Clinical Trial Physician, Medical Evidence Generation, Oncology
About The Position
This Director, Medical Evidence Generation (MEG) Clinical Trial Physician (CTP) - Oncology role in Medical Affairs manages the evidence generation for the assigned portfolio (including Medical Affairs Sponsored studies [MAST]) and provides clinical support for other studies in the MEG book of work (BOW). In this role, he/she will serve as the primary source of medical/clinical accountability and oversight for a MAST in alignment with the Integrated Evidence Plans (IEP) for the assets in the assigned portfolio. He/she will work closely with Worldwide Medical (WWM) Lead, the MEG Lead, and other members of the study team for the day-to-day oversight and conduction of the clinical studies included in the BOW for an asset. The MEG CTP will lead and participate in cross-functional matrix leadership teams focused on building these relationships and actively sourcing research concepts that address critical evidence gaps for early and late assets being developed in prioritized indications. This role will report to the Medical Evidence Generation Team Lead and will be expected to: Provide medical/clinical accountability and oversight for the various medical affairs-led sponsored studies (interventional and non-interventional), in alignment with the Integrated Evidence Plans (IEP) for the assets in company’s portfolio. Collaborate with the TA Medical Lead, MEG Lead, Clinical Scientist (CS), and Global Trial Manager (GTM) for the development of the study protocol and ICF, authoring and providing medical input during protocol development. Partner with Clinical Scientist (CS) and Global Trial Manager (GTM) to support executional delivery of studies (e.g., clinical database development, clinical data oversight, site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.). Hold responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives (if applicable). Accountable for medical data review of trial data, including eligibility assessment and interpretation of trial data results. Provide medical oversight and accountability for the study-related work conducted by external partners (CROs), particularly related to medical monitoring-related activities. Provide continuous medical education in partnership with CTLs and T/A Medical Leads related to protocol-specific training (supporting the study team, investigators, CROs, and others). Provide medical expertise during Study Steering Committees, Investigators’ Meetings, and other study-related meetings with external audiences. Build relationships with principal investigators and other relevant external stakeholders. Responsible for partnering closely with key stakeholders across Medical, including the Clinical Research Collaborations group, working on the cell therapy portfolio to ensure cohesiveness and one MEG voice. Fulfill GCP and compliance obligations for clinical conduct and maintains all required training. Employ strong business acumen and fiscal stewardship focused on driving reciprocal scientific value creation and allocate resources consistent with company priorities.
Requirements
- MD required (or x-US equivalent)
- 2-3 years of clinical trial experience, either in industry or academic setting
- Expertise in drug development process and clinical research
- Established strategic leadership experience, ideally with ~5+ years’ experience in a pharmaceutical industry setting
- In-depth understanding of Clinical Development, Medical Affairs, and Commercial functions related to the drug development process.
- Adeptness at building credibility with external investigators and collaborative partners competently balancing business and scientific acumen complemented by strong leadership behaviors, authenticity, agility, and an enterprise mindset.
- Demonstrated ability to develop and sustain a high-performing team along with a proven ability to successfully lead teams (including matrix colleagues)
- Demonstrated track record of leadership in a complex, matrix environment.
- Exceptional communication and interpersonal skills to influence decision-making at all levels of the organization.
Nice To Haves
- Experience with implementation and conduction of medical affairs-led studies and/or cell therapy clinical development desirable.
Responsibilities
- Provide medical/clinical accountability and oversight for the various medical affairs-led sponsored studies (interventional and non-interventional), in alignment with the Integrated Evidence Plans (IEP) for the assets in company’s portfolio.
- Collaborate with the TA Medical Lead, MEG Lead, Clinical Scientist (CS), and Global Trial Manager (GTM) for the development of the study protocol and ICF, authoring and providing medical input during protocol development.
- Partner with Clinical Scientist (CS) and Global Trial Manager (GTM) to support executional delivery of studies (e.g., clinical database development, clinical data oversight, site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.).
- Hold responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives (if applicable).
- Accountable for medical data review of trial data, including eligibility assessment and interpretation of trial data results.
- Provide medical oversight and accountability for the study-related work conducted by external partners (CROs), particularly related to medical monitoring-related activities.
- Provide continuous medical education in partnership with CTLs and T/A Medical Leads related to protocol-specific training (supporting the study team, investigators, CROs, and others).
- Provide medical expertise during Study Steering Committees, Investigators’ Meetings, and other study-related meetings with external audiences. Build relationships with principal investigators and other relevant external stakeholders.
- Responsible for partnering closely with key stakeholders across Medical, including the Clinical Research Collaborations group, working on the cell therapy portfolio to ensure cohesiveness and one MEG voice.
- Fulfill GCP and compliance obligations for clinical conduct and maintains all required training.
- Employ strong business acumen and fiscal stewardship focused on driving reciprocal scientific value creation and allocate resources consistent with company priorities.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
