement

• Driving clear decisions in the project team environment

• Ensuring the assigned USMA Clinical Operations team meets or exceeds assigned goals and objectives

• Aligning, motivating and inspiring your team to work in accordance with broader Roche, Genentech and Medical Affairs strategies and goals

Role Responsibilities:

People Management/Leadership:

• Hire, develop, and oversee the work of your direct reports

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer-term

• Act as part of the U.S. Medical Affairs (USMA) Clinical Operations Leadership Team and play a key role in cross-therapeutic planning and decision-making

• Develop/lead organizational design, resource requirements, compensation, expense budgets, as well as immediate, medium and long-term capacity for the assigned USMA Clinical Operations function and team

• Provide vision and strategic direction to your team

Therapeutic Area Management:

• Act as the primary interface to USMA senior management (Medical Unit Heads, Group Medical Directors) and Product Development Medical Affairs (PDMA) counterparts to ensure alignment and high performance of clinical trials in your therapeutic area(s) of responsibility

• Contribute functional expertise to the development of the therapeutic area (TA) strategy, both within the TA Medical Unit(s) and USMA Clinical Operations

• Ensure that the TA strategy is shared, supported and implemented within the Clinical Operations function and the TA

• Provide leadership and strategic guidance on the development and implementation of clinical trials including:

  • Delivery of program level activities to the TA from USMA Clinical Operations

  • Timely and accurate input into USMA plans, including forecasting of timelines, assessment of feasibility for protocol design, estimation of resources, and TA budget

  • Review and approval of the consolidated full-time equivalent (FTE) and program operational budgets for the TA

  • Identification of operational efficiencies across molecules within the TA

  • Identification of TA risks; proactively creating and implementing mitigation strategies.

  • Oversight of USMA Clinical Program Leaders/Study Management Teams (SMTs) with leadership and assistance in issue resolution ensuring SMT success.

• Provide oversight to USMA Clinical Operations teams in vendor review, selection and issue escalation management

• Effectively collaborate with Research and Early Development (REDs) groups (gRED/pRED) and PD colleagues for input and information exchange to ensure success of clinical programs

• Actively participate in cross-functional governance reviews for TA-related discussions (both projects and strategies) to increase quality, productivity and efficiency

Functional Management:

• Directly manage USMA Clinical Program Leaders (CPLs) and Clinical Trial Leaders (CTLs) and provide therapeutic area specific leadership, guidance, clinical trial management expertise and direction to USMA Clinical Operations teams to achieve results:

  • Responsible for ensuring timely and optimal allocation of resources to projects

  • Ensure that your direct reports are trained and proficient in the incorporation of company Standard Operating Procedures (SOPs) and ICH/GCP guidelines for clinical program execution

  • Provide timely and direct feedback to functional managers for team members working in a matrix environment

  • Work with other Clinical Operations Leaders to manage the overall function and to standardize approaches, and increase the productivity and efficiency of clinical operations program management

  • Participate in and/or lead management meetings to plan and implement operational activities to increase quality, productivity and efficiency of the Clinical Operations function

• Facilitate functional initiatives and participate in USMA cross-functional development activities

• Participate in the development of Clinical Operations’ standards, processes and training

• Review and approve expense and other administrative reports/forms as appropriate

Problem Solving & Decision Making:

Problem solving and decision making accountabilities may range from functional to broader Evidence Generation business related activities

Interaction with Others:  

Internal:

• USMA Clinical Operations Leadership Team

• Medical Unit(s) Leadership Team (respective to assigned therapeutic areas)

• Biostatistics Business Units

• Data Sciences

External:

• Alliance Partners

• Contract Research Organizations (CROs)

• Health Authorities

• Healthcare Professionals

• Industry/Medical Associations

• Other Vendors

• Study Sites

Management of Others (complete only if applicable):

The incumbent will also manage a team of direct reports, which may include Clinical Program & Study Leaders, Administrative Associates and contingent workforce employees.

Position Dimensions (complete only if applicable):

Headcount:

Budget:

Revenue:

Requirements:

• Previous Experience Required or Preferred in Related Field (time)

  • 10 or more years’ experience in a leadership role in pharmaceutical/biotechnology research and development

  • 4 or more years’ people management experience

  • 2 or more years’ experience in medical affairs is preferred

  • Experience in managing large budgets

  • Global trial experience is required

• Knowledge, Skills and Abilities

  • Comprehensive knowledge of ICH-GCP and other relevant standards and guidelines

  • Comprehensive knowledge of operational aspects of clinical trial management and the drug development process

  • Knowledge of relevant therapeutic area(s) is preferred

• Technical Experience

  • Expertise in the assigned therapeutic area(s) or ability to quickly learn scientific area

• Educational Background

  • Bachelor's Degree in a medical/science-related discipline

  • Graduate or high-level degree in relevant disciplines is preferred

The Senior Data Scientist of Technical Institute (TI) is a member of the US Medical Affairs Evidence for Access (E4A) Medical Unit. He/she serves as the TI point of contact for E4A health economics outcomes research (HEOR) and health policy and systems research (HPSR) members to design and execute observational research using in-house real-world data (RWD). As a subject expert, he/she may also review and design retrospective observational studies that are conducted by external vendors.

Key responsibilities include:

Collaborate with E4A HEOR and HPSR project owners to identify the appropriate in-house databases (e.g., claims/survey/electronic medical record) and design appropriate methodology to answer specific research questions and to address business need. Participate in E4A strategic planning and lead the execution of in-house RWD studies of E4A HEOR and HSPR project owner. Develop and/or oversee research protocol and statistical analysis plan. Recommend and implement appropriate analytical methodology (e.g., propensity score matching, regression analysis…etc) for RWD studies. Mentor junior staffs/analysts to conduct the analyses, to review the results, and to communicate/publish findings. Lead and oversee the analytic execution to ensure the analyses are conducted with the highest accuracy and quality. Develop knowledge in the covered disease area and identify new data source, method, and collaboration opportunity to address business need. Assist internal stakeholders to review protocol and to support the design of external observational research. Establish a strong partnership with E4A and other stakeholders to ensure high customer satisfaction from the in-house collaboration. Prioritize resource and support based on the business impact of deliverables. Support the Head of E4A TI on operational excellence.

Qualification:

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following knowledge, skills and abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements. Years of experience listed below can be substituted with equivalent, relevant competency levels.

Education and experience

Master and/or doctorate degree in data science, economics, epidemiology, public health, psychology, statistics, or other health services research related disciplines.

A minimal of 6 years previous work experience in consulting, academic/research institute, and/or pharmaceutical industry experience in functions such as health economic outcomes research, epidemiology, statistical analysis, marketing, etc.

