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Director, Global Medical Evidence Generation Lead, Oncology

External
Bristol-Myers Squibb logoBristol-myers Squibb · Princeton, NJ
Part-timeRemote1w ago
Clinical TrialsComplianceGCP
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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. 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 . 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 followin g: 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 & Experienc e 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 communicat


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