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 neurology assets. This position offers substantial opportunities to work with cross-functional project teams.

Responsibilities

• 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 between 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

Requirements

• 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

Qualifications

• 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

Benefits

We would prefer for you to have:

• 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 would be a plus
• 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
• Publishation in peer reviewed journals

Pay

The annual base pay for this position ranges from 288,059.20 - 432,088.80 USD Annual . Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Schedule

This role has an expectation of working in the office a minimum of 3 days a week. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility.