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Senior Clinical Research Director, Neurology, Ophthalmology and Gene Therapy Development

Cambridge, Massachusetts, Chilly-Mazarin, France

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Overview

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

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

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    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

POSITION OVERVIEW:

The Senior Clinical Research Director (Sr CRD) is the primary clinical lead for programs and responsible for leading successful clinical trials for novel therapeutics for Ophthalmologic Diseases.  The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks. The Sr CRD will work closely with researchers in the Sanofi Genomic Medicine Unit to bring two early ophthalmology projects into development.

The Neurology, Ophthalmology and Gene Therapy Development unit is a project-based organization. CRDs typically report to the Global Project Head and lead the cross-functional Global Clinical Team to establish the development strategy and execute the development plan.  We are looking for individuals with curiosity, scientific mindset, and appreciation of teamwork with a diverse group of internal and external experts.

MAIN RESPONSIBILITIES:

Some of the Clinical Research Director’s (CRD) 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 ophthalmology

  • 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

Key responsibilities:

  • Designs the global clinical development strategy and generates the Clinical Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy according to the project progression and information available

  • Leads the clinical development including planned life cycle management (LCM)

  • Ongoing assessment of the product benefit–risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team

  • Implements strategies to identify, monitor and resolve clinical program/trial issues.

  • Serves as the Study Director and Medical Monitor for a study or clinical program as well as reviewing and monitoring study data.

  • Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/communications for the study team and other stakeholders

  • Prepares/reviews key clinical documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD).

  • Provides clinical input to Statistical Analysis Plans, Target Product Profile and Risk Management Plan

  • Writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees and investigators

  • Reviews Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the project

  • Lead the medical/clinical assessment of license-in opportunities, as needed

  • Manage other CRDs and clinical scientists in the same program, as needed

The CRD is representative for Clinical Development:

  • at the Global Project Team

  • in meetings with Regulatory Agencies

  • in Steering Committees (SC) and Data Monitoring Committees (DMC)

  • 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)

BASIC QUALIFICATIONS:

  • Medical Doctor (MD) highly preferred, ophthalmology specialist

  • More than 5 years of clinical or scientific experience, or more than 10 years industry experience within the field of ophthalmology and retinal diseases

  • Fluent in English (verbal and written)

PREFERRED QUALIFICATIONS:

  • Board certified or eligible in Ophthalmology

  • Completion of a fellowship program in one of the following subspecialties: medical retina/uveitis, vitreoretinal surgery, neuro-ophthalmology

  • Strong scientific and academic background with deep understanding of retina and eye disease

  • Clinical research or pharmaceutical experience in ophthalmology

  • Knowledge of drug development

  • 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

Will consider remote (EST) for the right candidate

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 

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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