Protocol Manager Jobs in Massachusetts (NOW HIRING)

Reports through the Clinical Development function which provides scientific expertise necessary to design and deliver clinical studies and programs.

• 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 supervision.
• Provides scientific and clinical leadership to a team of supporting Clinical Scientists (matrix leadership).
• Co‑leads study team meetings in partnership with GDO protocol manager and collaborates with cross‑functional study team members.
• May support clinical development planning by collaborating with Clinical Development Lead or Clinical Trial Physician for the provision and analysis of data to support future planning.

• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members.
• Plan and lead the implementation of all study startup, conduct, and close‑out activities as applicable.
• Evaluate innovative trial designs in collaboration with Medical Monitor and Clinical Development Lead.
• Lead protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross‑functional comments and ensuring high clinical quality in collaboration with Medical Writing.
• Conduct site‑facing activities such as training and serving as primary contact for clinical questions.
• Oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team.
• Identify clinical data trends; provide trends and elevate questions to Medical Monitor.
• Develop clinical narrative plan and review clinical narratives.
• Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
• Review development of site and CRA training materials and presentations at SIV and Investigator meetings; support on Study committee (e.g., DMC) activities.
• Draft/review and validate 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 in Life Sciences (MD, PhD, PharmD, MS, RN, or other scientific field preferred).

• 5+ years of experience in clinical science, clinical research, or equivalent.
• 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.
• Knowledge of establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.

• Excellent verbal, written, communication, and interpersonal skills.
• Ability to communicate and collaborate across functions and job levels.
• Ability to assimilate technical information quickly.
• Initiative, detail‑orientation, and strong sense of teamwork.
• Proficient in Medical Terminology and medical writing skills.
• Proficient knowledge of disease area(s), KOLs, indications, compounds under study (including MOA, PK/PD, biomarker & safety profile).
• Proficient critical thinking, problem solving, and decision‑making skills.
• Understanding of functional and cross‑functional relationships.
• Commitment to quality.
• Adaptability and flexibility to adjust to multiple demands and shifting priorities.
• Proficient planning/project management skills.
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J‑Review or similar data reporting tools.

Domestic and international travel may be required.

Cambridge Crossing: $211,910 - $256,789… Madison - Giralda - NJ - US: $184,270 - $223,294… Princeton - NJ - US: $184,270 - $223,294

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. Final, individual compensation will be decided based on demonstrated experience.

• 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.
• Paid Time Off: US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays). Phoenix, AZ, Puerto Rico and Rayzebio employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
• Additional time off for eligible 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.

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