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Date Job Title Job Level Location
12/13/19 PV Clinical Associate Individual contributor South San Francisco, California

Summary of Position:

PV Clinical Associate performs the tactical 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 Associate leads clinical review of USDS cases (processed in-house or externally by vendor) and supports the US Drug Safety PV Clinical Manager - Associate in all activities. All responsibilities are performed under the direction of the PV Clinical Manager- Associate.

Key Accountabilities:
  • Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs)
    • Reviews, evaluates and verifies potential AE information during Preliminary Assessment (PA) to determine required action per internal policies and procedures and perform data entry of adverse event by timely completion of the case via Roche global safety database. Performs seriousness / validity / causality and conducts quality review of all cases (as applicable) based on their medical assessment
    • Performs labelling assessment for AE(s) received using clinical knowledge and conducts follow up for all reported cases (as applicable)

  • Responsible for Clinical Review of cases processed in-house and by vendors
    • Understands case processing data to evaluate error rates and potential compliance impact
    • Performs trend analysis of vendor case processing issues and escalates to vendor and USDS management
    • Responsible for developing executive summary on the quality trends observed on a quarterly basis
  • Responsible for training internal USDS and/or vendors staff or team in collaboration with SP PV oversight based on trend analysis
  • Responsible for ensuring appropriate data correction in the safety database for identified issues or errors
  • Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Clinical Associate/Vendor staff via communication module
    • Accountable for training internal and external staff members on using communication module
    • Performs daily reconciliation of outgoing communications
  • Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable)
  • Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners
  • Supports PV Clinical Specialists in tasks and projects as needed
  • Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
  • Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
  • Acts as single point of contact with key stakeholders for safety related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management
  • Responsible for the preparation and development of Drug Safety presentations and participates in the education of for internal /external stakeholders as applicable
  • Acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs
  • Provide support during audits and inspections
  • Collaborates with PV Operations and SP PV Oversight teams as needed

Competencies Identified for Success:

  • Demonstrates capability to comprehend medical information
  • Demonstrates ownership, initiative and accountability
  • Sound decision making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility
  • Demonstrates strong, dynamic leadership skills
  • 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 flex and thrive in an agile and fast changing environment
  • Strong attention-to-detail

Education, Experience, and Other Requirements:

  • Health Care Professional degree (Required)
  • Minimum 0-2 years of clinical experience (Required)
  • Writing experience; science/medical writing (Required)
  • Computer proficiency (Required)
  • Data entry experience (Preferred)
  • Able to travel as per business needs

CMG Operating Principles
External Link External Link OP
I put the patient first, always.

I am tenacious in meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive.

I build a culture of trust.

I grow my capabilities to increase my impact.

I have a bias for action.

I am accountable.

I use time and resources to create the most impact.

I act with integrity.
12/11/19 Quality Assurance Specialist III, Compliance Individual contributor Hillsboro, Oregon

Main Purpose of the Position:

  • Participate in activities to enable Inspection Readiness, including facilitation of internal/external audits and managing activities to support US/exUS filings and regulatory inspections.   This position will also include managing the process for identification and mitigation of site health authority compliance risks, management of emerging regulations (including drug product, medical device and combination product production) and systematic evaluation of new requirements, oversight for trending of Quality Compliance Performance, Supplier Management and acts as a Regulatory liaison. 

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Responsibilities:

  • Develop and execute inspection/audit prep plans and manage the inspection readiness activities (maintain key contact list, prep/strategy sessions, inspection readiness training, etc.)
    • Manage and maintain the Inspection Ready Room
    • Conduct post-inspection lessons learned sessions
    • Participate in cross site Inspection Readiness meetings
  • Manage and facilitate internal audits/assessments, partner audits and regulatory inspections for the site
    • Manage and provide oversight on the response process for audits and inspections
    • Escalate findings as appropriate 
    • Track inspection commitments to completion
    • Perform post inspection impact assessment of findings identified from other Roche sites 
  • Manage and provide oversight on the site self-inspection program
  • Manage the process for identifying and assessing compliance risks and track remediation activities/ action plans to closure
    • Conduct training for the Compliance Scoring Tool and Process
    • Maintain the site inspection risk log and publish the Inspection Readiness scorecard in accordance to the defined global schedule
  • Provide inputs to standard Quality reports, such as summaries for Annual Product Reviews
  • Support creation and maintenance of documents supporting Regulatory filings, such as Site Master Files, Regulatory Maps
  • Serve as the Compliance / Quality representative on cross-functional and multi-site teams
  • Work and lead collaboratively within the PT Network – on project teams, network meetings, cross site initiatives, participating in other site compliance activities (i.e. Site Self Inspections, Network projects, Summits).  Be able to represent HTO, but also Drug Products and other positions.
  • Train new personnel and internal customers on relevant business processes.
  • Interact with senior internal and external personnel on significant matters.
  • Represent organization as a prime contact on initiatives and projects.
  • Interface with supplier quality management team to ensure supplier compliance with cGMPS and applicable regulations
  • Maintain Quality Agreements in close collaboration with SMEs, QPLs, Contract Management group and business partners Quality and Service Level Agreements.
  • Support site programs and initiatives, such as Lead Production System and works to improve overall site capabilities

Qualifications I Requirements:

  • B.A. or B.S. degree (preferably in Life Science)
  • A minimum of 5 years’ experience in a Quality role in the pharmaceutical or biopharmaceutical industry; or an equivalent combination of education and experience
  • Highly self-motivated, and well organized; sound decision making skills
  • Ability to develop solutions to a variety of complex problems and initiatives
  • Ability to communicate clearly and professionally both in writing and verbally
  • Ability to interpret Quality standards for implementation
  • Sound knowledge of cGMPs or equivalent regulations
  • Flexibility in problem solving and work hours to meet business objectives

12/10/19 Marketing Manager Individual contributor South San Francisco, California

Marketing Manager

Key Responsibilities

  • Supports the development and execution of products value proposition, brand positioning and messaging, and the end-to-end customer experience.
  • Responsible for development and optimization of marketing materials and channel mix to reach target customers.
  • Demonstrates an ability to understand marketing strategy and develop materials or initiatives to deliver against a strategy
  • Uses and commissions appropriate marketing research needed to drive the product in the market and to inform the optimal end-to-end customer experience
  • Identifies and works regularly with network partners to deliver product marketing activities
  • Accountable for high quality, compliant execution across all marketing platforms and customer types (e.g. patients, providers, organized customers)
  • Prioritizes and creates personal messages and resources for field-based channels in coordination with non-personal messages and resources
  • Monitors marketing activity usage, performance, and customer satisfaction to optimize campaigns and drive customer and business outcomes
  • Partners with the Promotional Review Committee (PRC), including Legal and Regulatory, to ensure development, approval, and pull-through of compliant and effective promotional tactics
  • Leads and/or participates in flexibly deployed work teams across the CMG network, contributing novel ideas or approaches based on their areas of expertise
  • Works autonomously to make decisions and act, in close alignment with the full product value proposition, customer positioning, and Squad priorities