Skills and ability

PhD degree in a relevant discipline is preferred Deep expertise in observational research methodology. Ability to design appropriate analyses to answer research questions. Strong oral and writing communication skills to summarize and explain the findings to audiences who may not have technical background. Strong hands-on research and programming (SAS, SQL, and/or R) experience of large claims databases. Excellent knowledge in the US reimbursement coding system A strong track record of publication in peer-reviewed journal Experience in partnering with cross-functional stakeholders Strong attention-to-detail Ability to work collaboratively in a dynamic, team-based environment Ability to prioritize and adjust project plans appropriately Demonstrated ability to learn and embrace new technologies, applications and solutions

*LI-COMM-MG1

Position Purpose:

Strategic local leadership role within CCO. Accountable within the country for providing strategic direction, therapeutic area expertise and overall delivery of all programmes within the assigned therapeutic area in alignment with Roche quality standards, timelines and budget commitments.

The position also provides management, coaching and development of direct reports and identifies and implements areas of best practice and process improvements within the groups they manage and the broader CCO department.

Each CCO region will implement the requirements of this role(s) in the countries, to meet the needs of their stakeholders. Delegation of responsibilities should be clearly defined.

Main Responsibilities and Accountabilities:

• Is accountable for understanding and communicating US CCO development portfolio with internal team, as well as internal and external stakeholders. Drives partnerships with key stakeholders that enable more efficient delivery of portfolio
• Is accountable for the translation of the Therapeutic Area strategy  into effective local clinical operational implementation  plans to ensure country study teams deliver on commitments.Is accountable for the translation of the Therapeutic Area strategy  into effective local clinical operational implementation  plans to ensure country study teams deliver on commitments.
• Has accountability within the local Leadership Team, as a core member, for the oversight of the department, definition of the local vision and strategy, effective mobilisation of the function to align with the strategy, ensuring awareness of opportunities and challenges, fostering of functional excellence, evaluation of metrics and developing operational  performance improvements.
• Is accountable as key strategic  local TA expert and interfaces with internal and external stakeholders for early landscaping, planning, execution and delivery of the  assigned TA portfolio to agreed plans and quality while proactively communicating status, issues and proposed solutions.
• Is a key contributor to supporting, implementing and delivering PDMA/LMA clinical operations strategy within the country, where applicable.
• Leads the local CCO TA input into relevant local/regional/global TA strategic discussions to provide technical and operational  insight, and to challenge and critique, ensuring local competitive landscape, risks and trends are considered.
• Leads local portfolio risk management and is a key contributor to strategic pipeline prioritization, ensuring appropriate commitments are made to SMTs in alignment with overall local and regional strategy.
• Is accountable for overall leadership of local clinical operations study teams to ensure robust project oversight, and develops flexible and innovative local operational  plans with appropriate scenario planning, including forecasting of robust timelines, resources, budget and risk assessment.
• Is responsible  for providing the local CCO function, Country Clinical Operations Leaders and local study teams with thorough, current knowledge of assigned TA, including sharing and explaining applicable clinical development  plans, details of competitive landscape, treatment practices and thought-leading investigators or groups (KOL, TAE).
• Provides strategic oversight of activities of external stakeholders and builds effective relationships with, critical vendors and partners including CROs, clinical sites, KOLs and networks, Co-Development Partners, Cooperative Groups and Academic Alliances as it relates to the designated TA. Identifies new opportunities for collaboration and partnership and fosters excellent partnerships with new and existing strategic partners and clinical sites, in alignment with Roche values.
• Creates and maintains a highly motivated team by providing a high level of leadership, people management, coaching and development.  Ensures effective performance management of direct reports through comprehensive goal setting, regular performance reviews, and by providing direct and timely feedback to direct reports. Fosters a high performance culture that attracts and retains the best talent.
• Proactively fosters a diverse and inclusive culture within the department that is flexible, agile and collaborative and acts as role model for these behaviours within the department.

Qualifications;

University degree or equivalent, preferably in a medical science-related field

Significant experience demonstrated in clinical research/development or related industry

Competencies;

Strategic Planning-- obtains information and identifies key issues and relationships relevant to achieving a long­ range goal; commits to a course of action to accomplish a long-range goal after developing alternatives based on

logical assumptions, facts, available resources, constraints, and organizational values.

Building Partnerships-- develops and leverages relationships within and across work groups to achieve results. Execution-- ensures others contribute  to organizational strategies by focusing them on the most critical priorities,

measuring progress, and ensuring accountability against those metrics.

Business Acumen-- uses knowledge of economic, financial, market, and industry  trends to understand and improve individual, work group, and/or organizational  results; uses understanding of major business functions, industry trends, and own organization's  position to contribute to effective business strategies and/or tactics.

Aligning Performance for Success- focuses and manages individual performance by helping others set performance goals, and then tracking results and evaluating performance effectiveness.

Building Talent - plans and supports the development of individuals' knowledge, skills and abilities so that they can fulfill current or future  job responsibilities more effectively.

Delegation and  Empowerment-- identifies and leverages opportunities to accelerate results and build capability by assigning tasks and decision-making responsibilities to individuals or teams with clear boundaries, expectations, support, and follow-up.

Adaptability··maintains effectiveness when experiencing major changes in work responsibilities or environment (e.g., people, processes, structure or culture); adjusts effectively to change by exploring t he benefits. trying new approaches, and collaborating with others to make the change successful.

Applied Reasoning - is able to solve problems.identify trends and interrelationships between data and information, and effectively reasons through complex challenges.

Influencing··uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support  specific work outcomes.

Inspiring Others-- motivates individuals toward higher levels of performance that are aligned with the organization's vision and values.

Building Networks-- takes action to establish and maintain connections with people outside their formal work group, including those outside the organization (e.g., peers, cross-functional  partners, and vendors), who are willing and able to provide the information, ideas, expertise, and/or influence needed to achieve work goals.

Facilitating Change-- encourages others  to implement better approaches  to address problems and opportunities;

leads the implementation and acceptance of change within the workplace.

Availability to travel domestically and internationally, if required

Travel: Minimum 30%

*LI-PD-BR1

Responsibilities:

We are seeking a postdoctoral fellow to work in the laboratory of Dr. Eric Brown. The incumbent will conduct original and significant basic investigations in the area of the pathogenesis of infectious diseases and host response to infection. The expectation is that this work will result in novel and important contributions to understanding of host-pathogen interactions, as evidenced by publication in top tier scientific journals. The laboratory explores both host and pathogen genetics as its approach to understanding the host-pathogen interface and uses a wide variety of genetic, cell biologic, and biochemical methods to investigate these questions. Projects in the Brown lab currently focus on molecular mechanisms and pathologic consequences of S aureus and P aeruginosa interactions with host cells, including novel bacterial secretion mechanisms involved in virulence.

