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Global Project Head - Early Neuro-Development

Company: Sanofi
Location: Cambridge
Posted on: November 16, 2023

Job Description:

JOB DESCRIPTIONThe Early Neuro-Development Global Program Head (GPH) is a key position that oversees early development activities in the Neurology & Ophthalmology Development (NOD) and 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 expand 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 and can be handed over to a later stage global program teams (GPT's). -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 regularly test in the clinic potentially disease-modifying treatments for Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP), Parkinson's Disease, Amyotrophic Lateral Sclerosis (ALS), and Genetic diseases such Metachromatic Leukodystrophy (MLD), as well as other CNS diseases. -Scientific excellence, integrative thinking and strong interpersonal skills will be required to succeed in this role. The Early Development GPH reports to Nazem Atassi, MD, Head of Early Neuro Development within NOD. The plan is for the incumbent to initially have one direct report although this will likely increase as the pipeline develops. 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 Early Neuro-Development 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 group. This role will require the ability to innovate and think creatively, engage multiple internal and external stakeholders, and make key decisions. -The GPH position requires achieving results through others and supporting the senior management team in achieving corporate goals. The GPH establishes the goals for the global project team (GPT) and participates in strategic planning for, and oversight of, the clinical and research activities of his/her area of responsibility. The GPH will be delegated such responsibilities as interaction with regulatory/health authorities, approval of protocols, informed consent documents, clinical study reports and product label. In addition, the GPH will be responsible for the communication strategy and scientific disclosures and travel authorizations, expense reports, and will interact with opinion leaders and consultants.Sanofi's Research and Development -Sanofi's specialty care is focused on four Therapeutic Areas: Rare and Rare Blood Diseases, Neurology & Ophthalmology Development (NOD), Immunology, and Oncology. 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 includes programs in Multiple Sclerosis, Neuroimmunology, Neurodegeneration, and Ophthalmology, with therapeutic modalities encompassing Small Molecules, Biologics, and Gene Therapy. - -Sanofi has a large internal research team in addition to the Genomic Medicine Unit (GMU), which are committed to building the future pipeline in various neurological and ophthalmological diseases. -Scientific and technical Expertise

  • Has and maintains deep scientific, technical and clinical expertise in Neurology
  • Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
  • Critically reads and evaluates relevant medical literature with deep understanding of the data and status from 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 task 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 goalsRegulatory responsibilities
      • Ensures clinical data meets all necessary regulatory standards
      • Supports registrations, label submissions and modifications
      • Manages Advisory Committee preparation and participation
      • Scientific data dissemination
      • Ensures timely submission and dissemination of clinical data
      • Supports the planning of advisory board meetings
      • Establishes and maintains appropriate collaborations with knowledge expertsIn addition to the above activities the GPH ensures that all activities of the GPT are conducted in compliance with current regulations, laws, and guidance from FDA, EMeA, and CHMP, as well as with Sanofi's policies and procedures.Basic Qualifications
        • Medical Doctor -
        • Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME)
        • More than 5 years of clinical or scientific, or more than > 10 years industry, experience within the field of the specific therapeutic area compounds
        • Fluent in English (verbal and written communication)Preferred Qualifications
          • Strong scientific and academic background with deep understanding of disease mechanisms -
          • Experience in or demonstrated evidence for the capacity to lead and manage groups of professionals
          • Strong leadership skills to manage international, cross-functional teams of highly skilled individuals
          • 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 health care 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 skillsSanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SA -#LI-SAAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Keywords: Sanofi, Cambridge , Global Project Head - Early Neuro-Development, Other , Cambridge, Massachusetts

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