Senior Medical Director Clinical Development Neurology

This is what you will do:

We are looking for a Neurology medical expert who will be responsible for the clinical development of neurology assets. This position offers substantial opportunities to work with cross-functional project teams.. This role is usually assigned to 2 or more programs, , serving on strategic teams (e.g., disease strategy team) and providing input to strategic decisions at the TA level.

This is a therapeutic area role and is specifically designated to provide medical leadership and input to Program Teams across drug development (i.e., transitioning molecule through IND/CTA and First in Human study stage to Proof of Concept /Phase2 stage, Phase 3 and regulatory approval ).

• Serve as subject medical expert and clinical development leader accountable for 2 (or more) programs, including but not limited to the preparation and execution of a clinical development strategy and related documents including 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, and contributing to data review, data analysis and the preparation of final clinical study reports.

• Provided strategic medical guidance to phase I/II/III development programs and oversight of global patient clinical trials/trial team (s) in conjunction with Clinical Operations on assigned program(s)

• Provide medical monitoring for assigned programs and assessment of safety events in conjunction with Safety teams

• Represent clinical team on the cross-functional program team accountable for medical input to integrated development plan

• Development of medical content for regulatory document, and responses (including but not limited to pre-IND, IND briefing packages and common technical documents)

• Lead identification and external engagement with key opinion leaders for assigned programs including at advisory meetings, investigator meetings and patient advocacy organizations

• Fostering development of Medical Directors in the

• Providing scientific and medical input (consultative services) to other R&D, commercial, translational, medicine and business development functions and leads or oversees clinical activities to support due diligences

• Working internally with other members of the CDP to drive program strategy and CDPs

• Coordinate communications and planning bet medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical Science) as it relates to clinical development study design, execution and interpretation of results.

• Driving 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

• Working as part of a cross-functional team with colleagues from biostatistics, data management, clinical pharmacology, commercial, regulatory and project management

• MD, DO, MBBS (or equivalent) degree with relevant clinical speciality for the the therapeutic area

• 7+ years clinical research expertise in neurological diseases with pharmaceutical/CRO industry experience in drug development

• Excellent written / 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

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

• Willing to travel to scientific meetings

• Specialty and/or practice, or development experience in Neuromuscular disease (gMG especially)

• Rare Disease, Gene Therapy and/or Cell therapy experience would be a plus

• Board certified in Neurology

• Publications (peer reviewed) and presentations record

• Experience preparing documents and attended 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

• Business development experience

• Publication in peer reviewed journals

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