Medical Director, Clinical Development

Summary

Join REGENXBIO as the Medical Director, Clinical Development (CNS & Neuromuscular) to lead the development of a groundbreaking gene therapy for MPS II and future programs. You will be responsible for the clinical strategy, cross-functional collaboration, and regulatory compliance. This role requires strong leadership, expertise in clinical trials and drug development, and experience with gene or cell therapies. You will represent the clinical perspective to senior management and external stakeholders, ensuring the successful progression of the drug candidate from pre-clinical stages through launch. The position involves significant collaboration and requires up to 25% travel. REGENXBIO values trust, accountability, perseverance, and innovation.

Requirements

• M.D., Ph.D. or PharmD
• Proven track record of experience and leadership in clinical trials/drug development
• Practical experience including, development of clinical investigational protocols, implementation of protocols, interpretation of data, and interactions with regulatory bodies
• Excellent leadership skills
• Deep knowledge of drug development from end to end
• Ability to manage multiple and diverse internal/external collaborations at different stages of development
• The ability to work well under intense pressure, tight timelines, and in rapidly changing situations
• Evidence of an entrepreneurial spirit and a capacity to find creative solutions to unexpected hurdles
• Interact effectively across boundaries with supporting REGENXBIO functions and disciplines using influencing, communication and relationship building skills
• Commitment to anticipate, influence and direct change
• Excellent listening and collaboration skills

Responsibilities

• Be accountable for clinical strategy, including the clinical development plan, and coordination of cross-functional execution of clinical strategy by the clinical sub teams
• Work in collaboration with external and internal experts to generate innovative development plans that create the best balance of time, resource and risk while ensuring the proposed plans align with the overall corporate strategy
• Represent clinical on the cross-functional program core team
• Be accountable for clinical input and clinical sections of the Product Development Plan
• Be accountable for clinical project timelines
• Serve as the clinical core team representative presenting clinical development plans and recommendations to senior management and key stakeholders
• Chair the Internal Safety committee monitoring clinical safety of clinical studies
• Be accountable for overseeing medical monitoring to clinical studies
• Lead and/or participate in clinical/medical advisory panels and investigator meetings
• Contribute as author and provide clinical review of protocols, clinical study reports and publications
• Provide support to publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals
• Remain up-to-date with current information on regulations, guidelines, and practices and therapeutic area knowledge and ensure consistent best practice across all activities
• Provide credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas
• Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions
• Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders
• Be accountable for the adherence to Good Clinical Practice, data integrity principles and other key REGENXBIO policy requirements by external and contract partners
• Travel up to 25% of the time

Preferred Qualifications

Experience with gene or cell therapies and/or rare orphan diseases