Requirements:

PhD, MD, or MD/PhD with experience and training in the conduct of research in host-pathogen interactions, microbiology, cell biology, immunology or other relevant area. Significant experience with the techniques of modern molecular and cell biology is necessary. Ability to initiate and complete significant experimental projects, as evidenced by excellent publications, is essential.

*LI-gRED-GL1

Relocation is not designated for this position.

Main Accountabilities and Responsibilities:

• Maximizes the productivity and contribution of the local Study Start-up Team through effective management of team performance, and by developing, coaching and training individual personnel, as needed.
• Oversees the execution of all start-up activities from the time the Study Start-up Specialist (SSUS) is assigned through to site activation, according to agreed project/study strategy, timelines and Roche standards.
• Ensures SSU team members know the applicable regulatory requirements and corresponding related documentation to guarantee adherence and compliance with local regulations.
• Responsible for the ongoing maintenance and analysis of the available study start-up data (metrics) for their country/region and for understanding the local environment (e.g. regulatory, government policies/laws, etc.); drives increased efficiency, reduction in overall start-up timelines and identification of opportunities for continuous improvement.
• Partners with Therapeutic Area Leaders (TALs), Business Support Leads (BSLs), Country Study Managers (CSMs), etc., to ensure understanding of protocol and planned execution strategies; develops a study start-up strategy that meets study/project requirements.
• Partners with TALs to identify key sites/institutions and ensures implementation of relevant strategic partnership arrangements to maximize efficiency, as needed.
• Represents the country and is local SPOC in the SSU network within the regional/global organization, as applicable.
• Accountable for the budget and contract negotiation process, where applicable, and for ensuring adherence to FMV (Fair Market Value); escalates concerns regarding the budget and contract back to the Country Study Manager and/or local FMV Manager for approval, as needed.
• As a member of the local Leadership Team, helps design and supports the local/regional vision and strategy, as applicable.

Qualifications:

• University Degree or equivalent, preferably in a medical/science-related field.
• Demonstrated knowledge and understanding of clinical trials and experience in managing projects. Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country. Previous line management experience/supervision of staff is preferred.

Competencies:

• Decision Making — identifies and understands problems and opportunities by gathering, analyzing and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints, and optimizes probable consequences.
• Facilitating Change — encourages others to implement better approaches to address problems and opportunities; leads the implementation and acceptance of change in the workplace.
• Driving for Results — sets high goals for personal and group accomplishment; uses measurement methods to monitor progress toward goals; tenaciously works to meet or exceed goals while deriving satisfaction from that achievement and from continuous improvement.
• Communication -conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.
• Influencing — uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
• Building Partnerships — develops and leverages relationships within and across work groups to achieve results.
• Planning & Organizing — establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines and leveraging resources.
• Customer Orientation — places a high priority on the internal or external customer’s perspective when making decisions and taking action; implements service practices that meet the customer’s and own organization’s needs.
• Technical/Professional Knowledge and Skills has achieved a satisfactory level of technical, functional and/or professional skill or knowledge in position-related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.
• Business Acumen -uses knowledge of economic, financial, market and industry trends to understand and improve individual, work group and/or organizational results; uses understanding of major business functions, industry trends and own organization’s position to contribute to effective business strategies and/or tactics.

Other:

• Availability to travel domestically and internationally if required.

#LI-PD-BR1

The Clinical Specialist, Lung – Chicago South manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory.  As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state. 

Reports to: Division Manager, Franchise Sales

Example Duties and Responsibilities: 

• Responsible for meeting or exceeding assigned sales targets 
• Develops robust territory business plans 
• Develops strong and long-term relationships with customers in all assigned accounts 
• Highly collaborative with territory partner and other internal, cross-functional stakeholders
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands 
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, is regularly required 

Key Competency Profile:

• Teamwork & Collaboration
• Communication
• Technical & Business Expertise
• Achieving Results
• Strategic Agility

Qualifications and Experience: unless stated as “preferred” or “a plus,” all other criteria is required

• Bachelors Degree 
• Average of 2 or more years’ work experience 
• Previous sales experience in the pharmaceutical, biotech, or related industry
• Proven track record of meeting or exceeding objectives & goals 
• Previous experience in achieving specific sales plans or other financial targets is preferred  
• Competitive Selling Skills
• Outstanding interpersonal, selling, presentation, influencing and negotiation skills: you have highly developed consultative selling skills and help your customers find solutions to their needs or problems
• Demonstrated ability to work in a highly collaborative, team environment

This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

This is a remote position

*LI-COMM-MG1

Position requires working in the South San Francisco office.  Relocation / sponsorship assistance will not be provided.   Contractor will be an employee of ProUnlimited, assigned to Genentech.

The Access Solutions Case Manager acts as a liaison between patients, providers, distributors, and insurance carriers to assure services are provided in the least restrictive and least costly manner.  The Case Manager reports to the Case Management & Reimbursement Supervisor and is an individual contributor.

Key Responsibilities/Accountabilities: 

• Provide reimbursement support to patients, pharmacists, physicians, and internal sales force.
• Educate, inform, and assist patients (and their families) and providers to navigate through the reimbursement and appeal process for the assigned product.
• Identify barriers to reimbursement and continually identify and recommend program efficiencies to the Supervisor to promote a high quality of work by Access Solutions staff. 
• Identify and facilitate referrals to alternative coverage options and financial assistance programs for patients who are under insured or require copy assistance.
• Establish relationships with appropriate stakeholders including internal & external partners.
• May conduct benefits coverage and payer research/investigations to ensure appropriate resources, compliance with payer appeal policies, practices, and timelines.
• Periodic mandatory overtime throughout the year is required in Access Solutions Operations.  This may include, but is not limited to, high referral season (Blizzard, Enrollment renewal), new product or system launches, new line extensions, or any unexpected surge in volume or backlog situations. May include weekends as needed.

 Competencies:

• Communication
• Inspiring and Influencing
• Teamwork and Collaboration
• Achieving Results

Recommended Skills and Experiences:

• Bachelor’s degree is preferred.
• 3 years of reimbursement experience preferred.
• Candidate must have excellent knowledge of the managed care industry, including government payers.
• Proficiency in all aspects of reimbursement (i.e., benefit investigations, payer reimbursement policies, regulatory and administrative rules).
• Understands reimbursement/funding resources and how to access these resources.
• Demonstrates effective problem-solving skills and provides excellent customer service.
• Excellent investigational and analytical skills with a proven ability to communicate effectively in both written and verbal format.
• Ability to work collaboratively in a team structure and responsibly delegate next steps to appropriate team members.
• Must be able to work effectively under pressure and prioritize tasks.
• Must be able to follow written Standard Operating Procedure.

