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, Courage and Collaboration and it reflects who we are and the environment we are creating.
You will be responsible for operational and strategic assessment of safety information and implementation of risk management activities for all compounds in development and commercialization. This role can sit in our Seattle or South San Francisco location.
KEY ROLE AND RESPONSIBILITIES:
- Define and lead the strategic development of the department including processes (i.e., SOPs) and systems, medical evaluation of safety information and risk management activities to assure compliance with global health regulations
- Partner with CMO to create and co-chair a multidisciplinary safety committee (i.e. Pharmacovigilance Committee), which reviews select individual serious adverse event cases and aggregate adverse event data for trends, as well as signal detection summaries from all studies
- Oversee the timely assessment and reporting of individual case safety reports (ICSRs) by PV vendor with eventual transition to an internal PV team model, ensuring 100% timely expedited safety report submissions
- Manage and /or participate in strategy discussions for safety data collection for all company products including partnered programs, investigator sponsored trial (IST)/and compassionate-use program (s) to assure a robust safety surveillance program
- Work closely with Regulatory Affairs, Clinical Development and affected business partners, as applicable, to define a strategy on responses to questions from FDA and global health authorities
- Support the preparation of safety-related sections and associated documentation for clinical and regulatory documents (i.e., clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety)
- Provide alliance management support to include review and negotiation of Pharmacovigilance Agreement (s) and /or safety data exchange agreements, as applicable, to ensure robust safety data exchange practices
- Oversee and assist with the implementation of appropriate risk management strategies in close collaboration with the business partner, as applicable
- Define/lead PV department roadmap and budget activities
- Lead PV personnel recruitment effort and department build plan as the company model evolves
- Lead development of departmental SOPs to include safety monitoring procedures to assure company oversight of safety decision-making/governance in the context of outsourced PV vendor model
- Oversee the implementation and maintenance of the safety database (with additional support from the PV consultant team, hosting IT vendor, Biometrics)
- Participate in early commercial launch /readiness activities to assure a successful PV department Pre-Approval Inspection, once applicable
- MD or advanced health related sciences degree (PhD/PharmD); or
- PhD or masters level degree in Epidemiology
- At least 15 years pharmaceutical industry experience or equivalent in Drug Safety/Pharmacovigilance with at least 5 years of direct experience in risk management in a global setting preferred
- Direct experience in a small biotech environment in addition to large pharmaceutical experience is a significant plus
- Immuno-oncology therapeutic area experience or equivalent required; CAR-T experience preferred
- Demonstrated experience managing more junior PV personnel and PV vendor(s)
KNOWLEDGE, SKILLS AND ABILITIES:
- The successful candidate must be well organized, have strong leadership and team building skills, as well as an ability to work effectively in remote-based, multi-functional teams
- Key leadership responsibilities in previous role(s)
- Global responsibilities in previous role(s)
- Excellent working knowledge of GCP, ICH, US IND & EU/GVP regulations and requirements for pharmacovigilance is essential
- Proven ability to effectively lead cross-functional teams with respect to risk management activities and to influence where direct reporting line relationships do not exist
- Excellent 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.