Skills and Competencies

  • Strong working knowledge of all aspects of brand marketing to include positioning, branding, campaign development and channel mix
  • Knowledge of the healthcare ecosystem including health economics, policy and the regulatory environment
  • Knowledge of each critical customer type e.g. patients, providers, organized customers as well as their experiences and their needs end-to-end
  • Ability to think with an enterprise mindset
  • Ability to influence and inspire individuals and teams across the CMG network
  • Breadth of experience in product/therapeutic area, access marketing and multichannel marketing
  • Ability to flex and thrive in an ambiguous environment undergoing transformational change
  • Strong customer orientation and focus
  • Strong analytical skills to effectively utilize research and behavioral data to shape strategies and tactics
  • Strong agency management skills
  • Ability to translate strategic direction into action plan for self, and make progress in the face of ambiguity
  • Good judgment in recognizing the distinction between "good enough" and perfection
  • Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities

Recommended candidate profile

  • Bachelors degree in Marketing / Business preferred
  • MBA or other related graduate level degree preferred
  • 7-10 years experience with the majority working in a product marketing function or relevant role
  • Experience in the managed care, pharmaceutical or biotech industry/pharmaceutical or biotech field sales
  • Marketing experience in other relevant industries
  • Experience in creating marketing strategies, plans and tactics that have strengthened market positioning and driven high-value customer and business outcomes

CMG Operating Principles

I put the patient first, always.

I am tenacious in meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive.

I build a culture of trust.

I grow my capabilities to increase my impact.

I have a bias for action.

I am accountable.

I use time and resources to create the most impact.

I act with integrity.

12/10/19 Global Project Manager, Product Development (South San Francisco) Individual contributor

Responsibilities:

  • Support molecule teams in the late stage portfolio.
  • Drive project and portfolio success by having an enterprise and portfolio mindset, being agile and managing ambiguity.
  • Enable senior stakeholders (Lifecycle Leaders, Disease/Franchise Heads, Therapeutic Area Heads and Late Stage Portfolio Committee) to make effective decisions.
  • Leverage trustful relationships with peers and stakeholders.
  • Play a pivotal communication role in ensuring awareness and alignment of project decisions and updates across the Lifecycle Team and senior leadership.
  • Transform insights into ideas and identify opportunities to accelerate project execution.
  • Proactively connect, align and guide teams on key decisions and execution.
  • Prioritize and focus team and individual efforts.
  • Deliver consistent and high quality project management services to enable team and project success by being strategic in project planning, team management and process management.
  • Actively participate in and make meaningful contributions to functional excellence and propose solutions, as needed, to improve the department.
  • Contribute to a teach-and-learn culture to support the success of others and the department.

Reporting Line:

This position reports directly into a Senior/Principal GPM or a Group Leader in the PPS-PM group.  

Qualifications:

Successful candidates will have a minimum of 7 years of relevant experience, including a minimum of 5 years supporting cross-functional teams in a scientific environment required.  They anticipate the needs of the project and proactively drive teams. They have the ability to embrace uncertainty and navigate teams through challenges, working independently to solve complex problems and managing change in a solution-oriented and flexible way.

  • Project management and/or leadership experience supporting/leading cross-functional teams in a scientific environment.
  • Drug development experience in the pharma/biotech industry.
  • Strategic and analytical thinking skills to assimilate complex information to inform decisions.
  • Leadership and influencing skills to be effective in a highly matrixed organization with geographically dispersed teams.
  • Use of interpersonal skills and influence to ensure team performance.
  • Display of leadership competency and presence.
  • Ability to contribute to functional initiatives and represent the department on cross-functional initiatives.
  • Excellent written and verbal English communication skills.
  • Travel internationally (up to 2-3 times per year).

Education:

Bachelor's degree required; advanced degree preferred.

12/10/19 Head of Quality Systems - Computer System Ownership Manager with direct reports South San Francisco, California

Position can be located in South San Francisco, Basel, Switzerland or Mississauga, Canada

Head of the QA Application ManagementJob Summary:

Defines, plans and/or coordinates activities involving the global implementation of modern Quality Computer systems (TrackWise, SAP, MES) used for QA business activities in the pharmaceutical industry to further global competitiveness, product quality and patient safety. Support Development, Implementation and Maintenance of the Quality IT Roadmap in support of the PT Roadmap and following PPM, Agile and PT IT portfolio processes. Provide leadership and guidance for quality oversight and support of computer systems used in the GMP environments to ensure compliance with Policies and Requirements. Drive continuous improvement through experimentation and innovation of systems that enable business process agility.

Key Responsibilities/Tasks:

  • Direct and participate in continuous improvement initiatives for Roche Global Computer Systems that support the Quality Assurance focused business processes

  • Demonstrate Lean Leadership Behaviors and drive continuing implementation of LPS
  • Identify, lead or participate in cross functional projects, process improvements or new system design/rollouts in support of functional or network goals and business needs
  • Develop strategies for new QA related IT System projects and for maintaining systems that are consistent with Roche policies, standards and procedures
  • Identify opportunities for enhancement of quality systems performance, usability and productivity through implementation and refinement of IT applications
  • Lead and partner with internal and external partners to understand IT System business needs, gap prioritization and delivery solution
  • Approve and oversee improvements to Quality operational policies, plans and procedures as systems are being optimized
  • Provide input and rationale for department budget.
  • Provide input for the development of overall Quality objectives and long-range goals
  • Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance
  • Manage and administer all aspects of people processes related to the employee life cycle.
  • Selection, hiring and training of personnel on company and department policies, systems and processes, goal setting, providing feedback).
  • Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. Provide guidance and coaching to teams on the topics of QA systems, Quality requirements and Master Data Management

Qualifications/Requirements:

  • B.S. or B.A. degree (preferably in Life Science)
  • 12+ years of relevant experience in the pharmaceutical or biopharmaceutical industry
  • Working knowledge of one or more informational packages (ie QMS, EDMS, MES, ERP)
  • Sound knowledge of cGMPs or equivalent regulations
  • Demonstrated knowledge and execution of Quality operations and processes
  • Experience in coaching, influencing (with or without authority) and motivating successful quality organization functions with demonstrated leadership in building successful collaborations with internal and external partners
  • Demonstrate use of LPS Lean Leadership Methods to drive continuous improvement
  • Demonstrate sound judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicate, influence and escalate issues and decisions as needed
  • Experience working in validated or controlled environments
  • Ability to interpret and relate Quality Policies and requirements for implementation and review
  • Ability to communicate clearly and professional both in writing and verbally

#L1-CGDL1

12/10/19 Senior Quality Control Associate I Individual contributor Hillsboro, Oregon

Responsibilities include performing technical and compliance laboratory related activities that support QC operations.  Manage and execute method transfers, method qualifications, equipment qualifications, data review, gap assessments, gap remediation, and discrepancy and out-of-specification investigations. Lead troubleshooting of assay failures and equipment issues. Collaborate with external groups to identify improvement opportunities in analytical technology and business processes.

