Director, Global Medical Evidence Generation Lead, Oncology
About The Position
The Director of Medical Evidence Generation in Medical Affairs will lead the strategic development and execution of a robust evidence generation plan including Medical Affairs Sponsored Trials (MAST), Clinical Research Collaborations (CRCs), and Investigator-Sponsored Research studies (ISRs) for an important asset within the Oncology portfolio across various tumor types. These studies will be 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 Generate practice informing data to advance patient care This will be a scientific and strategic leader collaborating across internal functions (Medical Strategy, Clinical Development & Operations, HEOR, RWE/Epidemiology, Access & Value, Regulatory) and external investigators.
Requirements
- 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 experience
- Deep understanding of clinical research and evidence generation methodologies
- Deep oncology therapeutic area expertise
- 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
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 through governance approval and ultimately data readout.
- 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.
- Contribute to scientific dissemination through review of publications (manuscripts, abstracts and congress presentations) and advisory boards
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays each year
- 160 hours of paid vacation annually for new hires
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Director
