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Date Job Title Job Level Location
5/19/18 Senior Administrative Associate Individual contributor South San Francisco, California

Job Description: To provide timely, accurate, and effective administrative support to the Director of Early Clinical Development and his direct reports to contribute to the organizational and corporate goals.  Work to improve efficiency of administrative processes while providing high-level of customer service.

Roles and Responsibilities:

  • Maintain multiple complex calendars to include reducing conflicts and accommodating high priority commitments
  • Facilitate communications on behalf of the team ensuring key information is proved clearly, quickly and accurately at the appropriate time
  • Plan, schedule, and coordinate onsite/offsite meetings to include audio and video conferencing
  • Coordinate travel and conference attendance
  • Process Invoices, payments, and expense reports using standard corporate applications
  • Build and maintain strong collaborative partnerships.  Makes productive contributions, identifies concerns, gaps or opportunities and offers relevant recommendations and suggestions
  • Solve problems and make decisions within general parameters set by one’s managers
  • Exercise sound judgment and discretion of sensitive/confidential information
  • Maintain standard Development tracking tools utilizing computer and software applications
  • Highly skilled using Microsoft Office Suite
  • Participate in and support a variety of projects
  • Serve as a resource for the department staff and administrative teams
  • Provide back-up coverage for AP team members
  • Strong customer focus and team participation


Job Requirements:

  • A minimum of an AA degree and 4 years of administrative experience or transferable administrative skills or a High School Diploma and 7 years of administrative experience or transferable administrative skills. Support of project teams and biotech industry experiences a plus
  • Highly proficient with email, calendar, word-processing, spreadsheet, database and presentation applications; Microsoft Office suite required
  • Ability to quickly learn new skills and software applications
  • Very skilled in writing and interpersonal communications with some ability to persuade and influence to add value to end results
  • Ability to establish contacts outside of ones work group and functional organization and develop partnerships with others to improve efficiency
  • Ability to handle routine and impromptu assignments with minimal supervision
  • Strong organization and prioritization skills with ability to multi-task
5/19/18 Senior CS / GCP Auditor Individual contributor South San Francisco, California

We are looking for somebody who is familiar with the use of Computerized systems in clinical trials and safety reporting and  who also has the ability to connect systems with process, can identify a GXP non-compliance but also determine impact and communicate that impact to our stakeholders who are Business Process Owners, System Owners, study teams etc.

Forming part of a highly successful auditing team,  you can bring your expertise of GXP, Computer System Validation (CSV), Data Integrity and international regulations to the auditing processes associated with drug development.  We believe in developing the capabilities of our team and invest in cross training across the GXP’s and CS.

As part of your responsibilities, you will participate and also lead audits of Investigator Sites, GXP & IT processes, Affiliates and Service Providers. You will, where required, assist with preparations for, and participate in, regulatory authority inspections. You will also partner with cross functional teams  across the business to help develop a quality strategy that meet GXP compliance requirements.

Experience it for yourself.  Everyday your contribution will positively influence patient outcomes.

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You're searching for your next challenge in your pharmaceutical career, one where you are able to utilize your extensive experience of drug development processes and CSV regulations.  You’re a strong influencer and can negotiate the most complex issues towards effective solutions.

To succeed in this role, you are able to display initiative, have a high attention to detail and you are focused on securing results with determination to solve problems.  Your diplomacy and communication skills will also be needed in supporting the business and senior management within a cross functional, international environment.

Degree qualified in biomedical, scientific or IT discipline combined with strong industry experience within pharmaceutical or biotech clinical research, you ideally have CSV Quality Assurance auditing experience in an international environment.  Experience in GVP or GCP Quality Assurance auditing would be preferable but not essential.

Must be willing to travel domestically and  internationally on a frequent basis: 40% travel. CSV Auditing expertise.

5/19/18 Manager, Pipeline Portfolio Planning South San Francisco, California

Manager, Pipeline Portfolio Planning, Late Stage (E4)

Who We Are

At Roche, 82,000 people across 150 countries are pushing the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer, autoimmune & other serious illnesses.

Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work

The Position

Manager / Molecule Lead, Pipeline & Portfolio Planning (PPP)

The individual works closely in guiding lifecycle leaders and senior management in making critical product development and portfolio decisions by:

  • Advising life cycle leaders on significant development decisions and lifecycle plans
  • Partnering closely with Global Product Strategy (e.g. Lifecycle Leaders) and Product Development (e.g. Global Development Team Leader) for late stage projects to optimize value of a molecule
  • Performing business case assessments for development decisions, including valuation of various options to be considered by the lifecycle team
  • Providing context for decisions, both disease area and portfolio context, to help teams understand how decisions will be perceived by senior management / late-stage portfolio committee (LSPC)
  • Supporting Disease Area Strategy and lifecycle strategy projects, both in terms of ‘where to play’ decisions (e.g. market prioritization, product market selection) and ‘how to win’ decisions (e.g. clinical strategy, diagnostic strategy, access strategy)
  • Playing a critical role in broadly influencing product development and advancing treatments for oncology patients.

Responsibilities:

Representative responsibilities include:

  • Serve as an active core team member on multiple Lifecycle Teams (LCT) to support the development of externally competitive and internally aligned strategies
  • Advise on prioritization of development and strategic options with clear perspectives on strategic context, value proposition, key risks, contingency plans, and provide a formal recommendation 
  • Facilitate Life Cycle Teams engagement with the Late Stage Portfolio Committee by identifying critical business questions, framing the solutions, and simplifying the decision processes
  • Partner with early stage (gRED and pRED) PPP lead to develop understanding of Roche pipeline across all development stages.  Support g/pRED teams for timely and smooth asset transition from early to late stage.
  • Support external partnering opportunities
  • Represent PPP in leading cross-functional initiatives and processes, including executive presentations and strategy development

Who you are

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.

