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 strategywith 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
- Abilityto 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
If you come across a role that intrigues you but doesn27t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Brisbane - CA - US: $308,700 - $374,075
Cambridge Crossing: $308,700 - $374,075
Madison - Giralda - NJ - US: $275,630 - $333,998
Princeton - NJ - US: $275,630 - $333,998
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 employee27s 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
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.
0Work-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.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as 22Transforming patients27 lives through science22, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
