Sanofi Group Clinical Study Director in Bridgewater, New Jersey
Provide medical expertise for the the clinical studies (except Clinical & Exploratory Pharmacology studies) and/or registries to be carried out by Clinical Sciences & Operations (eg: protocol, Key Results Memo, Clinical Study Report…).
Provide medical expertise for clinical development activities (e.g. pre-assessment and cluster feasibility, medical review and validation of clinical data, study risk assessment).
Contribute to the clinical part of Common Technical Document for FDA & EMA submission, answers to questions from health authorities for submission dossier).
Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
Act as the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data.
Interact with Strategic Units/Divisions/Franchise, Regulatory, Pharmaco-vigilance (CME, GSO), Project Leaders from CSO, Global Feasibility Leads (GFLs), CTOMs, biostatisticians, Clinical Documentation (Medical Writers), Monitoring team, Coding team, and for the studies from the Medical Affairs (global or regional) with Medico-marketing representatives from the appropriate departments.
Clinical study director may act as a Dedicated Project Expert (DPE) in OMD & CD, and may mentor other CSDs and CS on a same project TA.
Licensed Medical Doctor: GP or specialist, English fluent (spoken and written)
3+ years in pharmaceutical industry or CRO, previous experience in clinical development is preferred, OR 3+ years of academic experience as investigator
Additional Knowledge And Skills:
Strong Scientific and medical expertise
Experience in clinical development and methodology of clinical studies
Quality focused and well organized
Strong communication skills (verbal and written)
Ability to handle multiple tasks and to prioritize
Ability to synthesize the information, good presentation skills
Ability to take decisions
Capability to challenge decision and status quo
Ability to negotiate
Ability to work autonomously and to efficiently & effectively provide status reports
Ability to develop an holistic approach as regard to study conduct
Ability to anticipate and timely escalate issues and to define appropriate action plans
Team and results oriented
Teaching skills, ability to assist and train others
Ability to work within a matrix model
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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