Senior Director, Medical Director

Role Summary:

The Senior Director, Medical Director serves as a key member of the DM1 clinical team

leadership and has primary responsibility for the execution of the integrated development strategy, including both in-house development and potential strategic partnerships to augment the internally developed pipeline. The Senior Director, Medical Director is responsible for the development of the medical aspects of the program. This role is responsible for delivering quality and timely medical input and interpretation on specific program data in fulfilment of the program objectives, working in partnership with regulatory affairs and pharmacovigilance in providing medical support for pharmacovigilance activities, responses to regulatory agency queries, and development.

This role is based in Waltham, MA with the possibility of being a hybrid role.

Primary Responsibilities Include:

• Partner with the DM1 Clinical Development Lead to guide the Clinical Development team across the planning, design, development, and implementation of clinical trials for a drug candidate.
• Develop knowledge of disease mechanisms to select biomarkers, pharmacodynamic endpoints, and patient stratification considerations.
• Contribute to the development and implementation of an effective, timely, and cost-efficient program to establish the safety and efficacy of drug candidates for approval in the US and other countries.
• Collaborate across departments, including Discovery, Clinical Operations, and external collaborators, to ensure smooth transitions of development candidates from research into clinical development, and oversee the execution of clinical trials according to all applicable regulations and guidelines (GCP, ICH).
• Identify, manage, and interface with external collaborators and key opinion leaders to create clinical development strategies for novel therapeutics.
• Provide clinical development oversight and input, including writing and reviewing key documents such as protocols, investigator brochures, and informed consent forms, while ensuring the integration of product and clinical development plans.
• Manage relationships with third parties such as CROs and collaborative partners to support clinical development efforts and implement chosen outsourcing or in-house approaches.
• Serve as a medical representative to regulatory agencies, investigators, advisors, and as study medical monitor, as needed, co-representing the company in regulatory interactions.
• Guide the Research team on decisions with clinical implications and support the writing of protocols, presentations, publications, and regulatory submissions.
• Develop and implement SOPs for clinical trials and ensure compliance with all applicable regulatory standards for global clinical trials and interactions with physicians.
• Provide leadership and mentorship to clinical development team members, manage matrix and direct line reports, and support the Clinical Development Lead in oversight of the department budget and financial planning.
• Maintain accountability for timelines and deliverables by coordinating with internal departments (e.g., Finance, Regulatory Affairs, Legal, Medical Affairs) and external vendors. Provide timely updates on progress and changes in scope, schedule, and resources as needed.
• Participate in Business Development due diligence and presentations to external stakeholders.
• Develop and maintain professional relationships with academic and community-based study sites.

Education and Skills Requirements:

• Doctor of Medicine degree, PhD, or Pharm. D., with a strong scientific background and a specialty in neurology or neuroscience training highly preferred
• Minimum of 12 years of pharmaceutical industry experience, including leading clinical development programs in Neurology/Neuromuscular disorders
• Experience managing drug development from Phase 1 through Phase 3 trials
• Comprehensive experience with Pre-INDs, INDs, CTAs, EOP 2 meetings, NDA/BLAs/MAA submissions (both US and ex-US)
• Strong knowledge of FDA and ICH regulations, along with expert knowledge of Good Clinical Practice (GCP)
• Proven ability to design, execute, monitor, and manage clinical trials across all phases of development
• Readiness to contribute hands-on to team efforts and inspire high-performance clinical teams
• Skilled in working in a matrix environment, building consensus, and driving successful outcomes across departments and stakeholders
• Ability to lead cross-functional meetings and collaborate with senior leaders and external stakeholders
• Ability to translate basic science into product development plans that maximize commercial opportunity
• Develop creative approaches to processes, practices, and strategies
• Effectively prioritize near- to long-term efforts for impactful results
• Exceptional writing and verbal communication skills, with a proven track record of publications and polished presentations
• Ability to effectively influence internal and external audiences with clear communication
• Takes personal accountability for outcomes and thrives on increasing levels of responsibility
• Consistently drives key actions with independence and high effectiveness
• Experience in a small to mid-sized biotech company preferred, with demonstrated readiness to adapt and excel in dynamic environments

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