Executive Director, Medical Safety Assessment - Princeton

About the role

The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. This role involves providing strategic oversight and delivery of medical safety assessment for assets in therapeutic areas.

Responsibilities

• Oversee safety activities and benefit-risk strategies for assigned compound(s)/program(s) and chair the product/TA Safety Management Team (SMT).
• Oversee, Review, and Approve aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
• Oversee team in evaluation & management of signals emerging from any data source. Guide strategy for signal evaluation (eg, case-series, literature review, HA/ claims database).
• Ensure documentation by Safety Topic Review/Signal Report or other means of communication. Approve safety labeling activities for assigned products.
• Provide Safety Subject Matter Expertise for input to regulatory product labeling.
• Drive change in the organization and adoption of new processes.
• Assist the MSA TA Head in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS.
• Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
• Support the R&D publication strategy/plan & ensure safety input to publications/presentations.
• Oversee the global safety strategy for assigned compounds in development. Support global submission document production. Review final summary documents.
• Review safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plans (SAP), ICF, clinical study reports (CSR), responses to health authority (HA) or institutional review board (IRB)/ ethics committee (EC) queries.
• Oversee development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety-focused publication development.
• Ensure medical safety review of DSUR, annual reports, and other periodic safety submissions. Represent WWPS at HA meetings.
• Actively drive benefit-risk strategies for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc.
• Oversee the lifecycle safety strategy for assigned marketed compounds and support global postmarketing safety activities and submissions.
• Provide medical safety, benefit-risk input and approve DSUR/PBRER, product renewal submissions, postmarketing study documents, and reports, responses to HA queries.
• Provide medical safety oversight of and execution of risk management strategies and risk management plan (RMP) elements for assigned products.
• Oversee safety signal evaluation & management. Review and Approve reports on safety signals (ie, Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses.
• Provide postmarketing safety study guidance to other groups including epidemiology and medical affairs, including but not limited to investigator sponsored research/ trials (IST), epidemiology studies, and non-interventional research.
• Ensure safety labeling adequately reflects emerging postmarketing safety profile.
• Hire, Orient, Manage, Mentor, and Develop staff.
• Cross-Functional Activities: Identify data gaps and Prioritize data acquisition. Provide input to strategic plans for safety differentiation of BMS products. Oversee and/or provide training to BMS employees on product safety profiles/issues. Provide input to due diligence and potential in-licensing opportunities as requested. Act as WWPS TA liaison for assigned products with BMS functions (Legal, BD, Operations, Marketing, etc.). Support manufacturing quality. Review integrated health hazard assessments. Review communications of safety data & interpretation to BMS and external parties, globally.
• Leadership Behaviors: Communicate the company's vision, values, and strategies in a way that builds the understanding and commitment of others. Facilitate skill development by coaching others and sharing expertise. Effectively motivate and retain top talent, offer praise, and recognize contributions. Provide team members with regular and constructive performance feedback, encourage sharing better practices and ideas. Resolve conflict within the team so that performance and engagement are not impacted.

Qualifications

• MD/equivalent required.
• Postgraduate qualification or experience in internal medicine, immunology, oncology, or related specialty desirable.
• 7+ years in pharmacovigilance (PV) or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred.
• Management experience is strongly preferred.
• Expert knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
• In-depth understanding of regulatory requirements for safety assessment and action.
• Expert scientific analytical reasoning skills.
• Skilled ability to direct (and leverage) range of available tools to investigate safety concerns, including the science of observational research.

Skills

• Extensive understanding of the drug development process.
• Skilled ability to direct (and leverage) range of available tools to investigate safety concerns, including the science of observational research.
• In-depth understanding of regulatory requirements for safety assessment and action.
• Expert scientific analytical reasoning skills.
• Ability to manage (and work on) multiple complex projects in parallel.
• Excellent attention to detail.
• Behavioral competencies necessary to work and lead within a complex matrix environment.
• Excellent verbal and written communication skills.

Benefits

Not specified.

Pay

$334,860 - $405,769

Schedule

Not specified.