Responsibilities:

  • Lead method transfers/method validations and prepare method transfer/validation protocols and summary reports
  • Function as HTO QC point of contact for analytical questions pertaining to assigned products
  • Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems
  • Plan and execute equipment qualification activities and generate, review, or approve equipment qualification/maintenance life cycle documents
  • Lead or participate in the identification, design and implementation of department and cross-functional initiatives and set personal performance goals
  • Identify and drive closure of gaps in systems and procedures
  • Identify, design, and implement process and system improvements
  • Manage and close discrepancies, lead and conduct out of specification/out of expectation/over limit investigations, and define and complete corrective actions preventive actions (CAPA), as needed
  • Identify and troubleshoot technical problems
  • Review data and assess against established acceptance criteria
  • Evaluate data to identify trends and/or establish limits
  • Perform technical review of peer-generated data
  • Support peer development by providing coaching and mentor ship
  • Lead or participate in multi functional teams/groups, projects, and process improvements
  • Provide and receive training and support development and administration of Quality Control training materials.
  • Support the maintenance and compliance of operational areas and apply GMP throughout all quality control operations
  • Support internal and external audits and regulatory inspections
  • Establish work priorities to meet targets and timelines; manage competing priorities
  • Serve as the Site QC representative/technical subject matter expert (SME) on cross-functional or multi-site teams and coordinate with customers to support multi-site operational activities
  • Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
  • Be accountable for behaviors as described in the Roche leadership commitments
  • Perform any other tasks as requested by Management to support Quality oversight activities

Qualifications: Education, Experience, Knowledge and Skills:

  • B.S./B.A. degree and seven plus years of experience or Master’s degree plus five years’ experience or an equivalent combination of education and experience.  Degrees are preferably in Chemistry, Biochemistry, Microbiology or relevant scientific discipline and experience is in pharmaceutical or bio pharmaceutical industry.
  • Sound knowledge of cGMPs or equivalent regulations
  • Technical proficiency in quality systems
  • Strong verbal and written communication skills, ability to organize and present information informal and formal group setting.
  • Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
  • Ability to make sound decisions about allocation of resources and managing priorities.
  • Ability to interpret and relate Quality standards for implementation and review.
  • Flexibility in problem solving, providing direction and work hours to meet business objectives.
  • Ability to troubleshoot instrumentation.

Work Environment/Physical Demands/Safety Considerations

  • Work in office and laboratory environment.
  • Lift up to 25lbs may be required.
  • Ability to sit, stand and move within work space for extended periods.
  • May be required to sit at a computer terminal for extended periods.
12/10/19 Senior Maintenance Mechanic, Process Utilities Individual contributor Oceanside, California

Summary:

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes. This is a Journeyman level position.

Responsibilities:

  • Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
  • Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
  • Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
  • Collaborate with department teams to complete specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
  • Provide general labor services throughout all areas maintained by the Maintenance department.
  • Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
  • Provide general expertise and training to junior staff.
  • Assist as technical SME with identification, purchase, and organization of spare parts.
  • Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
  • Cleaning and organization of designated work areas in Manufacturing and Utilities.
  • Complete GMP and other controlled documentation.
  • Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
  • Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
  • All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
  • Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Job Requirements

Education and Experience

  • High school graduate.
  • 7 years general maintenance experience and minimum 3 years in a cGMP environment.

     

Knowledge, Skills, and Abilities

  • Good communication skills, both written and oral.
  • Prompt, consistent and orderly work habits.
  • Ability to read and interpret P&ID drawings
  • Overall knowledge of mechanical, pneumatic, hydraulic, refrigeration, steam, electrical systems, controls, and maintenance methods. Specializing in at least one
  • General troubleshooting skills
  • Ability to work independently on all but complex or controversial issues.
  • Ability to interact well with others in a team environment.
  • Strong organizational skills and time management skills.
  • Ability to learn and use Microsoft based platforms and/or company Intranet and e-mail.
  • Ability to use computer software applications (MS Word/Excel).
  • Ability to use Building Management Control System (BMCS) and Manufacturing Control System (MCS)
  • Available to work overtime when necessary and work varying shifts, including an On-Call program.
  • General knowledge of shop tool operation and safety.

     

Work Environment/Physical Demands/Safety Considerations

  • Schedule may include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours.
  • Expected to be on feet for 8 to 10 hours a day.
  • Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
  • Climb heights up to 30 feet by ladder.
  • Lift up to 40lbs may be required.
  • Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make-up or jewelry can be worn when working in the clean room environment.
  • Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.
  • Work with electrical systems 480VAC and below
  • Work with hazardous materials and chemicals.
  • Work on pressurized gasses and liquids
  • Work on cryogenic systems
  • Work on steam systems
  • Wear air purifying respirator and wear necessary hearing protection.
  • Crawl, kneel and stoop and work in small work spaces.

#LI-PTJT1

12/10/19 Practice Group Leader, BioOnc Practice Group Associate Director/ Assistant General Counsel or Director/Associate General Counsel Healthcare Law Executive (Director/VP) South San Francisco, California

SUMMARY OF JOB RESPONSIBILITIES

The Practice Group Leader (PGL) leads the /BioOnc practice group, which is responsible for providing legal and regulatory counseling to the BioOnc Commercial Business Unit commercial and medical functions.   PGLs within the HLG may rotate into leadership of different HLG practice groups.  Responsibilities of the PGL include:

Practice Group and Personnel Management

  • Developing and driving a clear Practice Group vision and strategy and may assist in developing strategy for other practice groups or the broader Legal Department
  • Overseeing legal services provided by the practice group and helping ensure the consistency of legal advice related to FDA law and regulation, healthcare fraud and abuse, pharmacovigilance, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the commercialization of products
  • Overseeing workload and resource allocation for the practice group, and leading recruitment, hiring and on-boarding for direct report positions
  • Conducting performance management and professional development of attorneys and staff in the practice group, and contributing to same for attorneys and staff across the HLG and the broader Legal Department
  • Managing outside counsel providing advice and deliverables to HLG and, where applicable, negotiating rates, project fees, and timelines

HLG Leadership

  • Serving as a standing member of the Healthcare Law Leadership Team (HLLT) and owning and contributing to HLLT and HLG-wide and Legal department projects and initiatives
  • Contributing to the development and implementation of the HLG’s longer term strategies and annual goals
  • Contributing to the HLG talent management and  succession planning
  • Cultivating an HLG and broader Legal Department culture that reflects a strong commitment to employee engagement, diversity and inclusion

Business Support

  • Identifying proactively and seizing opportunities to create value and manage legal issues, fostering strong relationships with client groups, creating efficient and effective processes for working with clients, advising and/or delegating authority to advise senior leaders in the commercial and medical affairs organizations, and acting as a standing or ad hoc member of business or leadership teams
  • Participating in, leading, and/or presenting to various Company committees or other advisory, project or work teams 

REQUIREMENTS:

Candidates must have a JD with appropriate state license OR registered in-house counsel, 12 or more years of relevant practice experience, have at least 5 years serving as a strategic, trusted advisor to senior executives and have 3 or more years of experience as an effective manager of attorneys.

