Position Summary / Objective- Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials
- Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
- Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)
- Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members
- May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)
Position Responsibilities- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Plan and lead the implementation all study startup/conduct/close-out activities as applicable
- Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
- Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
- Site-facing activities such as training and serving as primary contact for clinical questions
- Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Clinical data trend identification; provide trends and escalate questions to Medical Monitor
- Develop clinical narrative plan; review clinical narratives
- Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
Degree Requirements- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
Experience Requirements- 5+ years of experience in clinical science, clinical research, or equivalent
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Key Competency Requirements- Excellent verbal, written, communication and interpersonal skills
- Must be able to effectively communicate and collaborate across functions and job levels
- Ability to assimilate technical information quickly
- Routinely takes initiative
- Detail-oriented
- Strong sense of teamwork; 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 (including MOA, PK/PD, biomarker & safety profile)
- Proficient critical thinking, problem solving, decision making skills
- Understanding of functional and cross-functional relationships
- Commitment to Quality
- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
Travel RequiredDomestic and International travel may be required.
Compensation Overview:Cambridge Crossing: $211,910 - $256,789 Madison - Giralda - NJ - US: $184,270 - $223,294Princeton - NJ - US: $184,270 - $223,294
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 WorkWhere 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.
