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Director, Global Medical Evidence Generation Lead, Oncology

Bristol Myers Squibb

Madison, NJ; Princeton, NJHybridPosted 32 days ago$207,490 - $251,433
Full TimeDirector & AboveMedical AffairsPharmaceutical
Original posting ↗

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 and address important unmet needs that are gaps in the current clinical development plan.

Job description

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 and 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

  • 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), and 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.

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 methodologies.
  • Deep oncology therapeutic area expertise, with a focus in GI and GU cancers.
  • Demonstrated ability to strategically analyze data generation opportunities with minimal supervision.
  • Expertise in critically reviewing key study design elements to ensure study objectives can be met.
  • Strategic thinker with strong execution discipline.
  • Demonstrated ability to develop and sustain high-performing, peer relationships with external thought leaders and internal matrix stakeholders.
  • Understanding of global healthcare systems and academic settings with a demonstrated ability to lead in ambiguous and changing healthcare/business environments.
  • Exceptional communication and interpersonal skills to influence decision-making at all levels of the organization and within a matrix environment.
  • Proven experience leading cross-functional study teams and governance interactions.
  • Expected 20% travel globally.

Requirements

  • Advanced scientific degree (MD, PhD, PharmD, MS or equivalent) required
  • At least 5 years of experience in pharmaceutical clinical development, Medical Affairs, and/or relevant Commercial experience
  • Deep understanding of clinical research and evidence generation methodologies
  • Deep oncology therapeutic area expertise, with a focus in GI and GU cancers
  • Demonstrated ability to strategically analyze data generation opportunities with minimal supervision
  • Expertise in critically reviewing key study design elements to ensure study objectives can be met
  • Strategic thinker with strong execution discipline
  • Demonstrated ability to develop and sustain high-performing, peer relationships with external thought leaders and internal matrix stakeholders
  • Understanding of global healthcare systems and academic settings
  • Exceptional communication and interpersonal skills
  • Proven experience leading cross-functional study teams and governance interactions
  • Expected 20% travel globally

Benefits

  • Wellbeing Support
  • Retirement Benefits
  • Financial Protection Benefits
  • Medical, Dental & Vision
  • Life & Disability Insurance
  • Flexible Time Off (FTO)
  • 11 Paid Company Holidays
  • Paid Sick Leave
  • Volunteer Days
  • Summer Hours Flexibility
  • Parental Leave
  • Global Shutdown

Company overview

Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.

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