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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Director, Global Medical Evidence Generation Lead - Oncology

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • An advanced scientific degree (MD, PhD, PharmD, MS, or equivalent) and extensive relevant scientific and/or strong clinical development experience are 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, focused on gastrointestinal and genitourinary cancers.
  • Ability to strategically analyze data-generation opportunities with minimal supervision and critically review study design elements to ensure study objectives can be met.
  • Ability to develop and sustain peer relationships with external thought leaders and internal matrix stakeholders.
  • Understanding of global healthcare systems and academic settings, and ability to lead in ambiguous and changing healthcare/business environments.
  • Ability to influence decision-making at all organizational levels and within a matrix environment.
  • Proven experience leading cross-functional study teams and governance interactions.

Responsibilities

  • Define and drive an integrated evidence-generation strategy aligned with Medical Affairs and overall product strategy, covering Phase II/IV clinical trials, real-world evidence, non-interventional studies, registries, observational research, and health outcomes studies.
  • Critically assess research-concept designs for strategic alignment with company priorities and ability to achieve stated objectives.
  • Lead or significantly contribute to protocol development, including study design, objectives and endpoints, eligibility criteria, statistical considerations in collaboration with Biostatistics, and operational feasibility; engage external research partners in scientific dialogue to optimize study-design elements.
  • Be accountable for delivering studies from concept ideation through 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 understanding of Good Clinical Practice, International Council for Harmonisation guidelines, and clinical-trial governance to ensure compliant, high-quality study execution.
  • Partner with Clinical Operations and contract research organizations to deliver studies on time, on budget, and with high data quality.
  • Participate in advisory boards, steering committees, and scientific forums as needed.
  • Collaborate with cross-functional partners to coordinate evidence-generation planning and execution across geographies and therapeutic areas.
  • Oversee study operational delivery, ensuring scientific rigor, quality, compliance with Good Clinical Practice and standard operating procedures, timelines, and budgets.
  • Contribute to scientific dissemination through publications, abstracts, congress presentations, and advisory boards.

Desired Qualifications

  • Previous experience in a customer-facing role is highly desirable.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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