Our client is a clinical stage biopharmaceutical company developing immunotherapies to treat cancer. They have retained us to assist in their search for a Medical Director/Senior Medical Director.

Major tasks and responsibilities include:

• Develop and execute Phase 1-3 clinical trials of the company’s investigational viral immunotherapies in close collaboration with a cross-functional team.
• Provide leadership, project management, direction, and program oversight to plan and conduct high-quality clinical trial protocols according to the specified clinical protocol, Good Clinical Practices (GCP), and FDA regulations.
• Author/review clinical trial documents, including study synopses, protocols, amendments, safety monitoring plans, risk management plans, clinical sections of IND reports, process documents, presentations, publications, and clinical sections of regulatory documents to support product approvals.
• Conduct and support study trainings for investigators, study sites, and internal teams to share clinical and scientific insights, ensuring engagement and optimized enrollment.
• Conduct regular review, analysis, and interpretation of study results.
• Act as the clinical team's medical reference, overseeing study implementation and study medical monitoring.
• Actively oversee Pharmacovigilance activities in collaboration with clinical teams, including real-time medical monitoring of clinical trials. Responsibilities include assessing patient eligibility, addressing study design inquiries, and responding to urgent safety concerns to ensure patient safety, regulatory compliance, and efficient communication of drug safety information to clinical teams and senior management.
• Participate in identification/analysis of any potential safety concerns and/or adverse events across trials and ensure these are properly tracked and recorded.
• Provide scientific input and strategic guidance to the clinical team on study conduct, protocol adjustments, and safety/efficacy assessments.
• Proactively monitor and report trial performance, progress, and timelines.
• Work closely with cross-functional teams, including clinical operations, data management, statistics, regulatory affairs, biomarker scientists, and information technology (IT), to ensure effective coordination and seamless collaboration.
• Stay current on scientific and clinical advancements in relevant therapeutic areas and communicate key insights to internal teams.
• Build and maintain relationships with external experts, regulators, key opinion leaders, and disease specific investigator networks to enhance trial success.
• Participate in recruitment of new employees to ensure department is staffed with qualified personnel.

We seek candidates with the following qualifications:

• Doctor of Medicine (MD) degree required, PhD preferred.
• Must have a minimum of 5 years of industry experience in clinical development, with a focus on oncology.
• Board certification in oncology (following residency training) and experience in translational research preferred.
• Extensive clinical research experience across all phases.
• Proven expertise in clinical medicine and biomedical research is essential.
• Demonstrated record of scientific scholarship and achievement.
• Working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH guidelines.
• Experience in writing reports for external presentations and medical journal publications is essential.
• Ability to manage and coordinate patient data acquisition from collaborating institutions.
• Strong interpersonal skills, with experience working effectively on cross-functional teams.
• Familiarity with clinical trial design and experience authoring clinical trial protocols.
• Experience in the analysis and interpretation of clinical data and assessment of clinical relevance.
• Comprehensive understanding of safety profiles and risks.
• Ability to analyze and interpret complex datasets

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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