Senior/Executive Medical Director, Medical Monitor (Lexington)
The Role The Executive Medical Director, Medical Monitor is a key member of the Clinical Development team responsible for the planning, execution, analysis, and reporting of clinical studies. Serving as the medical monitor for Agenus programs, this individual provides scientific and medical leadership while maintaining accountability for the review, interpretation, and communication of clinical trial data. Working closely with cross-functional teams, the Executive Medical Director supports protocol development, study conduct, regulatory activities, and data-driven decision making. This is a highly hands-on role requiring sound medical judgment and a proactive, roll up your sleeves approach to advancing clinical development programs. In the role you will: Medical Monitoring & Patient Safety Act as Medical Monitor for assigned clinical trial(s), providing medical oversight to ensure patient safety, protocol compliance, and scientific integrity throughout study conduct. Provide medical oversight for ongoing safety surveillance, including timely review and assessment of adverse events, protocol deviations, eligibility questions, and other medical issues arising during study conduct. Evaluate evolving clinical data in situations where information may be incomplete or ambiguous, applying sound medical judgment to make timely decisions while clearly communicating scientific rationale, differing viewpoints, risks, and recommendations to cross-functional stakeholders. Clinical Development & Data Leadership Lead the ongoing review, curation, interpretation, and analysis of clinical trial data, ensuring data quality, completeness, consistency, and scientific integrity while identifying emerging efficacy and safety trends that inform development decisions. Develop and execute clinical data review plans and provide timely scientific interpretation of emerging data to internal teams and governance committees. Create and maintain clinical development plans aligned with target product profiles and broader program objectives, ensuring study-level decisions support the overall regulatory and registration strategy. Work closely with Clinical Operations, Data Management, and Biostatistics to optimize clinical data collection, CRF design, EDC functionality, data quality, and overall study execution. Scientific & Regulatory Leadership Author and/or review key technical and clinical documents, including clinical study protocols, investigator brochures, clinical study reports, annual reports, safety documents, and clinical sections of regulatory submissions. Participate in and prepare presentations for DSMBs, Steering Committees, Scientific Advisory Boards, investigator meetings, and other internal and external scientific forums. Assist in the preparation of abstracts, manuscripts, posters, and scientific presentations. Cross-Functional Collaboration Partner with Clinical Operations in the selection of investigators, clinical sites, and vendors (including CROs) and be accountable for the scientific execution of clinical protocols. Coordinate scientific activities across Regulatory Affairs, Translational Medicine, Clinical Operations, Pharmacovigilance, Biometrics, and other internal stakeholders to ensure efficient execution of clinical programs. External Engagement Build productive relationships with external scientific experts, investigators, and key opinion leaders. Leadership & Working Style Work independently while contributing effectively within a collaborative, interdisciplinary team environment. Maintain flexibility to meet deadlines and respond effectively to changing priorities in a fast-paced development environment. Qualifications MD or international equivalent with clinical research experience (5 years). Significant biotechnology and/or pharmaceutical industry experience serving in a Medical Monitor, Clinical Development, or equivalent sponsor-side clinical development role. Oncology drug development experience is required. Prior experience in immuno-oncology, immunotherapy, checkpoint inhibitors, or other immune-based therapies is strongly preferred. Experience leading clinical development programs from early-phase development through late-stage and registrational studies, including Phase 3 trials and contributions to global regulatory submissions (e.g., BLA, NDA, or MAA). Experience taking ownership of a clinical development program from study design through database lock, clinical study report, regulatory submission, and health authority interactions, rather than isolated experience across multiple studies. Broad and solid understanding of drug development, including preclinical research, clinical operations, regulatory affairs, pharmacovigilance, biometrics (biostatistics and data management), and drug supply. Hands-on experience reviewing, interpreting, and analyzing clinical trial data with accountability for the scientific quality, integrity, and communication of study results. Ability to understand, interpret, and communicate complex clinical information, literature, competitive intelligence, and evolving treatment paradigms to support robust clinical development strategies. Excellent written and verbal communication skills with the ability to influence cross-functional teams and effectively communicate complex scientific concepts. Ability to make sound medical decisions in ambiguous situations, reconcile differing scientific opinions, and communicate evidence-based recommendations to senior leadership and cross-functional stakeholders. Critical traits for success include strategic thinking, scientific curiosity, strong analytical skills, decisiveness, sound medical judgment, attention to detail, and the ability to influence without direct authority. Ability to work independently, prioritize effectively, and manage multiple complex initiatives simultaneously. Self-motivated, detail-oriented, and comfortable working in an entrepreneurial, fast-paced biotechnology environment where a hands-on approach is expected. J-18808-Ljbffr
