Clinical Research Director, Neurology (Early Development)

Job Title: Clinical Research Director

Location: Cambridge, MA,

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

This Clinical Research Director (CRD) role in the Neurology Clinical Development department is for a clinical expert of Alzheimer’s disease and is responsible for leading the development of clinical stage assets for treating Alzheimer’s disease. More specifically,CRD is responsible for developing the clinical development plan, designing and executing clinical trials, analyzing trial data, interacting with regulatory agencies, and participating in internal decision making. CRD will work closely with the Global Project Head, Research Scientist, Clinical Pharmacologist, Biomarker Lead, Safety Medical Director, Statistician, Regulatory and other key functional leads. The role requires a strategically and operationally focused, resourceful, and well-organized individual with strong self-motivation, scientific excellence, outstanding interpersonal and analytical skills, and the ability to achieve multiple objectives and goals in parallel.

 

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. Sanofi has a large internal research team including the Genomic Medicine Unit (GMU), which are committed to building the future pipeline in various neurological and ophthalmological diseases. Over the next five years, the Neurology & Ophthalmology Development (NOD) group plans to regularly test in the clinic potentially disease-modifying treatments for Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP), Alzheimer’s disease, Parkinson’s disease, Amyotrophic Lateral Sclerosis (ALS), as well as other CNS diseases, with therapeutic modalities encompassing Small Molecules, Biologics, and Gene Therapy.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Responsibilities:

 

Leading the clinical development plan strategies:

• Responsible for the clinical development plans and clinical sections of integrated development plans (IDP).

• Contribute to the development of the product value proposition (TVP), target product profile (TPP), market access strategy, and the research strategy.

• Collaborate with other CRDs to ensure leadership and coordinate action plans with stakeholders to resolve project-related study issues, anticipate potential risks, and share lessons learned across the project or study teams.

• Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators.

• Evaluates relevant medical literature and status from competitive products.

 

Lead, support and oversee the execution of clinical development plan and study activities:

• Draft and Review study protocols and protocol amendments.

• Review/approve study-related documents (e.g., informed consent form, vendor specifications for centralized services, case report form [CRF], CRF completion guidance, patient diary, etc.).

• Develop training materials and lead investigator meetings.

• Answer to medical questions raised by Ethics Committees (ECs)/Institutional Review Boards (IRBs) and sites.

• Assisted by related functions (e.g., clinical operations, project management, and procurement), responsible for timelines, budget, and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs).

• Lead the study specific committees, e.g., Independent Data-Monitoring Committee (IDMC), study steering committee, adjudication committee, with operational support.

• Co-Develop the SAP in collaboration with biostats.

• Participate in medical review of aggregated data in ongoing trials, e.g., safety and stat outputs of blinded data.

• Develop the Clinical Study Report (CSR). Responsible for key results preparation.

 

Responsibilities related to regulatory submission and interactions:

• Review and/or contribute to the clinical section of the Investigator’s brochure, Clinical Trial Application (CTA), Investigational New Drug (IND), Risk Management Plan (RMP), etc.

• Contribute to briefing packages for regulatory meetings.

• Lead discussion at meetings with regulatory agencies.

• Ensure clinical data meets all necessary regulatory standards.

 

Scientific Data evaluation and authorship:

• Participate and author manuscripts and congress abstracts.

• Support or lead advisory board meetings.

• Establish and maintain appropriate collaborations with knowledge experts.

• Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates and serves as the clinical advisor to research teams.

 

About You

Qualifications:

• Medical Doctor (MD) required, and a neurologist with clinical research experience in Alzheimer’s disease is highly desired.

• Understanding of pharmaceutical product development and life cycle management gained through a minimum of 2 years of industrial experience or 5 years of relevant academic experience.

• Deep expertise in clinical development and methodology of clinical studies.

• Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with regulatory agencies.

• Fluency in written and spoken English.

• Excellent teaching skills with demonstrated ability to train others.

• Ability to work within a matrix model.

Why 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.

Sanofi 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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.