Senior Medical Director, Clinical Development Neurology

About the role

We are looking for a Neurology medical expert who will be responsible for the clinical development of 2 or more programs. This therapeutic area role provides medical leadership and input to Program Teams across drug development, including transitioning molecules through IND/CTA and First in Human study stages to Proof of Concept/Phase 2, Phase 3, and regulatory approval. The position offers substantial opportunities to work with cross-functional project teams, serve on strategic teams (e.g., disease strategy team), and provide input to strategic decisions at the therapeutic area level.

Responsibilities

• Serve as subject medical expert and clinical development leader accountable for 2 (or more) programs, including preparation and execution of clinical development strategy and related documents such as protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Provide clinical development leadership for protocol execution, including interaction with investigators, data review, data analysis, and preparation of final clinical study reports.
• Offer strategic medical guidance to phase I/II/III development programs and oversee global patient clinical trials/trial teams in conjunction with Clinical Operations.
• Provide medical monitoring for assigned programs and assess safety events in collaboration with Safety teams.
• Represent the clinical team on cross-functional program teams, contributing medical input to integrated development plans.
• Develop medical content for regulatory documents and responses, including pre-IND, IND briefing packages, and common technical documents.
• Lead identification and external engagement with key opinion leaders for assigned programs, including advisory meetings, investigator meetings, and patient advocacy organizations.
• Foster the development of Medical Directors within the organization.
• Provide scientific and medical input (consultative services) to other R&D, commercial, translational, medicine, and business development functions; lead or oversee clinical activities to support due diligence.
• Work internally with other members of the Clinical Development Plan (CDP) to drive program strategy and CDPs.
• Coordinate communications and planning between medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology, and Medical Science) related to clinical development study design, execution, and interpretation of results.
• Drive awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Collaborate as part of a cross-functional team with colleagues from biostatistics, data management, clinical pharmacology, commercial, regulatory, and project management.

Requirements

• MD, DO, MBBS (or equivalent) degree with a relevant clinical specialty in the therapeutic area.
• 7+ years of clinical research expertise in neurological diseases with pharmaceutical/CRO industry experience in drug development.
• Excellent written and oral communication skills.
• Ability to think strategically and translate strategy into tactical plans to drive outcomes.
• Must be adaptable, able to prioritize, and manage time effectively.
• Willingness to take on new responsibilities and roles.
• Ability to work in an office environment, including using a computer, engaging in communications via phone/video/electronic messaging, problem-solving, collaboration, and maintaining general availability during standard business hours.
• Willingness to travel to scientific meetings.

Preferred Qualifications

• Specialty and/or practice, or development experience in Neuromuscular disease (especially gMG).
• Experience in Rare Disease, Gene Therapy, and/or Cell therapy.
• Board certification in Neurology.
• Publications (peer-reviewed) and presentations record.
• Experience preparing documents and attending regulatory meetings with regulatory agencies.
• Experience designing and completing multinational clinical trials.
• History of leading cross-functional teams to define clinical strategy and clinical study design.
• Experience supporting business development activities.
• Publications in peer-reviewed journals.

Benefits

Our positions offer eligibility for various incentives, including short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles. Benefits include qualified retirement programs, paid time off (vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Pay

The annual base pay for this position ranges from $288,059.20 to $432,088.80 USD annually.

Schedule

This is an in-office hybrid role with an expectation of working in the office a minimum of 3 days per week. The role balances the expectation of in-office presence with respect for individual flexibility.