Senior Global Project Head, Neurology Development

Role Summary

Senior Global Project Head, Neurology Development leads early development activities in Neurology Development. The role shapes strategy and manages execution for multiple projects from IND-enabling studies to first-in-human trials and proof-of-concept. It works closely with Research and Development Heads in the Therapeutic Area to build and renew the early portfolio, and may transition to lead later-stage development programs. Location: Cambridge, MA; Morristown, NJ.

Responsibilities

• Has and maintains deep scientific, technical, and clinical expertise in Neurology.
• Deep expertise in neurodegenerative diseases, especially Alzheimer's disease, is preferred.
• Understands and keeps up to date with preclinical, clinical pharmacology, and other data relevant to the molecule of interest.
• Critically reads and evaluates relevant medical literature with deep understanding of the data and status for competitive products.
• Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders.
• Oversees development planning, execution, and budget.
• Owns the overall program strategy and leads the international cross-functional team to meet program objectives.
• Participates in life cycle management strategy planning in collaboration with marketing teams.
• Proposes strategies for interactions with health authorities.
• Establishes project goals in alignment with functional resource allocation, goals, and objectives.
• Responsible for generating support and implementation of clinical studies.
• Ensures operational plans are integrated across all functions.
• Is responsible for annual budget deliverables.
• Ensures that team members are adequately qualified and trained in the tasks they are required to perform, including accountability and maintaining compliance training for direct reports.
• Works cross-functionally to select appropriate team members.
• Sets team's objectives and works closely with direct reports to create individual performance and development goals.
• Ensures clinical data meets regulatory standards.
• Supports registrations, label submissions, and modifications.
• Manages Advisory Committee preparation and participation.
• Ensures timely submission and dissemination of clinical data.
• Supports the planning of advisory board meetings.
• Establishes and maintains appropriate collaborations with knowledge experts.
• Ensures that all activities of the GPT are conducted in compliance with current regulations, laws, and guidance from FDA, EMA, and CHMP, as well as with Sanofi's policies and procedures.

Qualifications

• Required: 10 years of business-related experience
• Required: 6+ years of experience in drug development within a therapeutic area
• Required: Deep expertise in Early Development (Translational Medicine)
• Required: Strong leadership skills to manage international, cross-functional teams of highly skilled individuals
• Required: Experience in or demonstrated evidence for the capacity to lead and manage groups of professionals
• Required: Excellent communication skills
• Required: Fluent in English (verbal and written communication)

Education

• Bachelor's Degree required. Medical Doctor preferable, or PhD in relevant area

Additional Requirements

• Travel up to 25% is required