*LI-COMM-MG1

Position Summary

The digital center of excellence is a functional group within Genentech Business Operations (GBO) comprised of experienced digital experts who partner across CMG to orchestrate and deliver integrated digital customer experiences that drive measurable business outcomes.

The Program Manager reports to the Program Manager Team Lead and plans and orchestrates delivery of business programs and integrated digital customer experiences.  This individual also lives the CMG Operating Principles (I am Genentech’s Ambassador, I Partner with Purpose, I Own Our Business, I am Empowered for Action). 

Key Responsibilities

• Design integrated cross-channel plans that drive results, enable optimization, and quality delivery of digital campaigns.
• Partner with CMG partners to understand business goals and provide inputs for resourcing to support delivery against these goals. Ensure dependencies/timelines understood, managed, and communicated to key stakeholders.
• Orchestrate delivery of customer experiences in partnership with CMG. Leverage expertise to optimize, refine, and enhance these experiences to drive customer satisfaction.
• Accountable for compliance. Works in alignment with the Promotional Review Committee (PRC) and Healthcare Compliance Office (HCO) systems and policies to ensure development of compliant and effective promotional tactics.
• Establishes work priorities and timelines, exercises judgment in selecting methods for approaching new projects, and demonstrates influence in aligning CMG partners to meet cross-channel needs.

Skills

• Working knowledge across a range of Digital & Product Marketing responsibilities.  Applies emerging knowledge and trends in one’s area of expertise to improve results, and keep partners informed of new service offerings.
• Working knowledge of the healthcare ecosystem including the regulatory environment, each customer type - e.g. HCPs, patients, payers, and how they interact
• Is goal-directed, persistent; driven to achieve objectives. Holds self accountable for commitments and holds partners accountable for delivering on business strategies.
• Solution-driven, demonstrating the ability to proactively overcome hurdles and providing solutions to meet objectives
• Analytical skills to effectively interpret and utilize quantitative and qualitative data to influence planning and optimization.
• Ability to influence and inspire individuals and teams across CMG network. Builds credibility with key stakeholders. Contributes expertise to help colleagues within and beyond digital area. Demonstrates ability to foster exchange of ideas, drives key decisions and business outcomes by employing effective engagement and influence skills
• Demonstrates an enterprise mindset, integrating digital knowledge with a broader business perspective and appreciation for our markets, customers, and the overall biotech industry
• Strong communication and partnering skills. Works effectively and efficiently in a cross-functional model, aligning requirements and scope with internal/external stakeholders. Recognizes the contributions of teammates and peers.
• Ability to translate strategic direction into action plan for self, and make progress in the face of ambiguity. Ability to flex and thrive in an ambiguous environment undergoing transformational change.

Qualifications

• Bachelor's degree; MBA or other related graduate level degree preferred
• Minimum 8+ years of work experience in a sales & marketing program, project or process management role
• PMP certification a plus
• 5+ years experience in multichannel/digital marketing
• Experience in the managed care, pharmaceutical, or biotech industry
• Working knowledge of the digital COE marketing technology stack, processes, workflow, and measurement tools

The DevOps Engineer will oversee code releases and manage the IT infrastructure that's needed to support software code in our cloud environments. Provision required resources, select an appropriate deployment model, direct the testing protocol to validate release and monitor performance after release. Tasks may include preparing test data, analyzing results, troubleshooting problems and communicating issues back to development.

Main tasks and duties

- Act as subject matter expert for the whole Solution & Software in regards to DevOps topics;

- Define and maintain the Solution & Software DevOps strategy for IT products organization;

- Validate the different program DevOps activities and the adherence to the overall Roche strategy;

- Provide support for programs and products during the whole development lifecycle (e.g. PoC, collaborate in feasibility studies, participate in technical spikes, etc.);

- Contribute to the identification of program-relevant shortcomings / needs in the different Solution & Software activities and trigger related initiatives;

- Drive the DevOps tooling selection to maximize the standardization within IT Products organization, manage license usage and act as main contact with other areas regarding tooling;

- Responsible for creation and maintenance of the best practices documents associated with the different Solution and Software activities and aligned with the division standards;

- Lead and monitor the DevOps related team activities together with our business partner;

- Represent IT Products organization on IT, toolchain and Solution Software DevOps in the Roche global communities.

Communication

- Responsible for ensuring effective and efficient communication within the team;

- Responsible for defining, adjusting and maintaining the DevOps Board structure and process;

- Responsible for the proactive involvement and alignment with all interfacing organization units inside and outside RDC;

- Responsible for ensuring effective and efficient reporting to enable proactive management and handling of important and urgent issues within the team;

- Strong communication skills with both external team members and internal business stakeholders;

- Strong communication and negotiation skills with stakeholders;

- Strong initiative to find ways to improve solutions, systems, and processes.

Required Lead DevOps Competencies

- Understanding of DevOps patterns and best practices;

- Understanding of System, Solution and Enterprise DevOps definition and execution;

- To permanently optimize processes to increase quality and efficiency standards;

- Overall understanding of the domain and Roche’s processes and regulatory constraints;

- Leadership skills to facilitate collaboration and challenge status to drive results;

- Able to perform adequate stakeholder management and lead the process to a successful outcome.

Knowledge & Experience Required

Has worked with and has proficiency with DevOps tools in the following areas:

- Version Control (Git);

- Continuous Integration (Jenkins);

- Microservices application architecture (Docker, Kubernetes);

- Solid knowledge of Amazon Web Services;

- Strong background in configuration management tools like Chef, Puppet, TF and Ansible;

- Familiarity and understanding of security practices and DevSecOps automation;

- BS/BA degree in Computer Science, Information Systems or related field;

- Experience supporting deployments and builds in critical environments;

- Working knowledge of Agile Software Development Life Cycle (SDLC) methodology (processes, and deliverables);

- 3+ years scripting languages.

Job Purpose

• Manage the day-to-day DevOps internal activities and with 3rd parties for delivering high quality digital solutions in a fast paced environment.
• Ensure processes, procedures, and tools to build mobile and cloud based software in an agile environment are in place.
• Help define delivery strategies and collaborate across development and operations teams to deliver successful digital solutions.

  Key Accountabilities

• Maintain environments ensuring they are consistently setup and configured.
• Manage and deploy processes and tools.
• Establish and ensure processes are in place and followed to allow continuous integration and delivery.
• Setup and ensure proper technology and tools are in place to allow continuous integration and delivery.
• Continuous improvement of build and testing processes.
• Troubleshoot, trace and isolate build and delivery issues versus code issues.
• Drive collaboration across stakeholder representatives from all aspects of the project, including developers, testers, architects and operations.
• Manage operational relationship with third party suppliers, consultants and contractors for delivery of digital solutions.

