Lyell Immunopharma
A clinical-stage T-cell reprogramming company advancing a pipeline of cell therapies for patients with solid tumors
201 - 500
Senior Director, Pharmacovigilance Operations
September 12
🏢 In-office - San Francisco
Lyell Immunopharma
A clinical-stage T-cell reprogramming company advancing a pipeline of cell therapies for patients with solid tumors
201 - 500
Description
• Define and lead the department including processes and systems • Partner with CMO to create and lead a multidisciplinary safety committee • Oversee the timely assessment and reporting of individual case safety reports • Work closely with study and PV physicians for case review • Actively contribute functional expertise to strategy discussions for safety data collection • Work with Regulatory Affairs and Clinical Development on FDA and global health authorities' responses • Support preparation of safety-related sections for clinical and regulatory documents • Provide alliance management support for safety data exchange agreements • Assist in implementing appropriate risk management strategies • Propose PV department strategic direction and roadmap • Manage budget and related activities • Recruit talent aligned with Lyell’s Culture and Behaviors • Lead development of departmental SOPs for safety monitoring • Oversee implementation and maintenance of the safety database • Participate in early commercial launch/readiness activities
Requirements
• BSc with a minimum of 20 years’ experience, or • MSc with a minimum of 17 years’ 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)
Benefits
• Subsidized medical, dental and vision plans from your first day of employment • FSA • Company provided Life and AD&D Insurance • STD and LTD Insurance • ESPP • 401(k) Plan with Company match • Mass transit commuter benefits • Cell phone reimbursement • 18 days’ vacation • 9 days’ sick leave • 8 observed holidays • Floating holiday • Summer and winter office shutdown
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