Clinical Trial Physician, Oncology, Medical Evidence Generation

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This Director, Clinical Trial Physician (CTP), Oncology, Medical Evidence Generation (MEG) role in Medical Affairs manages set of studies within the evidence generation Oncology/Hematology portfolio (including Medical Affairs Sponsored studies [MAST], Clinical Research Collaborations (CRCs), and Investigator Sponsored Research (ISRs) – 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 studies in alignment with the Integrated Evidence Plans (IEP) for specified assets.  He/she will work closely with Worldwide Medical (WWM) Therapy Asset Lead, the MEG Oncology 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 in the Oncology portfolio.  This individual 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.

The Clinical Trial Physician 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, CT 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 oversight of Clinical Research Collaborations and ISRs

• 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.

Qualifications & Experience

• Established strategic leadership experience serving at least 5-10 years in a pharmaceutical industry setting and possessing an in-depth understanding of Clinical Development, Medical Affairs, and Commercial functions related to the drug development process.

• MD required (or x-US equivalent) plus 2-3 years of clinical trial experience, either in industry or academic setting; expertise in