Clinical Trial Physician – Oncology – Medical Evidence Generation

Clinical Trial Physician – Oncology – Medical Evidence Generation

Requirements

• MD required (or x-US equivalent) plus 2-3 years of clinical trial experience, either in industry or academic setting; expertise in drug development process and clinical research; experience with implementation and conduction of medical affairs-led studies and/or oncology clinical development desirable.
• 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.
• 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.

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, 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.

Preferred Qualifications

• Experience with implementation and conduction of medical affairs-led studies and/or oncology clinical development desirable.