Sr. Medical Director, Clinical Development

Replimune•Woburn, MA

19h•$318,000 - $411,500

About The Position

The Senior Medical Director, Clinical Development assists in implementing Replimune’s drug development strategy and leads or contributes to individual drug programs. The role leads or supports clinical studies and works closely with clinical development, program leadership, biometrics, clinical operations, safety and pharmacovigilance, regulatory, molecular diagnostics, and translational research teams. It provides clinical input on protocol development, regulatory interactions, patient enrollment, safety monitoring and review, biomarker development, data analysis, manuscripts, and presentations at national and international meetings. The role also works with clinical operations on site evaluation and selection, and may collaborate with preclinical teams and strategic or collaboration partners. The position contributes to clinical strategy for selected programs from early development through regulatory submissions and post-commercialization, with emphasis on mid- to late-stage development. As the clinical lead for assigned programs and trials, the Senior Medical Director guides study design and conduct, provides medical oversight, interprets clinical and translational data, and supports regulatory filings and agency interactions. The role ensures that programs comply with GCP and applicable regulatory, local, and institutional requirements, while meeting milestones, budgets, and timelines. The Senior Medical Director also supports tactical trial-program development, investigator-sponsored study prioritization, business development, commercialization strategy, and educational materials. The role may participate in internal and external committees, recruit and mentor employees, and support team training and professional development. Domestic and international travel of up to approximately 30% is required.

Requirements

Medical degree (M.D.).
Training and experience in oncology and immunotherapy.
At least 7 years of global clinical development experience and success in biotech or pharmaceutical companies.
Professional knowledge and skills in solid-tumor oncology.
Strong understanding of clinical development fundamentals, including protocol development and follow-up, study monitoring, data collection and analysis, database cleaning, and database lock.
Demonstrated experience designing development strategies, including biomarker strategy, and leading Phase 1–3 programs, with relevant regulatory and commercial experience in oncology drug approval and launch.
Demonstrated familiarity with biostatistical principles used to analyze and interpret clinical trial data.
Ability to interface effectively with key opinion leaders, investigators, CROs, and other entities.
Excellent written and verbal scientific communication skills and analytical abilities.
Knowledge of international compliance guidelines and regulations, FDA, EMA, and PMDA requirements and expectations, GCP, ICH guidelines, and clinical drug development.
Experience representing a sponsor before regulatory agencies.
Knowledge of day-to-day clinical trial medical monitoring, including responding to patient eligibility and protocol-waiver questions, reviewing safety parameters, working with Pharmacovigilance on SAEs and SAE narratives, and IND expedited safety reports.
Prior experience with vendor selection and management.
Experience developing and supporting related SOPs and policies.
Experience with partnerships and strategic alliances.
Skilled in computer-based tools, including Word, Project, PowerPoint, and Excel.
Ability to travel domestically and internationally up to approximately 30%.

Nice To Haves

Additional science degree (Ph.D.).
Oncology board certification.
Knowledge of all requirements and processes for taking a drug candidate through clinical development to registration.
Experience in late-stage medical affairs and commercial environments, including planning and participation in pre-commercial activities for late-stage to commercial products.

Responsibilities

Contribute to clinical strategy for assigned programs from early development through regulatory submissions and post-commercialization, with emphasis on mid- to late-stage development.
Serve as clinical lead and point person for assigned programs and trials from initiation through discontinuation.
Lead or facilitate cross-functional clinical development and study teams.
Design studies aligned with clinical strategy and drive preparation and approval of study synopses and protocols and the conduct of clinical studies.
Ensure the scientific and medical basis of studies is relevant and accurate through scientific review and consultation with internal and external experts.
Organize consultations with global opinion leaders and contribute to or lead advisory board meetings.
Review and finalize clinical study concepts, protocols, and amendments, and review or edit related documents, including monitoring plans, statistical analysis plans, IRB/IEC submissions, and regulatory submissions.
Oversee cross-functional study teams and provide medical guidance to clinical study teams.
Conduct medical monitoring with CRO, pharmacovigilance, biostatistics, clinical operations, and program leadership, including assessing study-conduct issues, subject safety, and program, trial, or data risks and implementing mitigation strategies.
Maintain and develop relationships with key study investigators.
Provide medical input and guidance to development and study teams; collaborate across functions to deliver trial data, assure data integrity, and consolidate trial-progress information.
Direct interpretation of clinical and translational study data, present findings to internal governance or management, and help determine implications for compound strategy.
Author or contribute to clinical sections of regulatory communications and documents, participate in agency meetings, and support clinical study reports, DSURs, PSURs, regulatory submission sections, investigator brochures, and responses to regulatory questions.
Ensure clinical activities and programs comply with GCP, regulatory requirements, and local and institutional requirements.
Work with Regulatory and cross-functional teams to prepare high-quality, timely submissions to the FDA and other health authorities, and represent Clinical at meetings with the FDA, EMEA, and other agencies.
Work with program management to integrate objectives, achieve milestones on schedule, and use resources effectively across functions.
Support tactical clinical trial program development, including prioritization of investigator-sponsored studies and literature reviews.
Collaborate with Medical Affairs on medically accurate educational materials for stakeholders, including healthcare providers and patients.
Track competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and reviewing literature.
Promote state-of-the-art scientific and ethical methods in the design of high-quality clinical trials.
Help ensure clinical development activities are compliant, meet global industry standards, and remain within scope, budget, and timelines.
Collaborate with research and preclinical development to advance product candidates into clinical investigations.
Support business development by evaluating product candidates, determining indications, and contributing to strategic planning and partnering discussions.
Complete and maintain compliance training, provide input on initiatives and procedures, and assist with compliance and quality training materials.
Work with Commercial on commercialization strategy, including target product profiles, competitive assessment, target positioning, alignment of clinical and commercial strategies, and potentially post-marketing studies.
Serve on internal committees or represent Replimune on external committees and foundations when asked.
Assist with recruiting, mentor junior team members, contribute to training materials, and support new hires’ professional development.
Perform other duties as assigned.