  Key Performance Indicators

• Enable systems and environments for high frequency deployments.
• Accelerate deployment speeds.
• Increase Deployment success rates and minimize defects and incidents.
• Mean time to restore services.
• Security test pass rate.

  Key Skills/Experience

• 3+ years of experience administering continuous integration and continuous deployment tools (Jenkins, Puppet, Nagios, Docker, Splunk, Grafana…).
• 3+ years of experience working with web and mobile applications environments, cloud technologies, web service concepts (REST, JSON, XML) and micro-services architecture
• 5+ Agile methodology experience (Scrum, Kanban…).
• Solid understanding and practical experience of software development life cycles, with emphasis on release engineering functions.
• Experience with source code branching and merging strategy with Git and managing build tools (maven, ant, etc.).
• Experience with building/deploying/managing AWS on an enterprise level.
• Experience working with relational DB and non-SQL DB (Cassandra, MongoDB, etc.).
• Proficient in Linux Shell scripting.
• Proficient in developing/programming (Python, Java, Ruby, etc.).
• Experienced with configuration management (Salt, Ansible, Puppet, or Chef).
• Excellent at building workflows and processes around releasing code through multiple environments.
• Excellent customer service attitude, communication skills and interpersonal skills.
• Excellent analytical and problem-solving skills.
• Ability to think innovative, strategically and solid judgment and how/when to escalate.

The power of data at scale has transformed almost every industry, personalizing experiences in many aspects of our lives. Yet in healthcare we’ve only scratched the surface. At Genentech and Roche we are accelerating the use of data insights and digital technologies to make significant strides to reach the full potential of personalized healthcare. We are seeking mission-driven, ardent, self-starting, creative individuals to join us in this effort.  

The Principal Personalized Patient Care & Access (PPC&A) Architect will work closely with key stakeholders in the PHC Center of Excellence  and serve as trusted IT strategist to coordinate technology strategy with the PHC COE strategy and portfolio. Responsible for driving the development of an IT strategic plan and works with senior stakeholders to identify technologies which enables the business to achieve its PHC 2.0 vision and strategy. Specifically, the role will bring technology knowledge and leadership working with affiliates to identify, develop and secure innovative partnerships with select healthcare systems. These partnerships represent “system-level” experiments on the clinical practice of oncology; utilizing PHC technologies and therapies in new ways. Successful delivery will result in creating an integrated infrastructure that will serve as the “technology back-bone” to support new treatment/payment models as well as new ideas for Roche and healthcare systems on sustainable innovation. Provides the business stakeholders a window to key innovative technology trends and evolution of technology within the healthcare  industry, which has the potential to accelerate the fulfillment of the strategic vision. Through use of dashboards and governance boards, provides continuing communication to provide the business an overview of the progress of current IT innovation(s).

We expect the Principal Personalized Patient Care & Access (PPC&A) Architect to be a passionate business and product advocate within IT, with proven analytical capabilities. The Principal Personalized Patient Care & Access (PPC&A) Architect must be an effective negotiator, leader and communicator in working with Roche/Genentech’s multiple business units as well as with internal IT cross-functional teams. The ideal candidate will be a self-starter with a passion for transforming healthcare, a high level of flexibility, and commitment. The Principal Personalized Patient Care & Access (PPC&A) Architect will join our diverse community of smart, fun, wholehearted, and engaged informatics professionals from various functional areas. This person will share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, “doing now what patients need next.”

Responsibilities:

As Principal Personalized Patient Care & Access (PPC&A) Architect on the PHC Pharma IT/Technology team, you will:

• Partner closely with key stakeholders from PHC Center of Excellence, Global Head Shining Towers, and Commercial/Medical Global/Affiliate business groups, and corresponding Pharma IT Groups and Global Infrastructure and Solutions (GIS).

• Influence senior leaders across Roche and communicate PHC IT/Technology vision, strategy, goals, status, and impact.

• Develops the technology strategy, architecture, and critical investment plan in strategic technologies.

• Ensures that the technology architecture and technical strategies remain current with the business goals, and directs the development of architecture activities and projects, while aligning with current and long-term business and technology goals.

• Understands the organizational direction, goals and industry competitive environment to determine how architecture can add value to the organization and to business. Makes expert recommendations and decisions clearly linked to the organization's strategy and financial goals.

• Promotes best practices to support scalability, skills transfer and organizational change management across the enterprise and architecture community.

• Highlights short-term trade-offs vs long-term commitments and where those are worth implementing or not. Ensures that the Solutions are scalable (technology), efficient (process), effective (cost), and supportable.

• Mentor technical leads/software engineers to enable the individuals and the organization to develop a scalable and stable solution landscape.

• Have a broad knowledge and leverage the technical capabilities of the internal teams and external technology providers and vendors.

• Conduct market assessments and to identify new capabilities for existing and future business needs.

• Collaborate with other Strategy and Architecture groups across Roche.

Qualifications:

• Bachelor’s degree in Biology, Computer Science, Mathematics, Electrical Engineering, Information Systems or related field; Master/PHD in Business, Mathematics, Science, or Computer Science preferred

• Overall 10+ years experience in product delivery and architecture, of which at least 5-10 years as an Architect and 5-10 years in Product Delivery as a Program Manager

• 3+ years of people management experience preferred

• Demonstrated experience with full life-cycle product management: problem definition and solution discovery, stakeholder buy-in, validation, launch, and ongoing operations

• Strong, broad conceptual understanding of provider/payer IT systems, and 3+ years of hands-on experience with technology such as clinical enterprise technology (EMRs), Decision Support Systems, Clinical Workflows

• 5+ years of proven experience in designing and implementing enterprise scale clinical enterprise technology (EMR/EHR) systems, Omics/Imaging/Digital systems, and industry interoperability standards and concepts such as HL7/FHIR

• Proven knowledge of HIPAA, GDPR and other healthcare compliance/regulatory requirements.

