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Senior Clinical Research Director, I&I (GI)
剑桥, 麻薩諸塞州 Permanent 发布日期 01/05/2024Senior Clinical Research Director, Early Development
About the Job
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
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
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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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体验可能性
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