Requirements:

Skills/Knowledge Required

  • Ability to influence senior leaders on critical decisions
  • Experience successfully leading strategic initiatives
  • Ability to simplify decision-making via well-articulated frameworks
  • Ability to lead and facilitate cross functional teams
  • Knowledge of drug development and familiarity with industry economic benchmarks
  • Comfort with financial cash flows and valuation
  • Ability to innovate

Requirements

  • Advanced degree in science, engineering, business or a related field. Experience or background in Oncology, in particular Breast Cancer, is a plus.
  • 3-5 years of experience in biotech, pharmaceuticals or a related field in business related functions. Experience in strategic planning and analytics is strongly desirable.
  • Ideal candidate will have 1-3 years of experience in portfolio management, market planning, business development, management consulting, or investment banking– with demonstrated career progression in role.
  • Evidence of strong strategic thinking, communication, analytics/modeling, planning and organizational skills required. Interviews will include case studies.
5/19/18 Statistical Programmer Individual contributor Shanghai, Shanghai

Responsibility - Prepares SPA deliverables for clinical study team members across the Project. - SPA-DA: Uses statistical methodologies, interactive data visualization to explore and to analyze data, and to communicate findings. - Lead statistical programming activities at study level or part of clinical project including task assignment for SPA team members. - SPA-DA: Lead Analytics exploratory programming activities at the summarized information or integrated analysis within the molecule studies.  Provides technical solutions to a wide range of problems. - Able to assess, clarify and make suggestions to requirements, contribute to developing programming documentation with consistency, provide statistical programming solutions in conformance to appropriate standards. - Develops approaches to meet study and project requirements, selecting fit for purpose tools and methods. Specify, review and implement Analysis Datasets adhering to data standards. - SPA-DA: Develops approaches to meet Analytics exploratory analysis selecting fit for purpose visualization and methodology across molecule studies. - Able to identify opportunities to provide stakeholders with data interrogation / visualization capabilities with support. - Contributes to Risk Assessment of reporting objects. Responsible for accuracy and reliability of results by adhering to risk assessment and QC guidelines. Builds and monitors quality in every aspect of job activities. - SPA-DA: Assess the risk of the Analytics exploratory deliverable:  exploratory analysis outputs, tailored visualization. - Coordinates within Biometrics or other Stakeholders to negotiate reasonable timelines and scope. Monitors work for scope creep and manages expectations. Negotiates alternative timelines based on resourcing / priority constraints. - Contribute to cross-functional initiatives and working groups with a focus on statistical programming, data process and analysis reporting procedures. - SPA-DA: Additional focus on methodologies, visualizations and new types of data.

5/19/18 Senior Group Leader - Device Development Manager with direct reports South San Francisco, California

The Sr. Group Leader will be responsible for leading and developing a cross functional team of up to 8 direct reports.  The role directs the design, development and implementation of primary drug containers and new device delivery technologies to support project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech.

The position has leadership responsibility in assessment, selection and implementation of new combination product configurations and provides guidance and input to support engineering and scientific activities within Genentech’s device development programs, including interaction with cross-functional senior stakeholders. The role will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, develop innovative and implementable solutions to complex process design problems, takes initiative to expand on assignments and pursue new ideas, and focuses on the continuous improvement of our work in her/his team. The incumbent will work  independently and will provide guidance, coaching and training to direct reports and manage work activities of staff members. The work is reviewed with a focus on long-term perspectives, as the candidate exercises considerable latitude in determining objectives and approaches to assignments.

The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.  This objective will be accomplished by executing activities in the areas of:

Team Leadership:

  • Manage and administer all aspects of personnel performance and staff development for the group.
  • Select, hire, and train staff on company and department policies, systems, and processes.
  • Coach and develop staff by providing an environment that encourages ongoing personal and professional development.
  • Manage and ensure the setting of goals for the team and the staff, and provide regularly scheduled feedback throughout the year, including workload prioritization and balancing.

Device Engineering:

  • Component selection, assessment of container-device compatibility and container-drug compatibility, development of testing methods to assess container and deliver system quality and functionality for existing and new technologies.
  • Regularly interface with staff and leaders in Contract Manufacturing, Project Core Teams, Development, Early and Late Stage Pharmaceutical Development, Quality and Regulatory Affairs.
  • Regularly interact with external development partners and component suppliers.
  • Drive problem solving using state of the art tools such as DMAIC, DFFS, DOE, Modelization, Monte Carlo Simulation and Probabilistic Design.

Quality Systems Compliance:

  • Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
  • Use (and create and implement, if necessary) local Device Development procedures and templates ensuring alignment with current versions of PQS documents and best practices.
  • Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
  • Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
  • Ensure compliance of training to PQS and job-related requirements.

Design Control:

  • Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
  • Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
  • Participate in hazards analyses and design assessments and reviews.
  • Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations. 

Qualifications

The right candidate will possess the following skills and experience:

  • BS, MS, PhD or advanced degree in Engineering. Preference for Mechanical Engineering or the equivalent.
  • At least 12 years of experience in the industry and/or academia (including advanced studies) post bachelor’s degree.
  • Direct supervisory experience with the demonstrated ability to build and lead strong technical teams and develop technical staff.
  • Experience in DOE, problem solving and modelling using physical rules. 
  • Expertise in 6-sigma as a green or black belt and excellent understanding of statistics.
  • Expertise in development of elector-mechanical medical devices is preferred.
  • Working knowledge of manufacturing, quality control, preclinical and clinical development and regulatory issues pertaining to combination products is preferred.
  • Extensive application of relevant modeling, design controls and/or statistical analysis.  For example:
    • Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis, Probabilistic Design.
    • Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
    • Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
    • Six Sigma (Green/Black Belt): DMAIC and DFSS
  • Proven track record of working effectively in a matrix organization with cross-functional teams (e.g., device development, regulatory, clinical, quality, and program management) and experience working in a highly collaborative environment.
  • Excellent communication skills.
  • Experience working with external partners is highly desirable.
  • Highly organized and detail oriented.
  • Excellent leadership skills.

#LI-PTD-JM

5/18/18 Senior Scientific Researcher, Molecular Biology lab, Genentech Research Individual contributor South San Francisco, California

We are seeking a Senior Scientific Researcher in the Department of Molecular Biology to support the production and optimization of genetically-modified cellular models. This position will be within the newly-established Cell Engineering Lab, wherein she/he will facilitate the design, execution, and validation of cell line engineering projects initiated by researchers across Genentech -- with the ultimate goal of generating more effective in vitro/ex vivo disease models and novel contexts for functional genomic screening. The candidate is expected to work creatively and independently within an extremely dynamic, collaborative research environment.

5/18/18 Mfg/Sr. Mfg Technician - BioProcess (VV) Vacaville, California

Responsibilities:

Technician

? Follow 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 safe work practices

? Operate systems that clean and sterilize tanks and filtration systems.

? Prepare materials for the production process.

? Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)

? Escalate process issues as necessary to ensure resolution of issue

? Comply with cGMP, SOP and manufacturing documentation.

? Use automation to perform production and equipment operations.

? Provide support to Manufacturing to meet production demands.

? Assemble and prepare equipment for production.

? Communicate effectively and professionally work in a team environment.

Senior Technician   – All technician responsibilities, plus…

? Be able to perform all routine operations

? Train other technicians in group and individual settings

? Troubleshoot process equipment and systems

Qualifications:

Education and Experience

? AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering

? Or combination of college coursework and related work experience

? Or Biotech certificate from approved program

Knowledge, Skills, and Abilities:

? Strong oral and written communication skills.

? Familiarity of computer-based systems

? Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.

? Ability to read and understand engineering documents is desirable

? Experience in creation and revision of Standard Operating Procedures and experience working in a Biotech Manufacturing GMP environment.