Required skills and experience include knowledge of and experience with US laws and regulations governing healthcare fraud and abuse, pharmacovigilance, GMP, advertising and labeling, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the commercialization of pharmaceutical products.

The successful candidate must have the demonstrated ability to build and maintain relationships, trust, and respect with clients and peers, as well as the ability to proactively identify and manage significant legal issues.  Strong leadership, technical knowledge, business acumen, and excellent communication skills are required as is a track record of effective, courageous, decision-making and the proven ability to assess, calibrate, and effectively communicate legal risk.  You must also have the ability to effectively:

  • Lead with a growth mindset and be able to inspire others to continuously learn and grow,
  • Display agility and focus on prioritization and improvement of systems and processes to enhance efficiency and productivity within Practice Group
  •  Leverage managerial courage required to counsel senior leaders and tackle difficult or challenging issues beyond the practice area,
  • Apply situational leadership to effectively lead a team of experienced attorneys, and coach and mentor personnel; and
  • Demonstrate the organizational savvy and diplomatic sensitivities necessary to  collaborate effectively with cross-functional client teams. 

12/10/19 Informatics Privacy Operations Support Expert Individual contributor South San Francisco, California

Scope:

Operational privacy support for legal entities/sites and business units/global functions 

Purpose:

Privacy Operations is a global supporting organization as part of Group Functions Informatics to support operational aspects of data privacy.  Main activity areas of Privacy Operations will be monitoring and executing processes related to CCPA compliance and privacy, coordination between all stakeholders; liaise with divisional and local operational groups, IT operations and / or eDiscovery for data retrieval tasks as well as keeping track of approval workflows.

Role in context:

The Privacy Operations will work closely together with the Global Privacy Office, covering operational and coordination aspects of processes related to data privacy and CCPA. Privacy Operations will be the interface between DPO and Information Security, Quality and Risk.

General Responsibilities:

The Privacy Operations Expert understands the overall objectives of CCPA and data privacy in general and specifically at Roche. He/she is able to interpret the Data Privacy Policy and underlying standards.  He/she will work closely with data privacy coordinators, local DPOs and operational groups throughout the divisions for all privacy related questions. This role ensures the timely execution of process workflows on a global level and supports them on a local or divisional level in order to meet all CCPA compliance targets.  

Specific Responsibilities

Operational responsibilities:

Support all processes related to CCPA and Data Privacy regulations compliance:

  • Support the Global DPO / Local DPO in the context of a Data Subject Access Requests and Data Breach, covering documentation and communication tasks

Manages global data subject access requests:

  • Identifies data scope (privacy register analysis)
  • Identifies, contacts and supports business data owners and IT solution owners
  • Coordinates data handling processes 
  • Liaises with original request recipients and internal supporting functions  
  • Close daily collaboration with the DPO Office
  • Documents and keeps track of requests acc. to CCPA requirements

Supports local data subject access requests:

  • Supports local / divisional data subject requests
  • Supports the local privacy organization (DPC, DPO) with process expertise
  • Monitors correct execution of processes
  • Monitors correct and complete documentation

Drive continuous improvement of the process and systems supporting CCPA

  • Initiate software improvement projects, and work with IT/Legal teams to design and implement process improvements.

Training responsibilities:

Contributes to training creation and maintenance by providing subject matter expertise and draft content related to privacy operations

Requirements:

  • Has a degree in Information Technology, ideally combined with data privacy/legal specialization

  • 3 to 5 years of experience as paralegal or legal IT specialist or eDiscovery expert

  • Has an in depth understanding of Data Privacy and CCPA

  • Has a strong sense of ownership for the Data Privacy Policy, standards and instructions issued by the global Data Protection Office

  • Self-disciplined and capable of identifying and completing critical tasks independently and with a sense of urgency.

  • Strong communication, problem solving and analytical skills required

  • Is able to execute accurately and pragmatically 

  • Is fluent in English, other languages are a plus

#LI-CGPK1

12/10/19 Healthcare Consultant Individual contributor Seoul

  • Job Description     

  • Establish a new RHC team with new ways of working together with your manager and colleagues
  • Define RHC services and positioning, foster internal and external promotion

  • Identify new consultancy projects together with Sales and other colleagues

  • Conduct expert consultancy to ensure delivery of optimal solutions and processes in and outside the lab

  • Identify customer needs and find possibilities for improvement

  • Summarize and share your findings in a comprehensive and attractive way

  • Where possible translate the benefits into financial benefits for the customer

  • Facilitate workshops with customers in an enthusiastic and highly energizing way, making sure the people of the team are all involved and contributing

  • Represent the company as reliable partner, develop and maintain enduring, value-driven relationships with stakeholders

  • Ensure a close working partnership with the customers and colleagues across departments

  • Engender a philosophy of teamwork, ensure horizontal and vertical information flow

  • Who You Are

  • You have a customer-centric, open mindset
  • You want to actively contribute in the formation and be part of a new, powerful RHC team
  • You strive to identify new consultancy opportunities to generate value for customers and Roche
  • You have a holistic view of Clinical/Medical Laboratories, their processes in and outside the lab and an understanding of the Korean Healthcare system
  • You have solid customer experience and knowledge about laboratory data and workflows
  • You are able to plan, execute and manage projects in a professional and timely manner
  • You have strong communication and presentation skills
  • You are able and willing to work cross-functional and with a variety of different stakeholders
  • You hold a University degree in preferably Life Sciences or relevant education

  • You are fluent in English language, both spoken and written

12/10/19 Marketing-Digital Solution Manager Team Leader Seoul

  • Job Description     

  • Create and articulate a vision that is centered on the patient
  • Embed and project this vision in all internal and external interactions
  • Actively drive our new digital strategy by closely collaborating with local, regional and global colleagues, as well as relevant external stakeholders
  • Identify and develop new opportunities
  • Generate new business models and pricing strategies
  • Market and competitor analyses for placement/rollout strategies
  • Evaluation of new digital solution
  • Launching and boosting of (new) digital/IT-solutions: clinical decision support SW like Viewics (support Navify?), RIS, Service intelligence (Remote CareGiver), uPath etc.
  • Internal marketing and promotion of team, services, business, focus areas etc. (messenger for the team)
  • Supporting RHC rollout
  • Close customer interaction
  • Build-Up of strategic partnerships
  • Training of internal and external customers incl. customer presentations
  • Drive cross-functional activities using agile methods and new approaches

