Neurology Clinical Development Director

Alexion; Boston (MA); Hybrid; USD 288,000 - 432,000; Full time

Job summary

Alexion in the United States is seeking a Senior Medical Director, Clinical Development Neurology to lead the clinical development strategy for neurology assets across multiple programs, contributing to IND/CTA transitions and phase progression with cross-functional teams.

You will serve as medical expert, provide leadership for protocol execution, data review, safety assessment, and external engagement with key opinion leaders, while mentoring Medical Directors and collaborating with Global

Qualifications

• 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 travel to scientific meetings.

Responsibilities

• Serve as subject medical expert and clinical development leader accountable for 2 (or more) programs, including preparation and execution of a clinical development strategy and related 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 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.

Skills

Strategic thinking

Excellent communication

Adaptability

Travel willingness

Team collaboration

Problem solving

Education

MD/DO/MBBS (or equivalent)

Job description

Alexion in the United States is seeking a Senior Medical Director, Clinical Development Neurology to lead the clinical development strategy for neurology assets across multiple programs, contributing to IND/CTA transitions and phase progression with cross-functional teams.

You will serve as medical expert, provide leadership for protocol execution, data review, safety assessment, and external engagement with key opinion leaders, while mentoring Medical Directors and collaborating with Global