Associate Director/Director, Safety Science
Locations: Hayward, California
We are searching for a creative, resourceful, integrative thinker for an important role that will be responsible for providing pharmacovigilance and signal detection expertise to clinical pharmacovigilance deliverables.
The AD/Director Safety Science will provide scientific/clinical expertise and support for safety and benefit-risk evaluations, management of potential safety issues, and evaluation of all safety data for safety signals, including oversight of aggregate reporting for all products. The AD/Director Safety Science should have demonstrated ability to assimilate clinical data, and through comprehensive analysis and review, be able to deliver succinct assessments and communicate these effectively in verbal and written formats.
- Manage the signal management process (i.e., signal detection, tracking, review meetings) for assigned product(s) and evaluates safety data as part of ongoing pharmacovigilance activities.
- Includes synthesis of data from multiple sources and finalizing signal evaluation reports
- Support as key analytic and safety support lead in close collaboration with the heads of medical, clinical and regulatory
- Support safety related activities for clinical trials, including but not limited to review of protocols, ICFs, statistical analysis plans, safety content of Investigator Brochure, and clinical study reports
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Support DMC activities as applicable
- Represents PV as member of cross-functional clinical study management teams for assigned products
- Leads aggregate report management including strategy, review and finalization of aggregate safety reports for assigned products such as PADERs, PBRERs, and DSURs and demonstrates effective leadership skills with cross-functional partners to ensure aggregate reports are of high quality and submitted according to required timelines
- Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents. Responsible for the safety components and co-responsibility for the benefit/risk components together with the Clinical representative
- Develop pharmacovigilance plans and review of data across clinical partnerships and collaborations
- Contribute to the CDP throughout the exploratory and confirmatory phase together with the Clinical representative in order to optimize the benefit/risk profile
- Accountable for the safety components of study reports, aggregate reports and high-level regulatory documents
- Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures
- Enable/facilitate the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety.
- Must be able to work closely and share responsibilities with Safety Operations and vendor management
- MD (board certified or ex-US equivalent), PharmD, RN
- Minimum of 5 years in Drug Safety, Clinical Safety, Pharmacovigilance or Risk Management
- Oncology safety science experience preferred
- Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required)
- Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
- Ability to handle multiple projects with rapidly changing priorities and deadlines.
- Dependable, detail oriented, self- motivated professional with ability to work individually as well as in a matrixed, team environment and be able to work with individuals from multiple functions including clinical operations, regulatory affairs and biometrics
- Excellent written and spoken English
Arcus Biosciences is an equal opportunity employer.