  • Who You Are

  • You have a visionary, open and entrepreneurial mindset
  • You want to create new strategies and bring them to life
  • You are interested in new digital solutions, applications and their values
  • You have a holistic view of Clinical/Medical Laboratories and have an understanding of Healthcare System structure and functionality
  • You have solid customer experience and knowledge about laboratory data and workflows
  • You are able to plan and meet timelines, with moderate supervision
  • You have strong communication and presentation skills
  • You are able and willing to work cross-functional, beyond job descriptions
  • You hold a University degree in preferably Life Sciences or relevant education
  • You are fluent in English language, both spoken and written.
12/10/19 Alliance & Advocacy Relations, Associate Director Individual contributor South San Francisco, California

Position Overview/Job Responsibilities

Alliance and Advocacy Relations (AAR), a team within Genentech’s Government Affairs Department, is seeking a qualified Associate Director candidate to join our growing team. 

AAR  is responsible for leading the strategy and outreach of Genentech’s business interests as they relate to external healthcare-focused advocacy organizations. 

 

The successful candidate will develop, implement,  oversee, and evaluate engagement strategies, plans, and programs that enhance existing relationships with advocacy organizations relevant to Genentech’s BioOncology portfolio. This individual will focus on relationships to support Genentech’s priorities with pan-tumor patient advocacy organizations in the United States and lead cross-portfolio initiatives.  Cross-portfolio BioOncology AAR will include communications, charitable giving, advocate engagement at professional society and medical meetings, personalized healthcare and other business critical project strategies. He/she will be responsible for cultivating both internal and external relationships to address unmet patient and business needs.  

Associate Directors are leaders within Government Affairs’ AAR organization and engage with internal leaders across the company, including but not limited to, Commercial, Medical Affairs, Product Development, Early Research Teams, Regulatory and Corporate.

This is an exciting opportunity for an experienced individual working in the oncology space to lead a comprehensive advocacy engagement strategy and foster a network of highly-engaged patient advocates across the lifecycle of drug development.

 

This individual will work as a member of Genentech’s BioOncology AAR team and will report directly to the head of AAR for BioOncology.

This position location is flexible and can be based either in Genentech’s South San Francisco headquarters or the Washington D.C. office.  

 





 

Sample Job Duties and Accountabilities 

 

  • Expertly create, implement, and oversee execution against advocacy engagement annual and longer-range strategies, plans, programs and other tactics for the assigned disease area(s).

  • Serve as the primary point of accountability to develop long-term, trusting relationships with executive leadership of patient advocacy organizations in the United States

  • Maintain strong understanding and extensive knowledge of:

    • In-line brands and pipeline (examples could include CLL) patient advocacy communities

    • Scientific knowledge of GNE's Marketed and pipeline molecules

    • Key Issues, including relevant public policy, caregiver burden, disease awareness, early diagnosis and detection, and others

    • National, local and/or regional changes and trends in advocate organizations

  • Collaborate and lead team engagement on annual grants cycle by contributing to appropriate review processes

  • Represent Genentech at medical and patient meetings, conducting one on one meetings and larger briefings, as needed.

  • Inform and educate internal business partners regarding relevant advocates' current and future interests, needs, and other objectives, including associated implications from policy and legislative environment.

  • Support your/GA management and others in training, coaching, mentoring of team members and otherwise support work across the AAR portfolio, as needed.

  • Plan, implement and evaluate in-person and virtual learning events.

  • Work collaboratively with internal and external partners to ensure the patient voice is integrated into clinical priorities early and often

  •  Create strategies for effective engagement and communication on public policy, reimbursement and patient assistance programs

  • Create short-term and long-term strategies, objectives, programs and tactics for effective patient advocate engagement that meet the needs and priorities of the company and community and distinguish Genentech as a leader in the patient community

  • Deliver expertise and innovative approaches to the business to ensure the patient community is represented

  • Communicate timely and relevant information/knowledge sharing with key partners and stakeholders

  • Oversee, guide and evaluate multiple, concurrent advocate engagement programs and initiatives

  • Maintain broad scientific knowledge of GNE's marketed and pipeline oncology molecules

  • Identify key priorities of patient advocacy groups and develop novel partnerships to support cross-portfolio initiatives

  • Play a lead role in supporting the overall success of Government Affairs’ Advocacy Relations team

  • Support Head of BioOnc AAR in development and execution of BioOnc leadership initiatives

  • Attend outside meetings or events, as appropriate, to stay abreast of national, local and/or regional changes, trends of advocate organizations

  •    Ensure assigned goals and objectives are met and that assigned projects are completed on time, to high standards and within budget

  • Represent Genentech at key external meetings including medical and patient meetings

  • Lead projects or initiatives in the AAR department or within the wider Government Affairs organization, as needed.

  • Ensure assigned goals and objectives are met and that assigned projects are completed on time, to high standards and within budget.

  •  Inform and educate internal business partners regarding relevant advocates' current and future interests, needs and other objectives, including associated implications from policy and legislative environment

  • Represent Genentech's and Roche's focus areas to the highest ethical and professional standards and in accordance with guidelines, strategic, and key business direction.

 

Core Competencies

 

Qualified candidates should possess the following core competencies:

 

·      Technical and Business Expertise: Candidates should have a strong understanding of the pharmaceutical/biotechnology industry and healthcare environment, including trends impacting the patient community.  Qualified candidates should possess a deep understanding of patient advocacy organizations, including how organizations identify and prioritize engagement opportunities with industry.  Ideal candidates will have a strong internal and external network and be considered an influencer, demonstrable through considerable past achievements. He/she should be able to leverage relationships to extend or otherwise enhance opportunities.

·      Teamwork and Collaboration: Candidates should have the ability to develop and cultivate important and influential relationships with external advocacy groups and internal stakeholders, including Government Affairs, cross-functional partners, and leaders within Genentech’s BioOncology business unit.  He/she will work internally and externally to identify shared interests and opportunities between Genentech and key patient advocacy organizations. 

·      Achieving Results: Qualified candidates will have experience anticipating trends, identifying opportunities with internal and external stakeholders, and driving for positive results.  He/she will possess experience setting objectives and working with internal and external leaders, facilitating collaboration and creating successful engagement strategies.  He/she will demonstrate superior evidence of strong collaboration and partnering with internal and external stakeholders.

