Senior Clinical Research Director, I&I (GI)

Sanofi

  • Cambridge, MA
  • Permanent
  • Full-time
  • 13 days ago
Senior Clinical Research Director, Early DevelopmentThe 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-SAPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !

Sanofi