Director, Head of Medical Review Immuno-Oncology

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Functional Area Description

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines. This includes all pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Position Summary / Objective

The TA Head – Medical Safety Review provides leadership for Medical Safety Review Physicians (MRSPs) and oversight for vendor activities regarding Medical Review (MR) of all products within the assigned therapeutic area (TA). Provides MR expertise and makes informed MR decisions in cross-functional meetings on critical ICSRs from the TA in order to protect patients, BMS products, and BMS regulatory compliance.

Position Responsibilities

Strategic: Drives continuous improvement and transformation of PV Operations into a highly automated, efficient organization dedicated to achieving industry-leading quality, compliance, and cost effectiveness. Collaborates to build Medical Review capabilities in all global PVOpS sites. Drives change-management in Medical Review regarding process innovation. Creates strategy and provides oversight of single case processing vendor re: medical review for TA products.

Management: Manages and develops the Medical Review Safety Physicians (MRSPs) within the therapeutic area. Provides training and acts as mentor to Medical Review Safety Physicians. Takes the lead in assuring consistent application of work practices and processes. Delegates to and develops MRSPs to ensure talent retention and succession planning.

Medical Review: Subject Matter Expert (SME) for products within the assigned TA, provides medical review oversight of ICSRs. Leads Case Processing & Review Meetings for TA. Oversees execution of RMP re: ICSR-related PV activities. Involved in HA-commitment review and execution pertaining to ICSR assessment and reporting. For products within the assigned TA, ensures high quality medical assessment of ICSRs with particular attention to critical cases (SUSARs, AEs of Interest, potential Drug-Induced Liver Injury [pDILI], pregnancy, any critical events). Provides final decision when needed on seriousness, causality and expectedness assessment and determines regulatory reportability of ICSRs. Provides input the development of the Reference Safety Information section of the Investigator’s Brochure; provides peer review as needed for safety documents (RMP, IB, aggregate reports, labels for marketed products).

Compliance: Ensures MRSPs meet/exceed expectations for compliance, quality, regulatory and safety initiatives. Leads all quality monitoring efforts related to TA product knowledge and medical assessment. Collaborates with PV Operational Excellence and CQL Teams to ensure consistency of work practices and SOPs. Supports audits and health authority inspections representing Medical Review. Applies BMS operating philosophy and operate within company policies and procedures and appropriate regulations. 

Collaboration: Partners with WWPS personnel at similar leadership level (Case Management Leads, PV Scientist Leads, and SMT Chairs, MSA TA Heads) and personnel from other functions and external stakeholders. Serves as the medical review SME of assigned TA on cross-functional teams. Contributes to the evaluation the safety profile of BMS compounds within the therapeutic area of responsibility. Ad hoc member of SMT. Identif