·      Communication: Candidates must have the ability to translate complex clinical, policy and access topics and issues and tailor the messages to a wide variety of audiences.  He/she will have the ability to create and edit written documents and oral presentations for internal and external groups. Candidates will possess experience and skill presenting to stakeholders at all levels.  He/she will have the ability to engage with individuals and groups to achieve alignment on key issues, actions and initiatives.

·      Inspiring and Influencing:  Candidates must have strong ability to use reasoning, persuasive arguments, personal credibility and knowledge of group dynamics to achieve a desired result. 

·      Strategic Agility:  Candidates must have a strong ability to translate vision into direction that adds distinct value to Genentech and builds competitive advantages.  He/she must have past experience leading strategic initiatives with large teams.

 

Qualifications:

  • Bachelor’s Degree required. Graduate Degree or higher in a related discipline is preferred.

 

Experience

  • Minimum of ten years post-college relevant healthcare experience. 

  • Four or more years’ experience in the pharmaceutical/biotechnology industry strongly preferred.

  • Experience working directly with or for a healthcare non-profit organization strongly preferred. 

  • Previous advocacy relations experience within a pharmaceutical/biotechnology company strongly preferred.  Other relationship-management expertise will be considered.

  • Existing relationships with national advocates who influence U.S. payer policies, legislation, regulations or practices is strongly preferred

  • Proven track record for consistently meeting or exceeding expectations, goals, objectives, etc. in past positions.

Skills and Ability

  • Outstanding influencing and negotiation skills, demonstrable through considerable past achievements.

  • Advanced understanding of the pharmaceutical, biotechnology or related industry; including general landscape, the marketplace, competitors, Genentech's products and points of differentiation

  • Applied understanding of how patient advocacy organizations operate, serve their constituents and engage with industry, demonstrable through previous experience.

  • Strong business and financial acumen necessary to build and integrate strategies, plans and goals.

  • Excellent partnering skills and evidence of success working collaboratively, effectively and efficiently with internal and external partners/stakeholders.

  • Experience creating, executing and evaluating strategy.

  • Experience in oncology or the ability to quickly learn the science of these disease states, related products, business and patient needs.

  • Outstanding communication skills, both written and verbal; including very good listening skills and an open attitude and acceptance to being coached

  • Management skills; ability to effectively delegate project work to internal staff, consultants and agency partners

  • Organizational skills including budget tracking, project management and planning expertise

  • Outstanding presentation skills

  • Strong organization, time management & self-management skills

  • Flexibility in working under tight deadlines and the continually changing priorities associated with policy and advocacy work

  • Ability to work without close supervision, while maintaining team approach

  • Excellent research and analytical skills

  • Business travel, by air or car, is required, up to or exceeding 60% of working time; including weekend and evening travel.

CMG Operating Principles

I put the patient first, always.

I am tenacious in meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive.

I build a culture of trust.

I grow my capabilities to increase my impact.

I have a bias for action.

I am accountable.

I use time and resources to create the most impact.

I act with integrity.

12/9/19 Intern - Research and Early Development - Clinical Pharmacology Entry Level South San Francisco, California

Length: 12 weeks

Start Date: Summer 2020

Our mission is to enable selection of a safe and effective dose, route and regimen for small molecules and biologics by applying the principles of quantitative pharmacology throughout a molecule’s life-cycle.  There are multiple internship positions in our department.

We are seeking an intern to identify strategies/decision-making used for dose-selection, to characterize drug-drug interactions, and to evaluate host determinants of drug toxicity. This individual will understand trial designs and recommend dose finding strategy to enable selection of a safe and effective dose, route and regimen for small molecules and biologics by applying the principles of quantitative pharmacology throughout a molecule’s life-cycle.

The activities would include a systematic review of FDA/BLA/NDA documents, scientific literature search, and gathering and summarizing the data collected.

Required Qualifications:

Familiarity with scientific research methodology. Introductory exposure to pharmacology, fundamentals of PK/PD, drug-drug interactions, and clinical trials are a plus. Good written and oral communication skills. Ability to work independently, with a scientific curiosity to explore beyond the obvious and perseverance to get the job done.

Education:

M.S. or Ph.D. or PharmD candidate in Pharmacometrics, Pharmaceutical Sciences, Biomedical Engineering or related discipline.

12/9/19 Internship for IT Service Desk Entry Level Petaling Jaya, Selangor

  • ​​​Responsibilities ·      

    • Assist in business functions in the areas of either IT on tasks related to your field of study.
    • Learn and practice basic day to day work or projects in a shared services environment.
    • Engage in networking with colleagues from other business functions and Senior Management on best work practices.
    • Discover within own team and/or with other process teams to identify and implement improvement opportunities.
    • Delivering high levels of customer service to both internal or external stakeholders.

    Requirement·      

    • Undergraduate students from reputable universities in relevant field of study.
    • Consistently achieved strong academic performance.
    • Available for a minimum period of 3 months.
    • Good command of spoken and written English & Mandarin.
12/9/19 Principal/Staff Scientist, Immunology Discovery Team Leader South San Francisco, California

The department of Immunology Discovery conducts basic and translational research to enable new target discovery and preclinical drug development for inflammatory, autoimmune, fibrotic, and retinal disorders. We have access to unique resources including rich genetic, metagenomic, biomarker, and clinical outcome data from thousands of patients in interventional and observational clinical studies; state-of-the-art laboratory facilities; and dedicated collaborative support from core research functions including genetics, bioinformatics, pathology, in vitro and in vivo model systems, pharmacology, medicinal chemistry, antibody and protein engineering, structural biology, and proteomics. 

We are seeking an outstanding established mid-career immunologist with a proven track record of leading original research as evidenced by significant conceptual and/or technical advances, high-profile publications, and mentorship of trainees. 

Job responsibilities

  • Direct a research lab investigating mechanisms of inflammatory human diseases such as (but not limited to) asthma, chronic obstructive pulmonary disease, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, idiopathic pulmonary fibrosis, systemic sclerosis, non-alcoholic steatohepatitis, type 1 diabetes mellitus, or inflammatory dermatoses.
  • Lead drug discovery teams from target identification through IND filing by working collaboratively with colleagues on assay development, in vivo animal models, pathology, bioinformatics, genetics, biomarker discovery, antibody engineering, small molecule drug discovery, pharmacology, and safety. 
  • Mentor junior scientists and postdocs in Immunology department.
  • Maintain/build presence in external research community through publications and speaking engagements at conferences/academic institutions.
  • Develop and lead cross-functional research and target discovery strategies for inflammatory disorders.