Must be able work weekends, off-shifts, and overtime as required.

? No make-up or jewelry can be worn when working in the clean room environment.

? Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam,

water, air and cleaning/sanitizing chemicals systems.

? Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift.

? Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.

? Handle and work with hazardous materials and chemicals per OSHA guidelines.

? Usage of hearing protection and dust masks may be required.

? Expected to be on feet standing or walking for up to 90% of shift.

? Travel up to 30 flights of stairs each shift to maneuver within the facility.

? Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online

computer systems.

? Lift up to 40lb loads multiple times per shift and carry up to 30 lbs. Team lifting will be used for heavier or awkward lifts/carries up

to 20 times per shift.

? Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force

limit up to 10 times per shift.

? Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand

motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces

must be exerted. Forces should not exceed 22 pounds.

? In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure <140/90, Vision must be at least

5/18/18 Mfg/Sr Mfg Technician - BioProcess ( VV) Vacaville, California

Responsibilities:

Technician

? Follow 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 safe work practices

? Operate systems that clean and sterilize tanks and filtration systems.

? Prepare materials for the production process.

? Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)

? Escalate process issues as necessary to ensure resolution of issue

? Comply with cGMP, SOP and manufacturing documentation.

? Use automation to perform production and equipment operations.

? Provide support to Manufacturing to meet production demands.

? Assemble and prepare equipment for production.

? Communicate effectively and professionally work in a team environment.

Senior Technician   – All technician responsibilities, plus…

? Be able to perform all routine operations

? Train other technicians in group and individual settings

? Troubleshoot process equipment and systems

Qualifications:

Education and Experience

? AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering

? Or combination of college coursework and related work experience

? Or Biotech certificate from approved program

Knowledge, Skills, and Abilities:

? Strong oral and written communication skills.

? Familiarity of computer-based systems

? Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.

? Ability to read and understand engineering documents is desirable

? Experience in creation and revision of Standard Operating Procedures and experience working in a Biotech Manufacturing GMP environment.

Must be able work weekends, off-shifts, and overtime as required.

? No make-up or jewelry can be worn when working in the clean room environment.

? Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam,

water, air and cleaning/sanitizing chemicals systems.

? Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift.

? Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.

? Handle and work with hazardous materials and chemicals per OSHA guidelines.

? Usage of hearing protection and dust masks may be required.

? Expected to be on feet standing or walking for up to 90% of shift.

? Travel up to 30 flights of stairs each shift to maneuver within the facility.

? Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online

computer systems.

? Lift up to 40lb loads multiple times per shift and carry up to 30 lbs. Team lifting will be used for heavier or awkward lifts/carries up

to 20 times per shift.

? Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force

limit up to 10 times per shift.

? Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand

motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces

must be exerted. Forces should not exceed 22 pounds.

? In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure <140/90, Vision must be at least

5/18/18 Regional Scientific Affairs Manager - Cardiac (Remote) Manager with direct reports USA - Field, California

Ideal candidate lives in east-mid US

Job facts:

Lead and develop the Medical & Scientific Liaisons in their relationships with the medical/scientific community, with the objective of critical scientific exchange including medical/scientific education and responses to unsolicited “off label” inquiries to support healthcare professionals as well as internal Roche scientific groups and local business teams.

Specialized and in-depth comprehensive knowledge and experience in a particular field, or business area. Duties are varied and complex often involving research, analysis and solution development. Provides direction on issues of area of expertise and assist department leadership in setting strategic direction. Typically a higher level professional position. Requires the regular use of originality and ingenuity. Possesses and applies a broad knowledge of principles, practices and procedures of field. Is generally assigned more complex and difficult assignments. Assignments are broad in nature. Typically works with greater discretion and latitude. May assist Consultants and lower level staff by providing advice and guidance.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

The Opportunity:

  • The Regional Scientific Affairs Manager will:
  • Maintains all of the Medical & Scientific Liaisons (MSL) responsibilities and competencies in the MSL job description. Additionally, assists with strategic customer engagements and thought leaders activities
  • Assists with recruiting, hiring, training and maintaining highly skilled field-based MSL. Provides direction, coaching and development of MSLs. Engages in direct observation and assessment of assigned MSLs on at least a quarterly basis. Provides verbal and written feedback on performance. Assists with establishment of and progress toward individual Objectives for assigned MSLs.
  • Assists with identification of educational needs and opportunities for MSLs. Assists with coordinating MSL attendance at appropriate scientific meetings.
  • Facilitates and develops the relationship with the medical/scientific community, by communicating product- related information to investigators and institutions. Provides information on research developments and new concepts in medical treatment and scientific technology, giving perspective to field activities associated with growing existing products and bringing new products to market.
  • Skilled in offering high level technical support to customers, sales and marketing. Addresses customer’s scientific inquiries (on-label and off-label unsolicited requests), documents requests and actions, troubleshoots issues and customer applications at site.
  • Disseminates project information/customer interaction. Attends appropriate U.S. and international scientific congresses, develops in-depth understanding of clinical practices and regulations, and maintains understanding and insight into current lab and clinical practices and guidelines.
  • Assists Director in regular staff meetings and other group activities and functions.
  • Accountable for identifying, collecting, and holding accountable the KPIs and metrics.
  • Nationwide travel of 50-60% within assigned MSL territories

Who you are:

  • To be successful you will hold a Master’s Degree in Nursing, Business, etc
  • Previous management experience
  • 5+ years previous related clinical/practice experience
  • Ability to develop and maintain collegial relationships predominantly with specialists and generalists within respective fields, as well as nurses and laboratory professionals
  • Ability to lead, direct, influence and empower multi-discipline teams and individuals
  • Ability to successfully interface with senior management (within and external to company)
  • Capacity to manage conflict
  • Excellent oral and written communication skills
  • Ability to prioritize work and manage multiple projects and assignments simultaneously
  • Strong analytical and problem solving skills; Strong judgment and decision making skills
  • Ability to think strategically
  • Ability to develop and maintain deep relationships with thought leaders and healthcare professionals
  • Ability to quantify metrics


Preferred Skills:

  • Doctorate level education (MD, PhD, PharmD)
  • Knowledge of Roche Diagnostics products.

5/18/18 Vice President, BioOncology US Medical Affairs Executive (Director/VP) South San Francisco, California

The primary purpose of the role is to lead a complex organization, providing strategic medical and scientific leadership for all BioOncology Medical Affairs activities in the US, whose ultimate purpose is to optimize stakeholder confidence (e.g. HCPs, payers, patients, regulators) in the understanding and use of our evidence, resulting in the right patients receiving the right products at the right time. A candidate for this role will be a strong and collaborative servant-leader, deeply interested in the science of oncology and the clinical profile of our current and pipeline molecules.  The Therapeutic Area (TA) Head of BioOncology Medical Affairs will report to the Head US Medical Affairs (USMA) and will be a member of the Medical Affairs Leadership Team (MLT).

