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Clinical Research Director, Neurology

Cambridge, Massachusetts

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Overview

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Success Profile

Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Results-driven
  • Proactive
  • Problem-Solver
  • Leadership
  • Team player

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Culture: Play to Win

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    Growth

  • Scientists discussing lab work

    Innovation

  • Doctor using new technology

    Efficiency

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    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.

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 MS/Neurology/Gene Therapy therapeutic area to maintain credibility with internal and external stakeholders

On Clinical Development, the Clinical Research Director

  • Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes

  • Assessment of the Clinical benefit –risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team

  • Provides clinical input to the Target Product Profile

  • Adjusts and updates the clinical strategy when necessary according to the project progression and information available

  • Contributes to the life cycle management strategy for the project whenever appropriate

The Clinical Research Director is representative for Clinical Development

  • at the Project Team

  • in meetings with Regulatory Agencies

  • in Steering Committees (SC) and Data Monitoring Committees (DMC) (only “open” part of the DMC meetings)

  • at the Benefit Risk Assessment Committee

  • at the Submission Task Force. Provides clinical input and reviews the product information (Summary of Product Characteristics or equivalent

The Clinical Research Director generates documents

  • Generates the Clinical Development Plan (phase 2, 3 and 3b depending on the project status)

  • Prepares the clinical part of meeting requests and briefing packages for meetings with Regulatory agencies

  • For phase 2, 3 and 3b clinical studies generates the extended synopsis and reviews the protocols and protocol amendments prepared by the Clinical Study Director (CSD)*

  • Writes or updates the clinical section of the Clinical Investigator Brochure and the clinical parts of the Clinical Trial Authorization dossier (IMPD, IND) in collaboration with the pharmacovigilance (GPE) department and the clinical pharmacologist

  • Reviews and when appropriate approves the committees charters

  • Prepares with the support of the medical writing department the summary of clinical efficacy and clinical overview of the Common Technical Document (CTD). Provide input and reviews all clinical sections of the CTD (clinical pharmacology, summary of clinical safety…) and other sections whenever appropriate

  • Prepares answers to questions from Regulatory Agencies on the clinical efficacy of the project and collaborates with GPE in preparing answers on the clinical safety of the project, collaborates on other sections whenever appropriate

  • In charge of the medical/clinical assessment of license-in opportunities

The Clinical Research Director provides support

  • Reviews the Statistical Analysis Plans

  • For study protocols and Clinical Trial Authorization dossier, reviews* medical answers to clinical questions from Health Authorities and IRB/Ethics Committees

  • When appropriate collaborates with the CSD in preparing material for investigators meetings and in answering questions from investigators

  • Reviews the list of countries for clinical studies

  • Reviews* Key Results Memos and Clinical Study Reports

  • Provide clinical input to and reviews the Risk Management Plan

  • Reviews scientific publications and communications on the project

  • Prepares and provides key medical information on the project to internal people (e.g. market access, marketing, medical department in the affiliates…) and external people (e.g. Key Opinion Leaders) in respect with communication policies

Basic Qualifications

  • Medical Doctor or Doctor of Osteopathy preferred. If a MD, preferred to be board certified or eligible in Neurology

  • 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 experience within the field of neurology compounds.

Other Qualifications

  • Fluent in English (verbal and written communication)

  • Strong scientific and academic background with deep understanding of the disease

  • Clinical research or pharmaceutical experience medicine experience in neurology preferred

  • Knowledge of drug development preferred

  • Good networking ability in cross-cultural environment

  • Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization

  • 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

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At 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.

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