Senior Medical Director Clinical Development Neurology

AstraZeneca•Boston, MA

64d•Hybrid

About The Position

This is what you will do: We are looking for a Neurology and Gene Therapy 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 ). You will be responsible for:

Requirements

MD, DO, MBBS (or equivalent) degree with relevant clinicanl 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 manmage 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

Nice To Haves

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

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 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