Key Accountabilities and Responsibilities:

  • Develop current and future Leaders: Deepen leadership capability in the organization in line with the needs of the USMA strategy.  Focus on being a visionary, coach, catalyst, & architect.

  • Facilitate the development of world-class strategy through integrated U.S. medical plans (including alignment with global medical plans) that generate and report/exchange clinical and other relevant data pertaining to the appropriate utilization of our cancer medicines including:

    • Ongoing safety surveillance

    • Pre-approval access - Phase I, II and III Investigator Sponsored Trials

    • Genentech/Roche sponsored trials

    • Post marketing clinical commitments

    • Registries

  • Establish the Benchmarks for Post-Marketing Methodologies: Together with specialized USMA functions, establish and support standards for a broad spectrum of oncology post marketing activities including product/medical education, publications, medical communication, and advisory

  • Serve as a Cross-Functional Leader: Actively participate and contribute to key organizational leadership teams, both standing as well as ad hoc. Interact with a broad range of Genentech and Roche functions, including but not limited to, Product Development, the Commercial organization (Marketing, Managed Care, Government Affairs), Business Development, Global Product Strategy (Lifecycle teams), Global Medical Affairs, Manufacturing, Research (gRED, pRED), Regulatory Affairs, Legal/Healthcare Compliance and other teams

  • Focus on Compliance: Work closely with other USMA and Global Medical Affairs functions (Medical Communications, Biometrics, Clinical Operations, Health Outcomes, Publications) to ensure that the appropriate data is communicated in a compliant fashion with key stakeholders, which may include payers, competent guideline writing bodies and academic conferences such as ASCO, AACR, SABCS; work in a cross-functional/matrix environment to support the compliant business needs of those Functions

  • Innovate: Participate on cross-functional teams for evaluation of innovative technologies and products in support of both clinical and commercial franchise strategies

  • Be the Face of BioOncology Medical Affairs: Interact with Genentech senior management, outside experts, corporate partners, investor relations, NCI/CTEP and, when relevant, the FDA. - Assess Competition and oversee medical  Launches: Provide input into competitor challenges including strategic input to prepare for new competitor launches

  • May serve as medical partner for an integrated product or disease area “Squad”


 

Key Competencies:

  • Strategic Agility: Strong ability to translate vision into a direction that adds distinct value to Genentech and builds competitive advantage

  • Building and Leading Teams: Excellent ability to lead and advance effective team performance across the business

  • Business Knowledge: Superior ability to integrate functional knowledge of BioOncology Medical Affairs and Oncology therapeutic area with a broader business perspective and appreciation for our markets and the overall biotech industry

Qualifications:

  • Be medically qualified (MD) with an area of advanced oncology specialization

  • Five plus years of pharmaceutical experience

  • Significant leadership experience, with a successful track record of managing a diverse group of employees

  • Diverse drug development experience spanning all phases of research

  • A successful track record of collaborating, leading and influencing outcomes in complex organizations and projects

  • Critical analytical skills and show an understanding of the broader challenges faced by our industry with an ability to liaise effectively, representing complex situations and concepts in digestible elements

  • High level of proficiency in interpersonal interactions, negotiation/influencing skills, presentational and communication skills

  • Sophisticated understanding of the evolving regulatory, medical practice and economic environments impacting Roche/Genentech both globally and within the US; in particular have a thorough understanding of US regulatory/FDA requirements

  • Substantive understanding and exposure to corporate legal and compliance groups, and be knowledgeable of issues related to, GCP, OIG and other guiding or controlling elements of our business

  • Track record of significant successful interactions with oncology key opinion leaders/investigators including a well established network

  • Demonstrated ability to positively and strategically influence employees at all levels and an accomplished record of leading cross-functional teams in a matrix organization

  • Demonstrated ability to mentor and develop emerging leaders

5/18/18 Records and Technology Manager Manager with direct reports South San Francisco, California

Seeking technology professional with enterprise-wide focus on electronic records management. This individual will lead complex, cross-functional work related to information management and make decisions that consider both business and technical needs. 

Key Responsibilities:

  • Developing strategies to drive the application of records management principles to electronically stored information so that electronic records are reliable, available, and usable throughout their lifecycle
  • Innovating approaches to help users find and access electronic information while balancing legal and business risk
  • Advising employees about electronic records management and acting as primary contact for electronic records related questions from employees and IT
  • Setting and managing KPIs related to electronic records management
  • Partnering with global records management colleagues to develop tools and processes to support the business in managing electronic records
  • Establishing records management requirements for systems that store electronic records, including requirements for decommissioning, and partnering with global IT teams to ensure requirements are satisfied
  • Overseeing employee training and communications that support electronic records management strategies and goals
  • Assessing new technology against records management and eDiscovery requirements
  • Acting as Genentech business solution owner for FileNet, FileTrail and scanners, including liaising with IT and vendors for any support, and drafting and reviewing documentation for validated systems, etc.
  • Overseeing the lifecycle of records management applications and eDiscovery tools to decide topics such as when to upgrade and when to decommission
  • Writing and maintaining descriptions of systems that are sources of data subject to eDiscovery
  • Serving as the Technical Lead for eDiscovery tool evaluations
  • Leading and directly managing direct report(s)

Who You Are

Ideal Experience/Education:

  • Bachelor’s degree required (advanced degree preferred)
  • Degree in information science, computer science or information technology preferred
  • 10 or more years of relevant work experience in information science or information technology required
  • Experience with machine learning, data classification, and information retrieval approaches preferred
  • Experienced user of enterprise content/records management software such as FileTrail, and FileNet, as well as the records management functionality in Google and Microsoft Office applications
  • Experience in a role with responsibility for developing strategy required
  • Experience in a corporation/regulated industry preferred

Critical Competencies:

Experienced Business Advisor:

  • Proven ability to deliver sound, clear, practical advice in a business setting
  • Excellent judgment and interpersonal skills
  • Ability to understand emerging technology and trends
  • Ability to gather business requirements and communicate them to technology partners

Influential Communicator:

  • Outstanding communication skills, both verbal and written
  • Superior client-relations skills
  • Ability to influence and collaborate with other employees, business partners, and IT
  • Business presentation experience, including experience presenting to more senior leaders
  • Strong influencing skills: proven track record and experience building and cultivating relationships with key partners and stakeholders across organizational levels 

Adaptive and Results-Oriented Performer:

  • Ability to multi-task with ease
  • Ability to support multiple, complex matters and projects at the same time
  • Ability to work both in a team and independently
  • Project management experience preferred
  • Fast-paced, yet detail oriented

Technology and Information Expert:

  • Ability to work with IT to understand new technology and determine ways to meet business needs
  • Ability to convey requirements to IT and influence solutions
  • Ability to develop information classification schemes and procedures
  • Knowledge of ways to protect key electronic information
  • Ability to identify impact of implementing new technology on information management strategy

