Senior Manager, Global Clinical Science, Neuroscience

Bristol Myers Squibb • Madison, MA

10d • Hybrid

About The Position

The Senior Manager, Global Clinical Science function provides scientific expertise necessary to design and deliver clinical studies and programs. This role will be responsible for the design and execution of assigned clinical trial activities and will work closely with clinical team members within the assigned project to execute activities associated with the conduct. The role may serve as a Clinical Trial Lead for one or more trials, may lead or support trial level activities for one or more trials with the necessary supervision, and may co-lead study team meetings in partnership with the GDO protocol manager and collaborate with cross-functional study team members.

Requirements

• Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Ability to understand assigned protocol(s) and their requirements
• Basic knowledge skills to support program-specific data review and trend identification
• Intermediate medical writing skills and medical terminology
• Basic planning/project management skills (develop short range plans that are realistic and effective )
• Detail-oriented with commitment to quality
• Basic knowledge of disease area, compound, current clinical landscape
• Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Intermediate critical thinking and problem-solving skills
• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)

Nice To Haves

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)

Responsibilities

• Collaborate and liaise with external partners (e.g., KOLs)
• Seek out and enact best practices with instruction
• Provide regular and timely updates to manager/management as requested
• Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
• Conduct literature review
• Submit clinical documents to TMF
• Develop site and CRA training materials and present these at SIVs and Investigator meetings
• Review clinical narratives
• Monitor clinical data for specific trends
• Develop Data Review Plan in collaboration with Data Management
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)

Benefits

• 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.
• Work-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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior