Our client’s 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 Respect, Science, Courage and Collaboration and it reflects who we are and the environment we are creating.
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.
JOB 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.
- MD or advanced health related science degree (PhD/PharmD); or equivalent
- PhD or masters level degree in Epidemiology an asset
- 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
JOB REQUIREMENTS
- A minimum of 5 years relevant Pharmacovigilance and Risk Management experience
- Appropriate experience with Health Authority and key stakeholder interactions
- Demonstrated experience in:
- Cellular therapy / immunotherapy
- Aligning strategies with business partners
- Line-management
#J-18808-Ljbffr
