Job Details
Executive Director, Medical Safety Assessment Therapeutic Lead, Gastroenterology & Multiple Sclerosis
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.
Position Summary/Objective:
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.
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.
Degree Requirement:
MD/equivalent required. Postgraduate qualification or experience in internal medicine, immunology, oncology, or related specialty desirable.
Experience Requirements:
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.
Key Competency Requirements:
Extensive understanding of the drug development process.
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.
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.
Travel Required:
Occasional travel within the US (eg, once every 2-3 months) and overseas (eg, once a year)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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