Qualifications

  • PhD, MD, MD/PhD, or equivalent in immunology, inflammation, or related discipline
  • At least 5 years’ experience as a PI/lab head at major academic or industry research institution; associate to full professor or equivalent
  • Proven track record of highly cited publications in high-impact journals
  • National/international recognition as leader or emerging leader in immunology/inflammation
  • Experience managing/mentoring personnel (students, postdocs, technicians) as demonstrated by successful career advancement of trainees
  • Experience researching topics including but not limited to: cytokine signaling, myeloid cell biology, lymphocyte biology, cell death, immune cell trafficking, host-microbiome interactions, resolution of inflammation, mechanisms of autoimmunity, neuroinflammation, systems biology, and/or related disciplines.

#LI-GREDGL1

12/9/19 Scientist, Immunology Discovery Individual contributor South San Francisco, California

The department of Immunology Discovery conducts basic and translational research to enable new target discovery and preclinical drug development for inflammatory, autoimmune, fibrotic, and retinal disorders. We have access to unique resources including rich genetic, metagenomic, biomarker, and clinical outcome data from thousands of patients in interventional and observational clinical studies; state-of-the-art laboratory facilities; and dedicated collaborative support from core research functions including genetics, bioinformatics, pathology, in vitro and in vivo model systems, pharmacology, medicinal chemistry, antibody and protein engineering, structural biology, and proteomics.

We are seeking an outstanding early-career immunologist with a proven track record of conducting original research as evidenced by significant conceptual and/or technical advances and high-profile publications.

Job responsibilities

  • Direct a research lab investigating mechanisms of inflammatory human diseases such as (but not limited to) asthma, chronic obstructive pulmonary disease, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, idiopathic pulmonary fibrosis, systemic sclerosis, non-alcoholic steatohepatitis, type 1 diabetes mellitus, or inflammatory dermatoses.
  • Lead drug discovery teams from target identification through IND filing by working collaboratively with colleagues on assay development, in vivo animal models, pathology, bioinformatics, genetics, biomarker discovery, antibody engineering, small molecule drug discovery, pharmacology, and safety.
  • Build presence in external research community through publications and speaking engagements at conferences/academic institutions.

Qualifications

  • PhD, MD, MD/PhD, or equivalent in immunology, inflammation, or related discipline
  • At least 2 years postdoctoral experience
  • Track record of first author publications in high-impact journals
  • Experience researching topics including but not limited to: cytokine signaling, myeloid cell biology, lymphocyte biology, cell death, immune cell trafficking, host-microbiome interactions, resolution of inflammation, mechanisms of autoimmunity, neuroinflammation, systems biology, and/or related disciplines.

#LI-GREDGL1

12/9/19 Scientific Manager, US Medical Affairs Biomarker Lead, BioOncology – Hematology and Solid Tumors Manager with direct reports South San Francisco, California

The Position

We are seeking two (2) dynamic translational research experts and scientific leaders to develop and execute on biomarker strategies for selected indications (hematological malignancies or solid tumors) in US Medical Affairs (USMA) BioOncology. As USMA Biomarker Lead, you will work cross functionally with internal and external stakeholders to shape and drive biomarker-related efforts supporting both pre- and post-marketed molecules. Primary accountabilities of this position will be to lead biomarker-driven evidence generation activities with the goal of translating science into meaningful benefit for patients and driving medical progress. You will have the opportunity to work at the forefront of personalized healthcare (PHC), precision oncology and reverse translational research.

This role requires an individual with outstanding communication and leadership skills to effectively bridge internal biomarker teams, matrixed medical teams and external US thought leaders or industry partners in a fast-paced research environment. The ideal candidate will be familiar with cutting edge biomarker discovery techniques, is knowledgeable in personalized healthcare/precision oncology and has experience in clinical trial design and conduct.

The position will report into the Oncology Biomarker Development (OBD) department within Genentech Research and Early Development (gRED) that is responsible for biomarker discovery and diagnostic assay development.

Primary responsibilities: 

  • Act as lead expert for disease-area biomarker strategies, diagnostic assays and cutting-edge translational research internally for USMA BioOncology, and externally for collaborators and investigators
  • Design, execute and monitor biomarker/diagnostic strategies, plans and tactics, including:
    • Develop translational research objectives, oversee biomarker data generation and lead biomarker analyses in clinical trials and scientific collaborations (including real-world data)
    • Closely collaborate with medical teams (including field teams), study management teams and data scientists/biostatisticians
    • Support product launches and label expansions from a biomarker perspective
    • Foster scientific exchange with thought leaders in translational research and medical oncology in collaboration with medical teams
    • Prepare scientific publications and presentations
    • Collaborate on biomarker-focused medical communication and education
  • Work with global disease area, molecule, personalized healthcare, diagnostic strategy teams and Roche/Genentech early research and development to stay abreast of internal developments and to inform/align strategies
  • Identify novel scientific/strategic biomarker opportunities in line with disease area, molecule and biomarker strategies

Qualifications:

  • PhD, MD or PhD/MD degree in a relevant scientific field (e.g. cancer biology, molecular oncology, cancer immunology, cancer genetics)
  • At least 5 years of relevant experience in an academic and/or industry setting
  • Strong scientific background in basic or translational research and significant drug development experience as evidenced by scientific publications
  • Significant drug development experience as evidenced by product launches, patents or filings are preferred
  • Ability to lead through lateral influence, excellent relationship management and strong negotiation skills
  • Excellent organizational and communication skills, both written and verbal, including presentation skills
  • The candidate should be highly self-motivated with a can-do attitude and demonstrated ability to think out of the box
12/9/19 Clinical Scientist Assistant/Associate, Rare Blood Disorders South San Francisco, California

GENERAL POSITION SUMMARY/ PURPOSE:

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Clinical Science Associate participates in development of the Clinical Development (CD) plan and supports the assigned PD Medical Director/Clinical Development Physician(s) with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s). PD Clinical Scientists have primary responsibilities for supporting PD Medical Directors/Clinical Development Physicians with clinical documentation, representing CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding CD studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting. PD Clinical Science Associates are expected to perform their responsibilities with more independence by comparison to PD Clinical Science Assistants, PD Clinical Science Associates are likely to have external interactions with cooperative groups, key opinion leaders (KOLs), external vendors supporting the work of CD, etc.

