Senior Global Project Head, Neurology Development

Role Summary

Senior Global Project Head, Neurology Development leads early development activities in Neurology Development and shapes strategy while managing execution. This highly visible role works with Research and Development Heads to build and renew the early portfolio, focusing on multiple projects from IND-enabling studies to first-in-human studies and proof-of-concept trials, with potential transition to later-stage development. Location: Cambridge, MA; Morristown, NJ. Travel up to 25% may be required.

Responsibilities

• Deep scientific, technical, and clinical expertise in Neurology; deep expertise in neurodegenerative diseases, especially Alzheimer's disease, preferred
• Understands and stays 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 lifecycle 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, 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 all necessary 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 GPT activities are conducted in compliance with current regulations, laws, and guidance from FDA, EMA, CHMP, as well as Sanofi policies and procedures

Qualifications

• Required: Bachelor's Degree; Medical Doctor preferable, or PhD in relevant area
• 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 capacity to lead and manage groups of professionals
• Required: Excellent communication skills
• Required: Fluent in English (verbal and written communication)
• Required: Travel up to 25% is required
• Preferred: Strong scientific background with deep understanding of drug development; background in clinical development for Neurology is highly preferred
• Preferred: Good networking ability in cross-cultural environment
• Preferred: Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
• Preferred: In-depth knowledge of global drug development activities including the development of other healthcare solutions along the whole value chain from research up to market access. Skilled in project and/or budget/resource management
• Preferred: Strategic thinking in combination with understanding science and technologies
• Preferred: Performance-oriented with ability to work along agreed timelines and a focus on strategy and execution
• Preferred: Outstanding communicator. Excellent problem-solving, conflict-resolution, and decision-making skills