Leadership:

  • Demonstrated skills managing and developing employees
  • A visionary who inspires reports and colleagues and who can influence stakeholders

Travel: Limited national and international

5/18/18 Associate Program Manager Regulatory Individual contributor South San Francisco, California

1. Intact & Cross-Functional Teams

  • Participates in site, regional and/or global PDR Program Management departmental meetings
  • Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
  • As assigned or otherwise needed, assists relevant Regulatory Program Directors with their interactions, communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams.
  • Helps Regulatory Program Directors coordinate cross-functional PDR contributions to product development projects and other related activities
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

2. Regulatory Program Management

  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects.
  • Expected to develop and maintain his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Briefs teams and management, as appropriate
  • Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
  • Stays abreast of therapeutic area product development and other related business strategies and plans
  • Supports on one or more regional projects at any one point in time
  • Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
  • Supports Regulatory Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
  • Supports Regulatory Program Directors and others in scheduling and preparing for meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
  • Documents meetings, teleconferences and other interactions/communications with regulatory authorities
  • Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority interactions
  • Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory deliverables, compliance, timing and other relevant matters. Helps manage RAFT resources, including documenting meeting minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
  • Helps manage project plans and timelines for assigned projects
  • As assigned, performs literature searches, prepares special reports and assembles documentation to support project teams
  • Supports Regulatory Program Management Program Directors with a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation.
  • Helps ensure that all elements, quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations and Roche standards
  • Supports effective, best-practice maintenance of various clinical and non-clinical regulatory documents
  • Helps Regulatory Program Management Program Directors manage all PDR deliverables associated with each project or other assignment to ensure these are completed within defined timelines and meet regulatory and other company guidelines
  • Participates in and supports development of regulatory risk management and contingency plans. Develops associated communication plans for Regulatory Program Management Program Directors and their internal distribution
  • Supports management of relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
  • As requested or otherwise appropriate, supports Regulatory Program Management Program Directors in providing regulatory due diligence assessments in cooperation with other internal groups

3. Other

  • Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Program Management-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools
  • Completes other routine and ad hoc analysis and reporting.
  • Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
  • May participate in other special projects, as and when assigned, or otherwise requested
  • Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements.
  • Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
  • Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines
5/18/18 Global Franchise Head - Ophthalmology Executive (Director/VP) South San Francisco, California

Primary Responsibilities and Accountabilities

  • Accountable for ensuring regulatory resource and budget support is provided for projects for designated franchise
  • Accountable for achieving global regulatory alignment on projects in the designated disease area and disease area regulatory strategy for the late stage franchise portfolio with input from partners
  • Accountable for development and implementation of overall regulatory strategy at franchise level and influencing internal and external key stakeholders
  • Responsible for providing regulatory leadership to decisions specific to the designated franchise
  • Line management responsibilities in the designated franchise. Provide high level strategic regulatory direction and mentorship and drives a culture of excellence and motivates employees to perform at their highest ability
  • Ensure that regulatory strategic options, assessments and risks are communicated to the business and key franchise decisions are cascaded within the PDR function
  • Responsible for providing regulatory expertise and designated disease area expertise for early stage project decisions through consultation
  • Build partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources
  • Ensure the Global Heads and other appropriate personnel across the organization globally are fully informed of key regulatory activities & issues related to the particular franchise area
  • Awareness & application of global regulatory environment within designated disease area (e.g. HA guidance, new approvals, competitor intelligence)
  • Lead special regulatory projects/process initiatives of high complexity, ensuring global alignment
  • Proactively manage critical issues, taking leadership for the regulatory contribution
  • Within the TA, influences policies, guidance development and represents the company at key external meetings
  • Serves as part of TA leadership team, management and contribution to peer reviews and other relevant committees and acts as a delegate for Global TA Head at DTA, DRC meetings etc. as required
5/18/18 Data Integration Specialist Individual contributor Basel, Basel-City

Rapid technological advances (e.g. next generation sequencing technology, electronic medical records) are resulting in a dramatic increase in the volume and diversity of scientific data (clinical, RWD, genomics) that is being generated both internally and externally.  This data is key to understanding disease subtypes, and drug response of patients within certain molecular subgroups, allowing us to develop new medicines and companion diagnostic tests more effectively and efficiently. 

The Enhanced Data and Insights Sharing (EDIS) initiative is a key enabler of PHC 2.0, accelerating learning and insights generation across Research and Development. A key capability which we have identified as being critical to the success of EDIS is the integration and sharing of biomedical patient data across the organization. This capability requires the creation of a new Data Integrator role within Pharma Development Biometrics.

Data Integrators are skilled data scientists who are able to both understand and manipulate highly complex clinical and high dimensional biomarker data sets (e.g., genotyping and gene expression data) in order to create analysis ready merged datasets as needed from a variety of data types (e.g. clinical trials, molecules or indications). The Data Integration Specialist is responsible for leading and executing data integration solutions in support of multiple programs within a disease area and across disease area projects. The main responsibilities will include:

  • Lead, design, develop, execute and deliver the optimal high quality data integration  solutions needed for clinical trial and biomarker data exploration to support successful strategic decision making for clinical development pipeline and better understanding of disease and drug response
  • Understand and meet partners’ data integration needs and offer solutions
  • Build and maintain strong collaborative relationships and effective partnerships with project teams as well as other communities, working groups, initiatives and external stakeholders, in close collaboration with molecule project teams and any other relevant technical groups and identify and prepare integrated data for analysis by quantitative scientists
  • Create, maintain and deliver a concise description of data preparation to partners and stakeholders as appropriate
  • In close collaboration with Data Curators , ensure that integrated analysis datasets are readily and broadly made available
  • Proactively raise ideas, develop fit to purpose prototypes, identify opportunities or gaps and promote knowledge sharings to enhance ways of working (including processes, methods, technology, project management, stakeholder management etc.) to support the vision for promoting advanced data integration solutions required for better data exploration and insight generation in relevant analytical groups

The minimum requirements are:

  • Knowledge of drug development (e.g. clinical development, Personalized Health Care) and clinical data models (SDTM, ADaM)
  • Curiosity and interest in the scientific aspects of drug development projects and advanced technology in data integration, analytics and visualization
  • Able to build strong working relationships with appropriate personnel in other functional groups within and outside of the Biometrics organization as well as strong problem solving skills and attention to detail
  • Demonstrated ability to rapidly adapt to changing project and strategic requirements with a proven ability to understand and become familiar with therapeutic and diverse disease areas, ability to work in unstructured and ambiguous situations
  • BSc. or M.Sc. or experience (no Phd)  in Data Science or computational biology related field (e.g. Statistical Programming, Statistics, Bioinformatics)
  • Programming experience to manipulate complex data sets, for example with SAS, R and/or other analytical software packages
  • Experience with using SQL and relational databases
  • Good knowledge of English in a business environment