• Proven Knowledge and Experience in designing, implementing Clinical Decision Support Systems, Digital Health/Sensor Applications, Patient Engagement Platform is required

• 3+ years experience across multiple big data platforms, ETL, data modeling, and business intelligence big data architectures. Experience with the Hadoop ecosystem (Map Reduce, Spark, Oozie, Impala, HBase, etc.) and big data ecosystems (Kafka, Cassandra, etc.) with experience in at least one of the  SQL language is preferred

• Experience in designing and implementing multi-tenant cloud platforms that rely on large scale datasets and solid understanding of cloud architecture and stacks

• Proven ability to relate and adapt vision and strategy to the external environment that affects the organization in terms of economic climate, customer market demand, regulation and other legalities, geography, culture, technology

• Excellent communication (written and oral) and presentation skills; solid business acumen; well-honed influencing skills are essential

• Self-motivated and team-oriented; able to work both autonomously and effectively as part of a geographically dispersed team

• Ability to travel up to 25% time

Genentech’s Intellectual Property team is seeking a collaborative and innovative seasoned patent attorney or agent who loves to think and act outside the box to create game-changing IP strategies that will enable Roche & Genentech to do now what patients need next.  As an IP team member, this individual is versatile and passionate in handling new ways to craft IP positions & protection for groundbreaking innovation.  You will be working with scientists, attorneys, patent agents, and staff across a dynamic & diverse global organization pushing the boundaries of what is possible in a highly competitive industry. This position will be located in our South San Francisco campus and will report to the lead of our Biosimilars, Manufacturing & Litigation Readiness team.

Position Scope and Key Responsibilities:

• Perform invention harvesting, global patent preparation and prosecution, portfolio development and management, IP searching and/or landscaping, due diligence assessments, freedom-to-operate, infringement and validity analyses, and risk evaluation and mitigation strategies individually and in cross-functional global teams for our innovative manufacturing processes & business
• Develop and/or maintain database tools to support freedom-to-operate and due diligence assessments for large molecule manufacturing
• Develop an understanding of the technology and business strategy of the groups this position supports to both inform the various IP initiatives as well as the underlying business decision-making processes
• Advise the business stakeholders on IP strategies, risk & associated mitigation strategies associated with BPCIA risk evaluation, deploy mitigation strategies across product portfolios
• Provide IP diligence, advice and strategy for IP transactions with transactional legal group to business development, research and intellectual property functions and the global manufacturing business in support of local and globally-driven collaborations, licenses, mergers, acquisitions, equity investments, and divestitures
• Regularly anticipate future challenges and risks to the company and innovate to find solutions and create business value in response to a highly competitive, dynamic marketplace that includes innovators & biosimilar competitors
• Foster strong, collaborative relationships with stakeholders across global sites and create efficient and effective processes for communicating, advising and working with stakeholders at all levels of the organization
• Direct & manage outside counsel, related budgets and, where applicable, negotiate rates, project fees, and timelines
• Cultivate a culture that reflects a strong commitment to diversity, inclusion and community

KEY SELECTION CRITERIA:

Critical Competencies:

Manufacturing Process IP Expert:

• Demonstrates expertise in global patent portfolio preparation, prosecution, and enforcement for commercially-relevant materials, products or processes
• Works with therapeutic molecules, modalities and related technologies that are in development or being commercialized
• Conducts patent database searches and rapidly parses through large amounts of information to identify relevant material
• Understands and fluent about research tools, processing technologies and/or manufacturing technologies
• Creates and uses complex spreadsheets (e.g., Excel) and/or databases to manage large amounts of information

Adaptive and Results-oriented Go-Getter:

• Works rapidly, independently and proactively with minimal direction
• Exhibits excellent judgment, pragmatism, and negotiation skills
• Demonstrates strong organizational skills, keen attention to detail, and ability to prioritize projects and meet aggressive deadlines
• Balances competing priorities while managing IP portfolios; multitasking with ease
• Innovates and creates business value

Collaborative Partner:

• Demonstrates exceptional and consistently clear communication, both oral and written, to all levels of an organization as well as a willingness to listen and learn from others
• Works effectively both independently and in global and cross-functional teams
• Manages external relationships with outside counsel and collaborators
• Fosters teamwork and collaboration with other teams, and influences and resolves conflict

Requirements: Ideal Experience and Education

• 7+ years in creating, prosecuting, and advising on complex global patent portfolios & associated strategies relating to commercially-relevant materials, products or processes
• Undergraduate or (preferably) advanced degree in chemical engineering, process engineering, materials science engineering, physical sciences, materials sciences, chemistry, biochemistry, or molecular biology; a strong technological aptitude for learning and working with a range of technologies
• If J.D., then admission to a U.S. State bar or the District of Columbia bar
• Admission to the United States Patent & Trademark Office Bar
• Solid knowledge of global intellectual property laws & practices
• Adverse proceedings (e.g., USPTO adverse proceedings, EPO adverse proceedings, IPRs, and/or US litigation) is a plus
• Strategic legal advisor in a corporation, including providing advice on complex licensing and/or other transactional matters is a plus

*LI-CG-CY1

• Summary of Position:

  The PV Clinical Specialist supports the drug safety staff in the strategic and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety.   The PV Clinical specialist is responsible for the oversight of study related activities in collaboration with other functional groups, serves as the single point of contact with Pharma Development Safety Science, and supports the US Drug Safety  PV Clinical Manager- Specialist in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Specialist.

  Key Accountabilities (The E4 and E5 PV Clinical Specialists will perform some or all the following activities):

  • Functions as the subject matter expert for all types of case processing, provides guidance, and oversight of ICSR quality within PV Clinical Team
  • Provides strategic input on case processing activities performed by the PV support team
  • Performs trend analysis for ICSRs processed in global safety database
  • Provides feedback and escalates [if required] to PV clinical management of any trends observed
  • Assists senior PV specialists in performing enhanced follow up activities [as required]
  • Assists in case process related activities during audits and inspections
  • Demonstrates expertise of appropriate labeling documents for Genentech/ Roche molecules and products and performs labelling assessment for AE(s) received using clinical knowledge
  • Demonstrates understanding of local and global health authority requirements pertaining to ICSR processing
  • Responsible for maintaining compliance with health authority regulations and guidance documents pertaining to ICSR submissions
  • Responsible for the oversight and implementation of internal Manuals, global / local safety SOPs / Work Instructions (applicable to USDS) and external collaborations agreements, e.g. PVAs and SDEAs
  • Responsible for the oversight of identifying, creating additional, or updating existing local Guidance Documents including but not limited to training matrix, identify appropriate target audience for training assignment
    • Demonstrates expert knowledge of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) in order to oversee and lead the protocol review process for sponsored/managed and supported/funded studies for molecules/products in assigned therapeutic areas
  • Accountable for providing PV oversight to appropriate study/molecule teams
    • Accountable for Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche sponsored and supported studies based on medical knowledge and European Union (EU) regulations
    • Reviews Safety Data Exchange Agreements and Safety Management Plans (as applicable)
    • Responsible for the assignment of molecule and therapeutic area assignments and tracking
    • Reviews Safety Data Exchange Agreements and Safety Management Plans and provides guidance on related documents (as applicable)
  • Actively participates as a member of the Study Management Team and performs PV activities including but not limited to: Providing presentations for investigator meetings, oversee clinical trial reconciliation and/or Case Transmission Verification (CTV)  (as applicable), acts as a single point of contact for safety related concerns, and acts as a safety liaison between safety science, Study Review Team (SRT), Study Management Team (SMT), and any similar governing bodies.

