Position SummaryThe 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 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.
#LI-HYBRIDCompensation Overview:Madison - Giralda - NJ - US: $207,490 - $251,433Princeton - NJ - US: $207,490 - $251,433
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
