Senior Clinical Trial Physician, Cell Therapy

Role Overview

• Serves as a primary source of medical accountability and oversight for multiple clinical trials
• Matrix management responsibilities across the internal and external network
• Manages Phase 1 – Phase 3 studies, with demonstrated decision making capabilities
• Provides medical and scientific expertise to cross-functional BMS colleagues
• Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT)
• Leads medical data review of trial data, including eligibility review
• Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Leads collaboration with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
• In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
• Provides oversight and medical accountability for a group of studies
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists (CS)
• Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
• Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature
• Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
• Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
• Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Senior Clinical Trial Physician
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with CSs

Requirements

• MD required (or x-US equivalent)
• 5 or more years of Industry experience and/or clinical trials experience is required
• Ability to communicate information clearly and lead presentations in scientific and clinical settings
• Subspecialty training in applicable therapeutic area desired
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Expertise in drug development process
• Expertise in the components needed to execute an effective clinical plan and protocols
• Strong leadership skills with proven ability to lead and work effectively in a team environment

Tech Stack

• Google Cloud Platform

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. 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.