  Oversees Safety related activities for assigned Genentech/ Roche Product(s) managed by US Medical Affairs to include

  • Demonstrates advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)
  • Provides medical team molecule support in appropriate safety areas
  • Advises medical teams conducting interventional or non-interventional research that improves the care of patient from safety perspective
  • Independently oversees signal detection and validation for aggregate data received by USDS (e.g, PBRER, PSUR etc.)
  • Responsible for ensuring oversight and appropriate classification of all activities under USMA
  • Exhibits total knowledge of study classification (i.e, interventional studies, non-interventional studies, post-approval safety studies (PASS), registries, etc.)
  • Communicates and updates Team of any process related issues/ concerns
  • Acts as single point of contact for safety related concerns
  • Acts as Safety Liaison between Safety Science and Medical Team.
    • Expert knowledge of the Genentech/ Roche Product(s) safety profile(s) and appropriate labeling documents
    • Provides guidance on the medical review of safety related documents, including but not limited to pregnancy letters and develop a plan of action to mitigate any risk
    • Prepares written responses to drug safety queries from Health Care Professionals using the locally available information and/or initiating literature searches as required and/or initiating an investigation by Drug Safety Contact Line (global) as needed
    • Responsible for implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules / products, with the ability to function as the RMP IC (as required)
  • Responsible for performing and overseeing health authority submissions via thorough understanding of FDA regulations as per code of Federal regulations (CFR)
    • Responsible for regular review of US submission rules within the safety database
    • Acts as a single point of contact for submission related inquiries
    • Liaises with internal/external stakeholders (i.e., PV information system, PDSS, regulatory, health authorities as applicable) to understand and implement regulatory requirements or any applicable changes
  • Develops, performs, and provides input on drug safety presentations for internal /external stakeholders as applicable.
  • Responsible for identifying any deviations or process improvements including corrective and preventive actions Contribute PV expertise to Genentech work products and coach/mentor others as needed
  • Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions
  • Manages all PV related activities or commitments are appropriately actioned for assigned therapeutic areas which include but not limited to overseeing all study activities performed by individual molecule responsible
  • Participates in preparation on abstracts, posters, and presentation for medical/ scientific meeting and/or congresses based on the collaborative initiatives
  • Acts as single point of contact with key stakeholders for safety related activities and acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs.
  • Works closely with PV Clinical Manager to be aware of any safety issues / concerns and assist or leads special projects as assigned by and under the direction of the US Drug Safety PV Clinical Manager and/or other Safety personnel.
    • Provide support during audits and inspections.
    • Collaborates with PV Operations and SP PV Oversight teams as needed

  E4 PV Clinical Specialists

  The PV Clinical Specialists demonstrates expert knowledge of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) to oversee and lead the protocol review process for supported/funded studies for molecules/products in assigned therapeutic areas under limited direct from the PV Clinical Specialist Manager. PV Clinical Specialist also provides guidance to PV Clinical Support staff as needed. Accountable for providing PV oversight to appropriate study/molecule teams and for activities concerning SRT or other similar governing bodies

  E5 Senior PV Clinical Specialists - Expert in all PV Clinical Specialist activities in addition to the following:

  Demonstrates expert knowledge of all PV clinical related activities and provides guidance to PV Clinical Specialist and support staff. Is also primarily responsible for all sponsored studies and medical team (or similar governing bodies) related activities.

  Provides strategic input in collaboration with the PV Clinical Managers / PV Clinical Head and can work independently within PV Clinical activities. Acts as an expert on Health Authority Regulations and supports PV Clinical Managers with interpretation of these regulations. Takes accountability for cross-functional projects and achieves desired results with minimal supervision. Identifies process improvements, establishes new standards and techniques to improve PV standards and compliance as required.

  Competencies Identified for Success:

  • Demonstrates capability to comprehend, and analyze medical information
  • Works effectively, independently and collaboratively
  • Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
  • Demonstrates ownership, initiative, accountability, and the ability to manage change
    • Strong customer orientation/focus
    • Ability to flex and thrive in an agile and fast changing environment
    • Works well independent or within teams and is effective in collaborating with others internally and externally
    • Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems and effectively make decisions of moderate complexity and scope e.g. evaluate, interpret and present highly complex data
    • Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
    • Ability to effectively and efficiently manage multiple priorities
  • Good interpersonal and influencing skills; can effectively and quickly establish rapport with all key internal/external partners and stakeholders and influence without authority
  • Good negotiation skills: can drive discussions and decisions towards desired results
  • Understanding of legal and regulatory considerations impacting pharma/biotech industry and ability and judgement to apply principles to daily activities
  • Strong attention-to-detail

  Education, Experience, and Other Requirements:

  • Health Care Professional bachelor degree with strong academic background (e.g. RN/BSN/MSN, NP, RPh/ PharmD/ B.Pharm or MD) (Required)
  • Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite) (Preferred)
  • Able to travel as per business needs
  • 1-3 years of pharmaceutical/biotechnology relevant industry experience preferred - preferably in Medical Affairs or product development or is a recognized expert in the field or therapeutic area (with a minimum of 2 years’ clinical experience)
  • Considerable experience in the principles and techniques of data analysis, interpretation and clinical relevance, medical writing
  • Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.) preferred
  • Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development 
  • Considerable experience in the principles
  • Proven track record of meeting or exceeding objectives and goals

   #LI-COMM-RS

• Internal Job DescriptionInternal Job Description

  Summary of Position:

  The PV Clinical Specialist supports the drug safety staff in the strategic and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety.   The PV Clinical specialist is responsible for the oversight of study related activities in collaboration with other functional groups, serves as the single point of contact with Pharma Development Safety Science, and supports the US Drug Safety  PV Clinical Manager- Specialist in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Specialist.

