At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

·       Serves as a primary source of medical accountability and oversight for multiple clinical trials

·       Manages Phase I/II studies, with demonstrated decision making capabilities,

·       Provides medical and scientific expertise to cross-functional BMS colleagues,

·       Maintains matrix management responsibilities across internal and external networks

Duties/Responsibilities

Medical Monitoring

·       Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by: Articulating clinical development strategy, Analyzing, interpreting, and acting on clinical trial data to support development, Serving as principal functional author for Regulatory submission, study reports, and publications

·       Provides oversight and medical accountability for multiple trials across early development clinical lifecycle

·       Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)

·       Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives

·       Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team

·       Collaborates with Clinical Scientists and provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)

·       Fulfills GCP and compliance obligations for clinical conduct and maintains all required training

·       Acts as a focal point for defining and establishing relationships with key global Phase I Centers

·        Works on multiple trials across early development clinical lifecycle

Clinical Development Expertise & Strategy

·       Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies

·       Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)

·       Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists.

·       Partners with Clinical Scientists to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)

·       Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder

·       Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature

·       Clinical Development Expertise & Strategy

·       Designs and develops clinical studies and research plans in support of asset strategy

with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies

·       Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)

·       Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists

·       Partners with Clinical Scientists to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)

·       Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder

·       Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature

Health Authority Interactions

·       Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects

·       Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists

External Partnerships, Alliances, and Publications

·       Sits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies

·       Represents department in business development due diligence and partner alliance management with oversight

·       Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers

·       Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)

Reporting Relationship

Reports to: Executive Director, Early Clinical Development, Solid Tumors.

Qualifications

·       Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent)

·       Subspecialty fellowship training in applicable therapeutic area preferred

·       5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable

·       Ability to communicate and present information clearly in scientific and clinical settings

·       Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation

·       Knowledge of drug development process

·       Knowledge of the components needed to execute an effective clinical plan and protocols

·       Strong leadership skills with proven ability to lead and work effectively in a team environment

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [email protected]with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.