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.