Working location: Basel, San Francisco or Welwyn (UK)

5/18/18 Senior Medical Science Director Manager without direct reports South San Francisco, California

Director/ Medical Science Director Immunology (Respiratory)

Function

U.S. Medical Affairs

Job Family

Medical Directors/Medical Science Directors

Location

South San Francisco

Reports To

Senior Medical Director

Key Accountabilities

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

  • Making important contributions to pre-launch, launch and post-marketing medical strategies and plans; participating in and contributing to therapeutic area planning and reviews
  • Demonstrating increasing independence, working with less guidance and supervision, in strategizing, designing and executing clinical trials, other clinical studies and investigations, and other medical programs and related activities
  • Participating in and contributing medical affairs insights into Lifecycle Management and Lifecycle Plans, 3-year and 1-year brand and tactical plans, and other appropriate activities for assigned molecules/products
  • When assigned, acting as the Medical Team Leader for cross-functional medical affairs teams and/or as the lead Medical Affairs representative on cross-functional medical affairs teams or other core or sub-teams
  • Accomplishing the majority of your work with minimal supervision
  • Acting as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions
  • Compliantly engaging in partnerships with thought leaders and other external stakeholders to gain insights on medical affairs plans and activities
  • Managing your projects and other deliverables to ensure goals and objectives will be met or exceeded

Example Responsibilities

In this position, you will:

  • Medical Plan Development:

When assigned to the Medical Team for assigned molecules/products:

Contribute to or organize the work of assigned team(s) to include strategy development, implementation and oversight of execution

Guide assigned teams throughout all intervals to ensure strategies, plans, goals, objectives and targets will be met or exceeded

Play a lead role in providing medical input into assigned disease area's commercial strategy

Develop the Medical Plan for assigned molecules/products

Act as a standing or ad hoc member of development and/or commercial core and/or sub-teams as well as Global Medical Affairs teams

Represent U.S. Medical Affairs to ensure alignment of the medical strategy with the Lifecycle Plan and other business strategies and plans for each assigned molecule/product

  • Clinical Studies:

Work with MSLs and others to develop strategies, plans and programs for Phase IV clinical trials and other post-marketing medical investigations or studies

Where assigned, participate in development of designs and protocols for clinical trials, other studies and investigations

Where assigned, support others in developing clinical components of presentations at meetings with clinical trial investigators, study site clinical research staff, etc.

Support MSLs and others in implementing trials, other studies and investigations in the field

Where applicable, guide others on patient registry design, development and implementation. Includes strategies and plans for registry recruitment and retention

Contribute and provide medical input on relevant medical communications, publications, health economics and outcomes research, data management, documentation and database requirements to support clinical trials, studies and investigations

Measure study progress, monitor variances and to proactively identify any issues or challenges. Develop, recommend and execute strategies to effectively resolve issues

Work with others to close-out trials, other studies and investigations and complete internal reporting of status and results

  • Communication/Other:

Lead exploratory data analyses to uncover additional medical opportunities for relevant molecules/products

Support others in the interpretation and publication of analyses of real-world data

Work with thought leaders in the publication of exploratory data analyses and analyses of real-world data

Work with MSLs and medical communication specialist to develop responsive medical communication documents and statements

Act as a key contributor to or lead for peer review sessions and, when appropriate, a frequent reviewer in internal review committees

Maintain the highest standards and levels of scientific, clinical and technical expertise in assigned therapeutic area(s)

Required Experience/Knowledge

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.

  • Advanced Clinical/Science Degree (e.g., PhD, MD, PharmD)

Knowledge

  • In-depth knowledge of PV, ICH-GCP and other relevant standards and guidelines
  • Strong knowledge of the overall drug development process (Phase IV drug development experience; Phase I - III drug development is a plus)
  • Proven expertise with a wide range of data/information: including scientific/clinical, safety, legal/regulatory, medical writing, and analytics.
  • Understanding of product and safety profiles
  • Versed in medical aspects of FDA regulations
  • Relevant therapeutic area knowledge

Experience

  • 2-4 or more years' pharmaceutical/biotechnology industry experience or is a recognized expert in the field (with a minimum of 2 years research experience relevant to the pharmaceutical/biotechnology industry)
  • Relevant therapeutic area experience in respiratory/pulmonology/allergy/inflammation (as typically measured by 2 or more years' experience)
  •  Experience in the principles and techniques of data analysis, interpretation and clinical relevance
  • Conference and peer-reviewed manuscript publication experience

Skills/Abilities

  • Proven track record of meeting or exceeding objectives and goals
  • Clinical leadership: subject matter expert in his/her field or potential to become an expert; able to evaluate, interpret and present highly complex data for a series of studies (prospective and retrospective)
  • Strong business acumen: knows the industry, key competitors and other marketplace factors/dynamics
  • Strong project and process management skills: proven abilities to effectively and efficiently manage multiple priorities, goals, objectives and tasks through to successful conclusion
  • Demonstrable abilities to work independently and, when called upon, to oversee the work of others, in strategizing, designing and executing medical plans, clinical research programs, communication programs, and publications. 
  • Strong communication & presentation skills
  • Good negotiation skills
  • Strong interpersonal & partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams
  • Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources
  • Strong customer orientation/focus

Business travel, by air or car, is required for regular internal and external business meetings

5/18/18 Postdoctoral Research Fellow, Simon Williams lab, Genentech Research Individual contributor South San Francisco, California

We are seeking a talented and motivated individual for a Postdoctoral Research Fellowship in the PET imaging laboratory within the Department of Biomedical Imaging, part of our Research and Development organization. The department is well-equipped for PET radiochemistry, quantitative preclinical imaging, and bench work aimed at validating the imaging reagents and methods. The successful candidate is expected to establish and apply PET imaging reagents and methods to help us measure the presence of key cell populations and markers of their activity in preclinical models spanning neurodegeneration, cancer, and their response to novel therapeutics. This will involve the use of PET and optical reporter gene technologies, as well as targeted ligands based on small molecules, peptides, or antibodies as appropriate. For more information on Simon Williams lab, please visit: https://www.gene.com/scientists/our-scientists/simon-williams Information about the postdoctoral program at Genentech can be found at http://www.gene.com/careers/academic-programs/postdocs.

5/18/18 Clinical Specialist, Respiratory - Ann Arbor, MI Individual contributor South San Francisco, California

Product: Esbriet/Xolair
Territory: Ann Arbor, MI

This role is eligible for a streamlined selection process (for displaced Genentech employees) for the first 7 calendar days of the job posting.  Eligible employees who are currently in their pre-notification or formal notification periods will receive priority during this period.


