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.

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