The Senior Manager, Global Clinical Science function provides scientific expertise necessary to design and deliver clinical studies and programs.
Position Summary / Objective- Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
- May serve as Clinical Trial Lead for one or more trials
- May lead or support trial level activities for one or more trials with the necessary supervision
- May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
Position 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.)
Degree Requirements - 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)
Experience 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)
Key Competency Requirements - 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)
Travel Required Domestic and International travel may be required.
Compensation Overview:Cambridge Crossing: $173,390 - $210,110 Madison - Giralda - NJ - US: $150,770 - $182,701Princeton - NJ - US: $150,770 - $182,701
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 employee's 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 https://careers.bms.com/life-at-bms/.
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.
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.
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.
On-site ProtocolBMS 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.
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