The Clinical Specialist, Respiratory Franchise Sales, 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 brands and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brands in relation to the applicable therapeutic area/disease state. 

In pulmonology, we are focused on two novel therapies.  

  • Esbriet is for the treatment of Idiopathic Pulmonary Fibrosis (IPF), which is a progressive and fatal lung disease and represents a critically unmet medical need. Based on various epidemiology studies and our own research, we estimate that there are between 50,000 and 70,000 patients living with IPF in the United States. Up to 15,000 to 20,000 new patients are diagnosed with IPF every year (www.knowipfnow.com). 
  • Xolair is for the treatment of moderate to severe persistent allergic asthma in patients 6 years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.

You have significant field sales experience in the pharmaceutical/biotechnology industry and have the entrepreneurial spirit and drive to help build our U.S. business and team.  You have sold specialty drugs before, have experience with buy and bill products, and may have specific Pulmonology and/or orphan drug experience. You regularly demonstrate your entrepreneurialism, nimbleness, flexibility and team spirit.

You enjoy working in a team environment and collaborating with other business partners in the field who also support your customers. As an experienced field professional, you have consistently met or exceeded sales and other critical business goals and metrics in a highly complex and competitive market.

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
  • 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:

  • Technical & Business Expertise
  • Inspiring & Influencing
  • Achieving Results
  • Decision-Making
  • Teamwork & Collaboration

NOTE:

  • This is a remote position.
  • This position requires significant use of either a company provided or personal vehicle to perform 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

Qualifications and Experience:
Unless stated as "preferred" or "a plus," all other criteria is required

  • Genentech sales experience preferred
  • Bachelors Degree
  • 2 or more years' field sales experience in the pharmaceutical/biotechnology industry.
  • New product launch experience is strongly preferred
  • 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
  • Previous sales experience in the pharmaceutical, biotech, or related industry is preferred
  • Pulmonary experience preferred
  • Proven track record of meeting or exceeding objectives & goals
  • Previous experience in achieving specific sales plans or other financial targets is preferred

*LI-COMM-MG1

5/17/18 Head, Business Management Office (BMO), PD Personalized Healthcare (PHC) Executive (Director/VP) South San Francisco, California

Considering local candidates only.

Position Summary:

Personalized Healthcare (PHC) creates opportunities to improve outcomes for patients today and in the future.  The PDP function contributes to PHC by deepening capabilities in and delivering value by

  • Accessing meaningful data at scale (high-dimensionality datasets with longitudinal clinical trial data, real-world data, whole genome sequencing, transcriptomics, immune system profiling, anatomic and pathology imaging data, and digital health data)
  • Applying advanced analytics to accelerate insight generation
  • Feeding forward insights re: disease activity/disease characterization to inform research and development decisions which improves our internal productivity and provides evidence to inform external decision-makers including patients, healthcare providers, governments, regulators and public and private payers.

As the Head of the PHC Business Management Office (BMO), you will lead a team of direct reports to enable streamlined operations for the PDP function.  The Business Management Office will partner with PDP Leadership to facilitate business planning, anticipate and support functional decision-making and action taking, forecast resource needs and contribute to solutions, and partner on the definition of functional priorities and track business value and progress attributable to PD PHC. You will form strong relationships with business partners and key stakeholders to sense emergent business needs and provide solid, scalable business solutions for PDP.  

Key Accountabilities/Responsibilities:

People Management/Leadership

  • LEADING: Attract a diverse, talented and productive pool of people; Develop, coach and inspire your direct reports to achieve results and perform at their best; Foster a strong team spirit and learning culture; Design an organization that effectively delivers PDP operational support
  • TEAMWORK & COLLABORATION: Share and leverage operations better practices (e.g., project management, learning & development, communications) and related resources with other PD groups for maximum efficiency; Develop and cultivate strong relationships with group function business partners and stakeholders of the project team system
  • STRATEGY: Clarify your vision of long-term objectives and strategies for the group always targeting value delivery; Communicate the group’s priorities balancing trade-offs between short-term and long-term aspirations

Expertise in Business Operations and Project Management

  • DECISION-MAKING: Ensuring team input and guidance into business operation solution definition and execution; Determining team resource assignments based on project fit, interests and availability
  • PORTFOLIO MANAGEMENT: Introduce and sustain relevant tracking and reporting that enables management action and meaningful interventions to keep functional deliverables on track with expressed commitments; Defining and managing the near-term, forecast and 2-year outlook budget to support the function
  • PROJECT MANAGEMENT: Driving PM excellence across your team with consistent impact across the global PHC project portfolio and PDP organization through best practice methodologies, processes, systems and other tools; Driving in-depth understanding of drug development and how PDP/PHC capabilities and assets integrate to deliver value to R&D and Commercialization decisions.
  • MANAGING CHANGE: Champion and accelerate PDP functional adaptation to change; Embed scalable new practices into the way PDP operates

Skills/Abilities:

  • Leadership:  Demonstrated outstanding leadership of multiple assignments/projects and teams;  Has a track record of achieving outcomes that advance the business; Proven track record for meeting/exceeding quantitative targets and qualitative goals; Role models Roche Leadership Commitments and Product Development Behaviors
  • Business excellence: Possesses in-depth knowledge and broad experience in the pharmaceutical or related industry; Outstanding organizational and time management skills: proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion; Proven ability to plan and resource multiple projects on short-, medium- and longer-term bases; Develops efficient processes based on business knowledge and coordinates with others to get things done
  • Collaboration:  Ability to execute change initiatives in a dynamic global environment effectively collaborating within and across multiple organizations and with stakeholders of various background and skill sets; Skilled in establishing and facilitating a collaborative and respectful team/group environment; Contributes actively to group learning from both success and failures
  • Communication:  Able to simplify a complex set of components into a simple, effective message; Exhibits professional maturity, confidence and competence in communications; Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important business decision; Fluent written and verbal English
  • Initiative:  Able to define priorities and focus on areas that add value; Self-motivated and disciplined to deliver results; Asks for feedback to continuously improve own work and that of the group; Finds ways to scale their team’s assignments to make space for growth opportunities and evolving demands
  • Influencing:  Demonstrated skills in persuading senior leadership on strategy, initiatives implementation and decision-making; Possesses a strong self-awareness to apply appropriate influence skills in varied situations and with various levels in the organization to achieve business objectives; Has a proven track record of building strong and sustainable relationships with internal and external partners/stakeholders
  • Problem solver:  Knows how to apply design thinking and problem solving frameworks; Comfort with ambiguity and demonstrable abilities to learn and adapt quickly; Demonstrates ability to implement and embed solutions.
  • Ability to travel globally

Qualifications/Experience:

  • Bachelors or higher-level Degree (business, life sciences or related discipline is preferred)
  • Project Management certification is a plus
  • 15 or more years’ experience in the pharmaceutical or related industry (additional diagnostics experience is a plus)
  • 3 or more years’ people management experience
  • Up to 15% foreign and domestic travel
  • Extensive project management experience, including:
    • leading large-scale, cross-functional teams in a multicultural, matrix environment
    • strategic planning, risk management, change management, facilitation of workshops, etc.,
    • project management practices, tools  and methodologies
    • budget management

5/17/18 Head, Project Management Office (PMO), PD Personalized Healthcare (PHC) Executive (Director/VP) South San Francisco, California

Considering local candidates only.

