Director, Global Medical Evidence Generation Lead, Oncology

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Position Summary

The Director of Medical Evidence Generation in Medical Affairs will lead the strategic development and execution of a robust evidence generation plan for an important asset within the Oncology portfolio, focused primarily in gastrointestinal (GI) and genitourinary (GU) cancers, including Clinical Research Collaborations (CRCs), Medical Affairs Sponsored Trials (MAST), and Investigator-Sponsored Research Studies (ISRs), designed to:

• Uncover new clinical development opportunities that will maximize the benefit our medicines can bring to patients

• Address important unmet needs that are gaps in the current clinical development plan

This will be a scientific and strategic leader collaborating across internal functions (Medical Strategy, RWE/Epidemiology, Clinical Operations, Regulatory, HEOR, Access & Value) and with external investigators.

Responsibilities will include, but are not limited to, the following:

• Define and drive the integrated evidence generation strategy aligned with Medical Affairs and overall product strategy, spanning clinical trials (Phase II/IV), real-world evidence (RWE), non-interventional studies, registries, observational research, and health outcomes studies.

• Critically assess the design of research concepts to ensure they are strategically aligned to BMS priorities and can achieve the stated objectives.

• Lead or significantly contribute to protocol development, including Study design, Study objectives and endpoints, eligibility criteria, statistical considerations (in collaboration with Biostatistics), operational feasibility.  Engage in peer-to-peer scientific dialogue with external research partners on collaboration studies to optimize key study design elements

• Be accountable for delivering studies from concept ideation to governance approval and throughout the study lifecycle.

• Serve as a thought leader on evidence generation methodologies to ensure evidence plans are fit-for-purpose and impactful.

• Lead preparation and delivery of evidence generation proposals and updates including results to internal governance bodies and cross-functional stakeholders.

• Apply strong understanding of GCP, ICH guidelines, and clinical trial governance to ensure compliant and high-quality study execution.

• Partner with Clinical Operations and CROs to ensure studies are delivered on time, on budget, and with high data quality.

• Participate in advisory boards, steering committees, and scientific forums as necessary

• Collaborate with cross-functional partners to ensure cohesive planning and execution of evidence generation activities across geographies and therapeutic areas.

• Oversee operational delivery of studies, ensuring scientific rigor, quality, compliance (GCP/SOP), timelines, and budgets.

• Contribute to scientific dissemination through publications, abstracts, congress presentations, and advisory boards

• This position is based at Lawrenceville (PPK), or Madison (GIR) New Jersey.

Qualifications & Experience

• Advanced scientific degree (MD, PhD, PharmD, MS or the equivalent) required with extensive, relevant scientific, and/or strong clinical development experience.

• At least 5 years of experience in pharmaceutical clinical development, Medical Affairs, and/or relevant Commercial experience; previous customer-facing role experience highly desirable.

• Deep understanding of clinical research and evidence generation m