Senior Clinical Scientist, Late Oncology

Bristol-Myers Squibb - Princeton, NJ

Full-time - Mid Level

Princeton, NJ

Chemical Manufacturing

About the position

The Senior Clinical Scientist at Bristol Myers Squibb plays a pivotal role in the Clinical Science function, which is essential for the design and delivery of clinical studies and programs. This position is responsible for the implementation, planning, and execution of assigned clinical trial activities, and may serve as the Clinical Trial Lead for one or more trials. The Senior Clinical Scientist will successfully lead, plan, and execute trial-level activities for multiple trials with minimal to moderate supervision. This role requires providing scientific and clinical leadership to a team of supporting Clinical Scientists, demonstrating matrix leadership skills. In this position, the Senior Clinical Scientist will co-lead study team meetings in partnership with the Global Trial Manager and collaborate with cross-functional study team members. They may also support clinical development planning in collaboration with the Clinical Development Lead or Clinical Trial Physician, providing and analyzing data to support future planning. A thorough understanding of assigned protocols and protocol requirements is crucial, as the Senior Clinical Scientist will educate supporting team members and lead the implementation of all study startup, conduct, and close-out activities as applicable. The role involves evaluating innovative trial designs in collaboration with the Medical Monitor, Clinical Development Lead, and Clinical Team Lead. The Senior Clinical Scientist will also be involved in the protocol and informed consent form (ICF) development process, which includes writing, reviewing, adjudicating, and resolving cross-functional comments to ensure high clinical quality. Site-facing activities such as training and serving as the primary contact for clinical questions are also part of the responsibilities. Additionally, the Senior Clinical Scientist will engage in activities related to data generation and validation, including clinical data review and query resolution, ensuring consistent and quality data review by the supporting Clinical Scientist team. The position requires the development of clinical narrative plans, reviewing clinical narratives, and providing necessary information for the development of trial budgets and CRO scopes of work. The Senior Clinical Scientist will also review the development of site and CRA training materials, present at site initiation visits (SIV) and investigator meetings, and support study committee activities. Drafting, reviewing, and validating clinical study reports (CSRs) and clinical portions of regulatory documents are also key responsibilities. Collaboration and serving as the primary liaison between external partners for scientific advice are essential components of this role.

Responsibilities

• Implement, plan, and execute assigned clinical trial activities.
• Serve as Clinical Trial Lead for one or more trials.
• Lead trial-level activities for multiple trials with minimal to moderate supervision.
• Provide scientific and clinical leadership to a team of supporting Clinical Scientists.
• Co-lead study team meetings in partnership with Global Trial Manager.
• Collaborate with cross-functional study team members.
• Support clinical development planning in collaboration with Clinical Development Lead/Clinical Trial Physician.
• Maintain a thorough understanding of assigned protocols and protocol requirements.
• Plan and lead the implementation of all study startup, conduct, and close-out activities.
• Evaluate innovative trial designs in collaboration with Medical Monitor and Clinical Development Lead.
• Develop protocols and ICF with minimal guidance, ensuring high clinical quality.
• Conduct site-facing activities such as training and serving as primary contact for clinical questions.
• Engage in data generation and validation activities, including CRF design and clinical data review.
• Identify clinical data trends and escalate questions to Medical Monitor.
• Develop clinical narrative plans and review clinical narratives.
• Provide information required for trial budget and CRO scope of work development.
• Review development of site and CRA training materials and present at SIV and Investigator meetings.
• Draft, review, and validate clinical study reports and clinical portions of regulatory documents.
• Collaborate and serve as primary liaison between external partners for scientific advice.

Requirements

• 5+ years of experience in clinical science, clinical research, or equivalent (oncology experience preferred).
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations.
• Proficient knowledge and skills to support program-specific data review, trend identification, and data interpretation.
• Proficiency with Electronic Data Capture (RAVE), J-Review, Spotfire, and/or similar data reporting tools.
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
• Excellent verbal, written, communication, and interpersonal skills.
• Ability to effectively communicate and collaborate across functions and job levels.
• Ability to assimilate technical information quickly.
• Detail-oriented with a strong sense of teamwork and ability to lead team activities.
• Proficient in Medical Terminology and medical writing skills.
• Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study.
• Proficient critical thinking, problem solving, and decision-making skills.
• Understanding of functional and cross-functional relationships.
• Commitment to Quality and adaptability to multiple demands and shifting priorities.
• Proficient planning/project management skills.

Nice-to-haves

• Experience in oncology clinical trials.
• Familiarity with regulatory submissions and compliance processes.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health insurance plans.
• 401(k) retirement savings plan with company matching.
• Flexible work arrangements and remote work options.
• Paid time off and holidays.
• Tuition reimbursement for further education.
• Employee wellness programs and resources.