Senior Director, PS TA Safety Physician
Cambridge, United Kingdom
You will develop or oversee and ensure that strategic medical input relative to safety is incorporated into product development and lifecycle management as well as perform or oversee other advanced safety science activities for a portfolio of products in the assigned therapeutic area.
You will provide strategic input into cross-functional drug development planning and execution across the product lifecycle, from discovery to postmarketing. You will ensure that signal detection, development of benefit-risk evaluation management plans, risk minimization activities, and aggregate safety reports are performed in a timely and quality manner. You will also provide input on behalf of PS into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries, pharmacovigilance (PV) processes and projects and PV or other audits and inspections. You may be assigned responsibilities as a Global Safety Lead (GSL) or Global Safety Strategy Lead (GSSL) with responsibilities for managing a group of products/or indications and acting as the expert, strategic partner across Gilead regarding these compounds. You will play a lead role within the PS TA by contributing to the group’s short- and long-range strategy, infrastructure and resource plans, and long-range capability development. You will also mentor and develop future PS TA leaders.
- Typically leads and manages a team of direct reports and may manage other people leaders. Hires, develops and retains diverse top talent on the team. Sets clear and elevating goals for the team and individual direct reports. Coaches direct reports on their performance, development and career interests.
- Makes significant contributions to our abilities to hire, develop and retain diverse talent with impact in and outside own team.
- Accountable for the successful oversight and completion of a broad spectrum of safety science activities and deliverables for typically multiple products, compounds or indications in the assigned TA, in compliance with established practices, policies, processes, and any regulatory or other requirements.
- Advises senior management on the safety strategy and pathway to achieve therapeutic area strategic milestones and objectives.
- May provide input into and influence cross-TA PS strategies.
- Performs or otherwise oversees safety reviews of clinical trial protocols, clinical study reports, informed consent forms, and other study related documents.
- Provides and/or oversees medical input on PV activities for products within the assigned TA.
- Authors, contributes to and/or oversees the preparation of aggregate safety reports and risk management plans (RMPs).
- Conducts and/or oversees signal detection and evaluation activities for assigned products as part of the continuous benefit-risk evaluation throughout the product lifecycle.
- Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.
- Contributes to and/or oversees PS TA activities and input related to regulatory filings (e.g., Marketing Authorisation Applications [MAAs], New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies.
- Plays a leadership role on PS and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and PS TA functional area support in PV audits and inspections.
- May serve as medical monitor for post-authorization safety studies.
- Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
- Ensures the team and the assigned work comply with established practices, policies and processes and any regulatory or other requirements.
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
- U.K. Education & Experience
- MBBS degree or equivalent
- Completion of training in a medical or surgical residency program.
- Certificate of Completion of Training is strongly preferred.
- Clinical care experience in HIV is preferred.
- Experience leading cross-functional activities across a broad spectrum of drug safety or related programs, projects and other activities.
- Experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
- Line management (direct reports) experience is strongly preferred.
- Proven track record of effective people leadership, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.
- Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.
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