Senior Global Project Head, Neurology Development

Sanofi•Morristown, NJ

44d

About The Position

Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. The Senior Global Project Head (Sr GPH), Neurology Development role is a key position that leads early development activities in Neurology Development. The Sr GPH is responsible for shaping strategy as well as managing execution. This is a highly visible role that will work closely with the Research and Development Heads in the Therapeutic Area to build and renew the early portfolio in Neurology. Unlike other GPH roles, this role is focused on multiple projects from IND-enabling studies to first-in-human studies and successful proof-of-concept trials. New programs come from the internal research pipeline and from in-licensing. The Early Development GPH is a critical contributor for the selection of projects to move forward and will drive execution of projects until they have achieved proof of concept. In some cases, the GPH may transition to lead a later-stage development program. At Sanofi, we chase the miracles of science. Sanofi believes that the more we understand about disease pathogenesis in the human nervous system, the greater the chance we can produce life-changing therapies. Over the next five years, Sanofi plans to test in the clinic potentially disease-modifying treatments for diseases such as Multiple Sclerosis (MS), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Alzheimer's Disease (ALZ), Parkinson's Disease (PD), Amyotrophic Lateral Sclerosis (ALS), as well as other CNS diseases. This Sr GPH role is focused on neurodegenerative diseases and particularly Alzheimer's Disease. Scientific excellence, integrative thinking, and strong interpersonal skills will be required to succeed. The Sr GPH reports to the TA Head, NOD. The impact on the organization is extensive due to the ability to influence disease area strategy and the network of collaborators from preclinical research to operational, regulatory, and commercial functions. Success in this role requires the ability to influence and lead at the highest possible level. The Sr GPH will be a critical member of the NOD leadership team and will be joining at a key point in time with the opportunity to build and influence the group. This role will require the ability to innovate and think creatively, engage multiple internal and external stakeholders, and make key decisions. The Sr GPH position requires achieving results through others and supporting the senior management team in achieving corporate goals. The Sr GPH establishes the goals for the global project team (GPT) and participates in strategic planning for, and oversight of, the clinical activities of his/her area of responsibility. The GPH will be responsible for interaction with regulatory authorities, approval of protocols, informed consent documents, clinical study reports, and product labels. In addition, the GPH will be responsible for the communication strategy and scientific disclosures, travel authorizations, and expense reports, and will interact with opinion leaders and consultants. Sanofi's Key Therapeutic Areas (TAs) include Immunology, Neurology & Ophthalmology Development (NOD), Rare and Rare Blood Diseases, and Vaccines. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world. The NOD TA includes programs in Neuroimmunology, Neurodegeneration, and Ophthalmology, with therapeutic modalities encompassing Small Molecules, Biologics, and Gene Therapy. Sanofi has an internal research team, in addition to the Genomic Medicine Unit (GMU), which is committed to building the future pipeline. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Requirements

Bachelor's Degree required. Medical Doctor preferable, or PhD in relevant area
10 years of business-related experience is required
6+ years of experience in drug development within a therapeutic area is required
Deep expertise in Early Development (Translational Medicine) is required
Strong leadership skills to manage international, cross-functional teams of highly skilled individuals
Experience in or demonstrated evidence for the capacity to lead and manage groups of professionals
Excellent communication skills
Fluent in English (verbal and written communication)
Travel up to 25% is required

Nice To Haves

Strong scientific background with deep understanding of drug development; background in clinical development for Neurology is highly preferred
Good networking ability in cross-cultural environment
Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
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
Strategic thinking in combination with understanding science and technologies
Performance-oriented with ability to work along agreed timelines and a focus on strategy and execution
Outstanding communicator. Excellent problem-solving, conflict-resolution, and decision-making skills

Responsibilities

Scientific and Technical Expertise
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
Management and Career Development
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
Regulatory Responsibilities
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
In addition to the above activities, the Sr GPH 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.

Benefits

Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

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