Key Accountabilities/Responsibilities:

People Management/Leadership

  • LEADING: Attract a diverse, talented and productive pool of people; Develop, coach and inspire your direct reports to achieve results and perform at their best; Foster a strong team spirit and learning culture; Design an organization that effectively delivers PHC 2.0 commitments made to Pharma Leadership  and PHC stakeholders
  • TEAMWORK & COLLABORATION: Share and leverage Project Management and related resources with other Roche PM groups for maximum efficiency; Develop and cultivate strong relationships with internal and external PHC partners and stakeholders
  • STRATEGY: Clarify your vision of long-term objectives and strategies for the group always targeting value delivery; Communicate the group’s priorities balancing trade-offs between short-term and long-term aspirations

Expertise in PHC Portfolio and Project Management

  • DECISION-MAKING: Ensuring team input and guidance into PHC strategy development and execution; Determining team resource assignments based on project fit, interests and availability
  • PORTFOLIO MANAGEMENT: Introduce and sustain relevant tracking and reporting that enables timely communications and meaningful interventions to keep cross-functional teams on pace with project milestones; Defining and managing the near-term, forecast and 2-year outlook budget to support Roche PHC
  • PROJECT MANAGEMENT: Driving PM excellence across your team with consistent impact across the global PHC project portfolio and PDP organization through best practice methodologies, processes, systems and other tools; Driving in-depth understanding of PHC strategies, capabilities and assets coupled with equally deep knowledge of development and commercialization processes 
  • MANAGING CHANGE: Champion and accelerate PHC capability-building and leveraging of assets internally and externally; Embed new practices into the way we develop transformational medicines for patients

Skills/Abilities:

  • Leadership:  Demonstrated outstanding leadership of multiple projects and teams;  Has a track record of achieving outcomes that advance the business; Proven track record for meeting/exceeding quantitative targets and qualitative goals; Role models Roche Leadership Commitments and Product Development Behaviors
  • Business excellence: Possesses in-depth knowledge and broad experience in the pharmaceutical or related industry; Outstanding organizational and time management skills: proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion; Proven ability to plan and resource multiple projects on short-, medium- and longer-term bases; Develops efficient processes based on business knowledge and coordinates with others to get things done
  • Collaboration:  Ability to execute change initiatives in a dynamic global environment effectively collaborating within and across multiple organizations and with stakeholders of various background and skill sets; Skilled in establishing and facilitating a collaborative and respectful team/group environment; Contributes actively to group learning from both success and failures
  • Communication:  Able to simplify a complex set of components into a simple, effective message; Exhibits professional maturity, confidence and competence in communications; Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important business decision; Fluent written and verbal English
  • Initiative:  Able to define priorities and focus on areas that add value; Self-motivated and disciplined to deliver results; Asks for feedback to continuously improve own work and that of the group; Finds ways to scale their team’s assignments to make space for growth opportunities and evolving demands
  • Influencing:  Demonstrated skills in persuading senior leadership on strategy, initiatives implementation and decision-making; Possesses a strong self-awareness to apply appropriate influence skills in varied situations and with various levels in the organization to achieve business objectives; Has a proven track record of building strong and sustainable relationships with internal and external partners/stakeholders
  • Problem solver:  Knows how to apply design thinking and problem solving frameworks; Comfort with ambiguity and demonstrable abilities to learn and adapt quickly to the rapidly-evolving personalized healthcare landscape and its associated impact on the healthcare ecosystem; Demonstrate ability to implement and embed solutions.
  • Ability to travel globally

Qualifications/Experience:

  • Bachelors or higher-level Degree (business, life sciences or related discipline is preferred)
  • Project Management certification is a plus
  • 15 or more years’ experience in the pharmaceutical or related industry (additional diagnostics experience is a plus)
  • 3 or more years’ people management experience
  • Up to 15% foreign and domestic travel
  • Extensive project management experience, including:
    • leading large-scale, cross-functional teams in a multicultural, matrix environment
    • strategic planning, risk management, change management, facilitation of workshops, etc.,
    • project management practices, tools  and methodologies
    • budget management
5/17/18 Manufacturing Technician, Aseptic Operations Line #3 (HTO) Hillsboro, Oregon

Please note there are five positions available on Line #3 (Lyophilization Line):

  • Day Shift, Sunday through Tuesday (every other Wed), 6:00am to 6:30pm.
  • Two Night Shift, Sunday through Tuesday (every other Sat), 6:00pm to 6:30am
  • Day Shift, Thursday through Saturday (every other Wed), 6:00am to 6:30pm
  • Night Shift, Wednesday through Friday (every other Sat), 6:00pm to 6:30am

Responsibilities:

  • Adhere to all plant safety policies and procedures and proactively identify unsafe conditions Perform safety and housekeeping audits as required
  • Assist in set up, change over, and test run equipment for various-sized vials and packages as required
  • Supporting the Operations Specialist, Maintenance, and/or outside services in the repair, maintenance, and calibration of Genentech systems as required
  • Perform training of other Technicians
  • Assist in the development of plant SOP's and training materials
  • Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems)
  • Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant Perform material handling in the plant as required
  • Perform preparation of sterile components
  • Assist in the cleaning, set-up, sterilization, and dis-assembly on a variety of processing equipment Perform bulk thaw, dilution, and formulation operations
  • Performing manual inspection of empty vials and filled product with a focus on quality and efficiency Conduct environmental monitoring activities in the manufacturing areas as required
  • Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product
  • At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency
  • Work effectively and efficiently in a team-oriented environment to ensure maximum and high quality output Perform cleaning and housekeeping duties as required

Qualifications / Requirements:

  • Proficiency in the English language - reading, writing, and communication
  • Must be able to work all shifts (1st, 2nd, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended periods of time
  • In addition, all candidates must pass a vision acuity and color discrimination test
  • Must complete periodic physical examinations to identify medical conditions which pose a risk to Grade C or higher operation
  • Must have 1 to 2 years (within the last 7 years) experience in the operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers is highly desirable (target industries include pharmaceutical, biotechnology, biomedical, electronic, chemical, food, cosmetics, and/or other medical industries)
  • Must be computer literate, including ability to interface with computer systems and PLC-based logic.
  • Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail. Must possess basic typing skills

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 US.Accommodation@roche.com.

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.