Senior Global Project Head, Neurology Development

11 hours ago


Cambridge, United States Massachusetts Staffing Full time

Senior Global Project Head, Neurology DevelopmentJoin 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) in Neurology, with a focus on multiple sclerosis, is a key position that oversees critical development activities in the Neurology & Ophthalmology Development (NOD) Therapeutic Area (TA). The Sr GPH is responsible for shaping strategy as well as managing execution. This highly visible role will work closely with the TA Head to build and expand the portfolio in Neurology. This role is focused on leading a global program team (GPT) responsible for a Phase 3 stage multiple sclerosis program. The Sr GPH should also contribute to the strategy and development activities end-to-end from research to clinical stage assets for neuroimmunology and multiple sclerosis. At Sanofi, we chase the miracles of science. Sanofi believes that the more we understand disease pathogenesis in the human nervous system, the greater the chance we can produce life-changing therapies. Sanofi plans to regularly test in the clinic potentially disease-modifying treatments for diseases such as Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP), Parkinson's Disease, and Alzheimer's disease. Scientific excellence, integrative thinking, and strong interpersonal skills will be required to succeed in this role. The plan is for the incumbent to have a senior role and manage several direct reports of medical directors and clinical scientists. The impact on the organization is extensive due to the ability to lead program strategy and the network of collaborators from 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 a 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 GPT and leads the strategic planning for, and oversight of, the clinical and other activities of his/her area of responsibility. The Sr GPH responsibilities will include interactions with regulatory authorities, approval of protocols, informed consent documents, clinical study reports, and product labels. In addition, the Sr 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 key Therapeutic Areas (TAs) include Immunology, Vaccines, Neurology & Ophthalmology Development (NOD), Rare and Rare Blood Diseases, 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 for patients and their families around the world. The NOD TA includes programs in Multiple Sclerosis, 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 in neurological and ophthalmological diseases.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.Main Responsibilities(60%) Scientific and Technical LeadershipMaintains advanced scientific, technical, and clinical expertise in Neurology.Reviews and analyzes pre-clinical, clinical pharmacology, and molecular data on a weekly basis to inform program strategyConducts critical evaluation of medical literature monthly, providing comprehensive competitive intelligence reports to leadership teamMaintains visibility within the therapeutic area through quarterly participation in scientific conferences and monthly engagement with key opinion leadersDirects development planning, execution, and manages program with annual budgets ranging from $50-100 millionDevelops and implements overall program strategy while leading international cross-functional teams of currently 8 direct reports, and 10-15 other key teams members from other functions, to achieve program milestonesCoordinates life cycle management strategy planning quarterly in collaboration with marketing teamsFormulates and presents strategies for health authority interactions, including FDA and EMA meetingsEstablishes specific project goals monthly in alignment with functional resource allocation and corporate objectivesOversees generation and implementation of clinical studies, managing 3-5 concurrent Phase II/III trialsCoordinates operational plans across all functions on a bi-weekly basis through cross-functional team meetingsManages and delivers annual budget targets with accountability for cost control and resource optimization(20%) Management and Career DevelopmentValidates that team members possess required qualifications and training through quarterly competency assessments, maintaining 100% compliance training completion for 5-8 direct reportsCollaborates cross-functionally to recruit and select appropriate team members for specialized rolesEstablishes team objectives quarterly and conducts monthly one-on-one meetings with direct reports to develop individual performance and career development goals(10%) Regulatory ResponsibilitiesReviews and validates clinical data compliance with FDA, EMA, and ICH regulatory standards through weekly data review meetingsCoordinates registrations, label submissions, and modifications with regulatory teams on established timelinesDirects Advisory Committee preparation activities and participates in regulatory meetings as company representativeMonitors timely submission and dissemination of clinical data according to regulatory timelinesCoordinates planning of advisory board meetings quarterly with key opinion leadersDevelops and maintains strategic collaborations with external knowledge experts and academic institutions(10%) ComplianceVerifies 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 through monthly compliance audits and quarterly regulatory assessments.About YouRequired QualificationsMedical Doctor (MD) required.Minimum of 10 years of clinical, scientific, or industry experience required, preferably within the field of neurologyFluent in English (verbal and written communication)Ability to travel up to 25% domestic and international required, including for scientific congresses, health authority meetings, advisory boards, investigator/site meetings and internal meetings. Approximately 50% domestic, 50% international.Preferred QualificationsStrong scientific and academic background with deep understanding of disease mechanisms, including in-depth understanding of neuroimmunology diseasesExperience in or demonstrated evidence for the capacity to lead and manage groups of professionalsStrong leadership skills to manage international, cross-functional teams of highly skilled individualsGood networking ability in cross-cultural environmentStrong interpersonal, communication, presentation, and negotiation skills across all levels of the organizationIn-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 managementStrategic thinking in combination with understanding science and technologiesPerformance-oriented with ability to work along agreed timelines and a focus on strategy and executionOutstanding communicator. Excellent problem-solving, conflict-resolution, and decision-makingWhy Choose Us?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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