PRIMARY DUTIES AND RESPONSIBILITIES:

1. Cross-Functional Team Membership

  • Participates in the relevant Clinical Science Team (CST)
  • Represents CD in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s), except the Development Working Group (DWG). As needed and appropriate, addresses CD study or other program-specific questions; provides updates; delivers presentations; etc.
  • As requested, supports PD Medical Directors/Clinical Development Physicians with training new CST members

2. Global Clinical Development Planning

  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
  • Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
  • Supports PD Medical Directors/Clinical Development Physicians, as assigned, in developing and/or preparing clinical science information for inclusion into the CD strategy for the relevant therapeutic/disease area(s), annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
  • Contributes to the development of the CD plan for assigned molecule(s)/indication(s) and/or other programs
  • Gathers and analyzes data and information necessary to create the CD plan
  • Where applicable and assigned, supports PD Medical Directors/Clinical Development Physicians in providing other groups with information and input into budget/resource requirements necessary to implement and execute the CD plan
  • As assigned and appropriate, supports PD Medical Directors/Clinical Development Physicians in preparing for HA meeting

3. Clinical Development Plan Implementation

Provides clinical science support for assigned studies and programs:

  • Participates in ongoing CST and relevant sub-team meetings, other interactions and communications
  • Provides input on clinical study designs. Designs CD studies with guidance and oversight from PD Medical Directors/Clinical Development Physicians
  • Conducts appropriate literature searches
  • Collaborates with clinical operations, other groups and PD Medical Directors/Clinical Development Physicians to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc. Helps coordinate consistent use of language and criteria across multiple Roche teams and projects (includes partner studies)
  • Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed by other Roche groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
  • Helps coordinate the successful completion of documents with other groups
  • As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
  • May develop or provide input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with PD Medical Directors/Clinical Development Physicians (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
  • Collaborates with clinical operations to develop agendas, materials and other items for investigator and other relevant meetings pertaining to assigned studies and programs
  • As needed/appropriate, accompanies clinical operations staff to study site visits, investigator and other meetings
  • Provides additional support with site training, as needed, or requested
  • Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.
  • Responds to questions from other internal and external parties regarding assigned studies and programs
  • Collaborates with PD Medical Directors/Clinical Development Physicians, clinical operations, data management and other groups to conduct clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. Works with PD Medical Directors/Clinical Development Physicians, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries
  • Participates in safety meetings and tracks, analyzes, and reports any potential safety events
  • Reviews, analyzes and discusses clinical study reporting documents with PD Medical Directors/Clinical Development Physicians and various other groups
  • Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments
  • Supports PD Medical Directors/Clinical Development Physicians in preparing for internal/external meetings and presentations
  • Works closely with PD Medical Directors/Clinical Development Physicians, clinical operations, and other groups to close-out clinical studies, secure data and complete study reporting
  • Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
  • Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Coordinates submissions to scientific meetings and/or other appropriate venues or groups
  • Supports PD Medical Directors/Clinical Development Physicians, regulatory and other internal partners/stakeholders with completion and submission of regulatory filings and other regulatory documentation. Writes clinical science sections of HA meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
  • Supports PD Medical Directors/Clinical Development Physicians with ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs for the relevant therapeutic area of assignment
  • Completes and/or leads other special projects, as and when assigned, or otherwise requested
  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following 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.

QUALIFICATIONS & EXPERIENCE:

  • Bachelors Degree required (life sciences preferred)
  • Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
  • 5 or more years clinical trial experience (must demonstrate a minimum of 2 years clinical trial experience in pharma/biotech industry)
  • Data listing review experience is preferred
  • Experience authoring experimental protocols and/or study results and conclusions
  • Relevant therapeutic area experience
  • In-depth understanding of Phase II – III drug development
  • Experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Comprehensive understanding of product and safety profiles
  • Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)

ABILITIES:

  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
  • Outstanding attention-to-detail
  • Proven abilities to perform Clinical Scientist responsibilities with increasing expertise and independence. Has demonstrated, through past experience, abilities to competently manage the majority of Clinical Scientist deliverables associated with assigned clinical studies
  • Good business acumen; has working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
  • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
  • Good interpersonal, verbal communication and influencing skills; can influence without authority
  • Strong written communication skills
  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
  • Works well within teams and is effective in collaborating with others internally and externally
  • Ability to travel (<20%)
12/9/19 Scientist/Sr. Scientist, Toxicology South San Francisco, California

The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products. We are seeking a Scientist/Senior Scientist in Development Toxicology to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to small and large molecule programs.

Responsibilities:

The successful candidate for Scientist/Senior Scientist will provide scientific leadership and play an active role in the process of drug development from discovery through marketed products. Working in a collaborative team environment, the Scientist/Senior Scientist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity, strategic planning, and designing/implementing/supervising toxicology studies in support of program advancement.

Responsibilities include interdisciplinary project team membership, scientific leadership in the design and implementation of safety assessment strategies to support program advancement and decision-making, preparation and review of regulatory documentation, study reports and manuscripts, representation of Genentech in meetings with regulatory authorities, investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional internal and external collaborations are desired.

Qualifications:

  • A PhD and post-doctorate or equivalent experience in toxicology or a relevant field along with a minimum of 2-6 years of relevant experience in the pharmaceutical/biotechnology/CRO industry related to toxicology.
  • Immunology and/or cancer immunotherapy (i.e. gene and cell therapy) experience desirable.
  • Experience in drug development and interaction with global regulatory authorities.  
  • Board certification in toxicology is highly desirable.
  • The successful candidate must also demonstrate strong decision-making, complex problem solving, critical data analysis and interpretation, excellent written and verbal communication skills; and the ability to build productive cross-functional collaborations both within and external to Genentech
12/9/19 Scientific Researcher Development, Safety Assessment Individual contributor South San Francisco, California

A Scientific Researcher provides in vivo technical support for the pharmacokinetic, pharmacodynamic or toxicological assessment of drug candidates and marketed products in the department of Safety Assessment (SA).

Responsibilities:

The responsibilities for a Scientific Researcher include:

  • Work with minimal supervision executing studies of increased complexity, supporting all study types commonly employed by the team. 

  • May be asked to present data at project team and department meetings as appropriate.

  • Expected to assist in the accomplishment of departmental/team goals. 

  • Maintain documentation related to protocol execution

  • Adhere to departmental SOPs to ensure study integrity and quality

  • Abide by all animal welfare guidelines

  • Proactively provides lab maintenance and study preparatory support for the team as needed and performs other duties as assigned  

Role will involve:

  • Performing some repetitive tasks such as pipetting and labeling tubes

  • Performing techniques involving a high degree of manual dexterity

  • Adhering to Genentech personal protective equipment policy and lab compliance

  • A high level of physical activity

  • Sitting or standing for extended periods

  • A willingness to work flexible hours, weekends and holidays as necessary. Potential for Sunday-Thursday schedule. 

  • Work in a highly interactive team setting and as such the candidate must exhibit excellent collaborative skills within their team and with stakeholders

  • Work with potentially hazardous materials including (but not limited to): chemotherapeutics, radioisotopes, and infectious agents

Requirements:

  • BS in Biological Sciences (or related field) or relevant experience
  • Familiarity with Provantis a plus
  • 1-2 years of direct experience (within the past 12 months) with in vivo models required  
  • Demonstrates excellent communication and collaboration skills cross-functionally and within the immediate team

Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected].

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.