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Senior Director, Pharmacovigilance Operations
Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. At Lyell, our goal is to change that. We are a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for solid tumors based on our innovative technologies. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to defeat solid tumors, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.
POSITION SUMMARY:
The incumbent is responsible for the safety operations function, including the assessment of safety information and implementation of risk management activities for all compounds in development and commercialization. This role can be based in either South San Francisco, CA or Seattle, WA.
KEY ROLE AND RESPONSIBILITIES:
- Define and lead the department including processes (i.e., SOPs), systems, medical evaluation of safety information and risk management activities to assure compliance with global health regulations
- Partner with CMO to create and subsequently lead 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, ensuring 100% timely expedited safety report submissions
- Work closely with study and PV physicians for case review
- Actively contribute functional expertise to 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 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
- Assist with the implementation of appropriate risk management strategies in close collaboration with the business partner, as applicable
- Propose PV department strategic direction and roadmap; manage budget and related activities
- Recruit talent aligned with Lyell’s Culture and Behaviors; build plans for the department including roles, expectations, and outcomes suited to the evolving company model
- 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
PREFERRED EDUCATION:
- BSc with a minimum of 20 years’ experience, or
- MSc with a minimum of 17 years’ experience
PREFERRED EXPERIENCE:
- A minimum of 10 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
Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our
competitive market position and support to our employees and their dependents.
The salary range for this position is $228,000 to $285,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.
Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, 9 day’s sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. More information on our extensive benefits offering can be found here.
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.
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.
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