  Key Accountabilities (The E4 and E5 PV Clinical Specialists will perform some or all the following activities):

  • Functions as the subject matter expert for all types of case processing, provides guidance, and oversight of ICSR quality within PV Clinical Team
  • Provides strategic input on case processing activities performed by the PV support team
  • Performs trend analysis for ICSRs processed in global safety database
  • Provides feedback and escalates [if required] to PV clinical management of any trends observed
  • Assists senior PV specialists in performing enhanced follow up activities [as required]
  • Assists in case process related activities during audits and inspections
  • Demonstrates expertise of appropriate labeling documents for Genentech/ Roche molecules and products and performs labelling assessment for AE(s) received using clinical knowledge
  • Demonstrates understanding of local and global health authority requirements pertaining to ICSR processing
  • Responsible for maintaining compliance with health authority regulations and guidance documents pertaining to ICSR submissions
  • Responsible for the oversight and implementation of internal Manuals, global / local safety SOPs / Work Instructions (applicable to USDS) and external collaborations agreements, e.g. PVAs and SDEAs
  • Responsible for the oversight of identifying, creating additional, or updating existing local Guidance Documents including but not limited to training matrix, identify appropriate target audience for training assignment
    • Demonstrates expert knowledge of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) in order to oversee and lead the protocol review process for sponsored/managed and supported/funded studies for molecules/products in assigned therapeutic areas
  • Accountable for providing PV oversight to appropriate study/molecule teams
    • Accountable for Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche sponsored and supported studies based on medical knowledge and European Union (EU) regulations
    • Reviews Safety Data Exchange Agreements and Safety Management Plans (as applicable)
    • Responsible for the assignment of molecule and therapeutic area assignments and tracking
    • Reviews Safety Data Exchange Agreements and Safety Management Plans and provides guidance on related documents (as applicable)
  • Actively participates as a member of the Study Management Team and performs PV activities including but not limited to: Providing presentations for investigator meetings, oversee clinical trial reconciliation and/or Case Transmission Verification (CTV)  (as applicable), acts as a single point of contact for safety related concerns, and acts as a safety liaison between safety science, Study Review Team (SRT), Study Management Team (SMT), and any similar governing bodies.

  Oversees Safety related activities for assigned Genentech/ Roche Product(s) managed by US Medical Affairs to include

  • Demonstrates advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)
  • Provides medical team molecule support in appropriate safety areas
  • Advises medical teams conducting interventional or non-interventional research that improves the care of patient from safety perspective
  • Independently oversees signal detection and validation for aggregate data received by USDS (e.g, PBRER, PSUR etc.)
  • Responsible for ensuring oversight and appropriate classification of all activities under USMA
  • Exhibits total knowledge of study classification (i.e, interventional studies, non-interventional studies, post-approval safety studies (PASS), registries, etc.)
  • Communicates and updates Team of any process related issues/ concerns
  • Acts as single point of contact for safety related concerns
  • Acts as Safety Liaison between Safety Science and Medical Team.
    • Expert knowledge of the Genentech/ Roche Product(s) safety profile(s) and appropriate labeling documents
    • Provides guidance on the medical review of safety related documents, including but not limited to pregnancy letters and develop a plan of action to mitigate any risk
    • Prepares written responses to drug safety queries from Health Care Professionals using the locally available information and/or initiating literature searches as required and/or initiating an investigation by Drug Safety Contact Line (global) as needed
    • Responsible for implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules / products, with the ability to function as the RMP IC (as required)
  • Responsible for performing and overseeing health authority submissions via thorough understanding of FDA regulations as per code of Federal regulations (CFR)
    • Responsible for regular review of US submission rules within the safety database
    • Acts as a single point of contact for submission related inquiries
    • Liaises with internal/external stakeholders (i.e., PV information system, PDSS, regulatory, health authorities as applicable) to understand and implement regulatory requirements or any applicable changes
  • Develops, performs, and provides input on drug safety presentations for internal /external stakeholders as applicable.
  • Responsible for identifying any deviations or process improvements including corrective and preventive actions Contribute PV expertise to Genentech work products and coach/mentor others as needed
  • Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions
  • Manages all PV related activities or commitments are appropriately actioned for assigned therapeutic areas which include but not limited to overseeing all study activities performed by individual molecule responsible
  • Participates in preparation on abstracts, posters, and presentation for medical/ scientific meeting and/or congresses based on the collaborative initiatives
  • Acts as single point of contact with key stakeholders for safety related activities and acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs.
  • Works closely with PV Clinical Manager to be aware of any safety issues / concerns and assist or leads special projects as assigned by and under the direction of the US Drug Safety PV Clinical Manager and/or other Safety personnel.
    • Provide support during audits and inspections.
    • Collaborates with PV Operations and SP PV Oversight teams as needed

  E4 PV Clinical Specialists

  The PV Clinical Specialists demonstrates expert knowledge of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) to oversee and lead the protocol review process for supported/funded studies for molecules/products in assigned therapeutic areas under limited direct from the PV Clinical Specialist Manager. PV Clinical Specialist also provides guidance to PV Clinical Support staff as needed. Accountable for providing PV oversight to appropriate study/molecule teams and for activities concerning SRT or other similar governing bodies

  E5 Senior PV Clinical Specialists - Expert in all PV Clinical Specialist activities in addition to the following:

  Demonstrates expert knowledge of all PV clinical related activities and provides guidance to PV Clinical Specialist and support staff. Is also primarily responsible for all sponsored studies and medical team (or similar governing bodies) related activities.

  Provides strategic input in collaboration with the PV Clinical Managers / PV Clinical Head and can work independently within PV Clinical activities. Acts as an expert on Health Authority Regulations and supports PV Clinical Managers with interpretation of these regulations. Takes accountability for cross-functional projects and achieves desired results with minimal supervision. Identifies process improvements, establishes new standards and techniques to improve PV standards and compliance as required.

  Competencies Identified for Success:

  • Demonstrates capability to comprehend, and analyze medical information
  • Works effectively, independently and collaboratively
  • Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
  • Demonstrates ownership, initiative, accountability, and the ability to manage change
    • Strong customer orientation/focus
    • Ability to flex and thrive in an agile and fast changing environment
    • Works well independent or within teams and is effective in collaborating with others internally and externally
    • Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems and effectively make decisions of moderate complexity and scope e.g. evaluate, interpret and present highly complex data
    • Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
    • Ability to effectively and efficiently manage multiple priorities
  • Good interpersonal and influencing skills; can effectively and quickly establish rapport with all key internal/external partners and stakeholders and influence without authority
  • Good negotiation skills: can drive discussions and decisions towards desired results
  • Understanding of legal and regulatory considerations impacting pharma/biotech industry and ability and judgement to apply principles to daily activities
  • Strong attention-to-detail

  Education, Experience, and Other Requirements:

  • Health Care Professional bachelor degree with strong academic background (e.g. RN/BSN/MSN, NP, RPh/ PharmD/ B.Pharm or MD) (Required)
  • Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite) (Preferred)
  • Able to travel as per business needs
  • 1-3 years of pharmaceutical/biotechnology relevant industry experience preferred - preferably in Medical Affairs or product development or is a recognized expert in the field or therapeutic area (with a minimum of 2 years’ clinical experience)
  • Considerable experience in the principles and techniques of data analysis, interpretation and clinical relevance, medical writing
  • Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.) preferred
  • Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development 
  • Considerable experience in the principles
  • Proven track record of meeting or exceeding objectives and goals