Executive Director, Medical Safety Assessment - Princeton

Job Title

Provide strategic oversight & delivery of medical safety assessment for assets in therapeutic area (TA) by effective management of safety physician team.

Position Responsibilities:

General Product Support:

• 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 (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).
• 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.
• Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
• Provide input to R&D publication strategy/ plan & ensure safety input to publications/ presentations.

Clinical Development:

• Oversee the global safety strategy for assigned compounds in development. Support global submission document production. Review final summary documents.
• Oversee medical safety development and execution of benefit-risk management strategies for assigned products.
• 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.

Postmarketing Support:

• 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.

Department Activities:

• 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 preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
• Assist the team and senior management in all forms of issue management and crisis management.
• Liaise with all TA staff and maintain an effective and collaborative patient safety team.
• 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.