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Senior Clinical Research Director, I&I (GI)

Sanofi

Sanofi

Cambridge, MA, USA · Multiple locations
Posted on Saturday, January 13, 2024

Senior Clinical Research Director, I&I (GI)

Cambridge, Massachusetts, Frankfurt am Main, Germany

Overview

From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.

Success Profile

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

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

Culture: Play to Win

  • Growth

  • Innovation

  • Efficiency

  • 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.

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

Senior Clinical Research Director, Early Development

The Senior Clinical Research Director (Sr CRD) supports several early stage programs and manages a team of Clinical Research Directors and Clinical scientists in Early Development I&I. The Sr CRD reports into the Head of Early Clinical Development I&I.

The role requires a well-organized, experienced, strategic focused and resourceful individual with managerial and interpersonal skills, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks.

The role of the Senior CRD is to:

  • Manage, coach and lead a team of Clinical Research Directors and Clinical scientists in the Early Development Team
  • Develop strategies and clinical development plans for one or more early programs and support their implementation
  • Support resources planning across the entire team
  • Collaborate with functions to ensure an uniform, aligned operational approach. Within a project, ensure leadership, build consensus, coordinate action plans with the respective GPH and other CRDs and stakeholders to resolve project-related study issues and anticipate potential issues
  • Lead clinical activities:
    • Provide clinical expertise
    • Support study related clinical activities, interaction with Health Authorities, provide medical input and support for all activities related to clinical studies
    • Support BD activities as needed

Team management in close collaboration with Head of Early Development

  • Supervise and manage Clinical Research Directors and Clinical Scientists to ensure appropriate support of projects within the pipeline
  • Train and coach Clinical Research Directors and Clinical Scientists on all aspects of clinical development, implementation, and execution of clinical studies
  • Assure adequate resourcing across projects
  • Translate mechanism-of-actions into a clinical strategy by validating indications and development of a competitive clinical plan
  • Support governance meetings through preparation of documents and presentations as needed
  • Engage and collaborate with internal and external partners, regulators, and experts
  • Develop protocols and execute phase 2 studies
  • 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)
  • Publish and present study results and other data

Experience

  • Clinical development in the field of immune driven diseases
  • Understanding of pharmaceutical product development and life cycle management gained through ~5 years of development and medical experience
  • Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
  • Strategic leadership and understanding of the drug development value chain
  • Excellent teaching skills, demonstrated ability to assist and train others
  • Ability to work within a matrix model
  • International/ intercultural working skills
  • Open-minded to apply new digital solutions

Minimum Level of any Required Qualifications:

  • Medical Doctor (MD): Gastroenterologist and/or experience in internal medicine and immune driven diseases
  • Fluency in written and spoken English

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.

#GD-SA

#LI-SA

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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