Director, Pharmacovigilance and Risk Management

Location
98109, Seattle
Posted
May 05, 2022
Required Education
Bachelors Degree
Position Type
Full time

At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.

 

POSITION SUMMARY:

You will be responsible for the operational and strategic assessment of safety information, signal detection, and implementation of Risk Management (RM) activities for all compounds in development and commercialization in a small biotech environment. This role will help build the RM infrastructure and work cross-functionally to assure achievement of optimum benefit-risk throughout the lifecycle of all applicable products.  This role can sit in either our Seattle or South San Francisco location. 

KEY ROLE AND RESPONSIBILITIES:

  • Lead and help design safety risk management strategy and implementation of modern processes, best practices, venues, and cross-functional collaboration.
  • Utilize medical and safety science expertise to continually assess the relevance and potential impact of product characteristics on the developing benefit risk profile.
  • Actively perform and oversee emerging safety data review and develop strategy to identify and analyze potential safety signals from various sources.
  • Chair/co-chair product Safety Management Teams, safety data review venues, and multidisciplinary safety committee.
  • Champion the use of epidemiologic tools to better aid the understanding of observed and anticipated adverse event rates in key populations.
  • Author and oversee applicable sections of periodic safety reports (DSUR, PADER, PBRER/PSUR) and ad hoc regulatory reports.
  • Lead and participate in the development and preparation of safety-related sections and associated material for clinical documents (ex. protocols, CSRs, IBs, ICFs, SAPs).
  • Lead safety activity for product filings and contribute to associated document preparation (ex. BLA, ISS/SCS) and safety sections of key documents (ex. company core data, safety labeling).
  • Collaborate with Head of PV to define strategy and lead development of safety-related responses to queries from health authorities and IRBs.
  • Drive safety-related preparation and represent PV/risk management at product-specific health authority and data monitoring committee meetings.
  • Represent department as medical safety lead on cross-functional study/program teams and appropriate governance bodies, providing expert guidance regarding safety matters and issues and to assure that PV/RM decisions are effectively communicated.
  • Work closely with cross-functional colleagues and business partners to define key strategic decisions for management and communication of emerging safety issues for compounds in development and commercialization.
  • Communicate effectively to management resource needs and timelines to ensure compliance with regulatory requirements.
  • Actively mentor PV staff and contribute to the development and rapid growth of a state-of-the art PV department.
     

 PREFERRED EDUCATION: 

  • MD or advanced health related science degree (PhD/PharmD); or equivalent
  • PhD or masters level degree in Epidemiology an asset

 PREFERRED EXPERIENCE:

  • A minimum of 5 years relevant Pharmacovigilance and Risk Management experience 
  • Appropriate experience with Health Authority and key stakeholder interactions
  • Demonstrated experience in:
    • Solid tumors
    • Cellular therapy / immunotherapy
    • Epidemiology
    • Aligning strategies with business partners
    • Line-management

KNOWLEDGE, SKILLS AND ABILITIES:

  • Excellent knowledge of ICH, US, and EU regulations and requirements for PV
  • Communicates complex issues in an understandable and effective manner
  • Ability to explain and defend positions regarding significant issues in the face of opposition
  • Excellent analytical and problem-solving skills, with sound autonomy and applied judgment
  • Ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist
  • Effective leader and team member
  • Ability to mentor junior PV personnel and work in highly matrixed environment
  • Exceptional written and spoken English

 

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

 

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”

 

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.