Senior Medical Director

Replimune; Woburn (MA); On-site; USD 200,000 - 300,000; Full time

Job summary

Replimune seeks a Senior Medical Director for Clinical Development to drive drug strategy and oversee clinical studies in oncology. The role encompasses various responsibilities, such as regulatory collaboration and patient safety, aiming for successful market entry and compliance.

Qualifications

• M.D. degree required; PhD preferred with essential oncology experience.
• At least 5 years global clinical development experience in oncology.
• Excellent communication skills necessary.

Responsibilities

• Lead clinical strategy and oversee study design and conduct.
• Ensure compliance with GCP and interpret clinical data.
• Represent company in regulatory meetings with FDA and EMA.

Skills

Clinical trial design

Oncology knowledge

Communication

Collaboration with KOLs

Regulatory knowledge

Medical monitoring

Education

M.D. degree

PhD in related field (preferred)

Oncology board certification (strongly preferred)

Tools

Word

PowerPoint

Excel

Project

Job description

Overview

Reporting to the VP Clinical Development (VPCD), the Senior Medical Director, Clinical Development (SDCD) will support the implementation of Replimune's drug development strategy. The role involves leading and supporting various aspects of individual drug programs, including clinical study conduct, collaboration with cross-functional teams, and providing clinical expertise in protocol development, regulatory interactions, patient enrollment, safety monitoring, data analysis, and scientific communication. The SDCD will act as both an internal leader and external representative, engaging with clinical sites, partners, and stakeholders.

Responsibilities

Key responsibilities:

• Contribute to the clinical strategy for Replimune's programs from early development through post-marketing, focusing on mid to late stages.
• Serve as the clinical lead and main point of contact for assigned programs and trials, overseeing study design, protocol development, and study conduct.
• Ensure scientific accuracy and relevance in study concepts and protocols, and review related documentation such as monitoring plans, SAPs, amendments, and regulatory submissions.
• Provide medical oversight for clinical studies, including safety monitoring, risk assessment, and investigator relationships.
• Collaborate with development teams to interpret clinical data, support regulatory submissions, and ensure compliance with GCP and regulatory standards.
• Represent the company in meetings with regulatory agencies like the FDA and EMA, and contribute to regulatory documents and responses.
• Support clinical trial site evaluation, investigator engagement, and strategic planning for clinical programs.
• Coordinate with Medical Affairs and other teams to develop educational materials and stay informed on industry developments.
• Ensure clinical activities are conducted ethically, within scope, budget, and timeline, and support business development efforts.

Other responsibilities:

• Maintain compliance training and contribute to quality initiatives.
• Assist in developing commercialization strategies, including post-marketing studies.
• Participate in internal and external committees as required, and mentor junior staff.

Qualifications

Educational requirements:

• M.D. degree required; PhD preferred. Oncology and immunotherapy experience essential.
• Oncology board certification strongly preferred.

Experience and skills:

• At least 5 years of global clinical development experience, particularly in oncology.
• Strong knowledge of clinical trial design, management, and regulatory requirements.
• Experience leading Phase 1-3 oncology programs, with regulatory and commercial success.
• Excellent communication skills and ability to collaborate effectively with KOLs, investigators, CROs, and regulatory agencies.
• Knowledge of international compliance standards, FDA, EMA, and other regulatory bodies.
• Experience in medical monitoring, vendor management, SOP development, and strategic partnerships.
• Proficiency with computer tools like Word, PowerPoint, Excel, and Project.
• Willingness to travel domestically and internationally (~30%).