Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience

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

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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.

- 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. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.

- 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.

- 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.

- Ability to manage (and work on) multiple complex projects in parallel.

- Behavioral competencies necessary to work and lead within a complex matrix environment.

Travel: Occasional travel within the US (eg, once every 2-3 months) and overseas (eg, once a year)

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.

For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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R1602638 : Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience