Sanofi Group Clinical Study Director in Cambridge, Massachusetts

Responsibilities:

  • Provide expertise and act as a reference for all medical operational activities related to the projects/studies he/she is assigned to

  • Write/contribute/review/QC/validate study related documents: clinical protocols, written subject information, study reference manual, trial disclosure form, Case report form, study plans (eg: study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigators Meetings). Contribute to publications and communications of results. Potentially write ES in some specific cases (eg: Medical Affairs studies).

  • Collaborate and communicate appropriately with all stakeholders for optimal study execution, including but not limited to: feasibility managers for feasibility preparation and validation of feasibility results, Clinical Scientists, Medical review team and Coding; Pharmacovigilance (GSO, CME) as regard to safety management and case processing; CTOMs, Biostatisticians; CSU medical advisors for the best knowledge of the study, compound, protocol; Units/Divisions and medical affairs; CROs; Regulatory affairs

  • Challenge appropriately the study extended synopsis based on feasibility pre-assessment, protocol complexity index and associated cost

  • Responsible and accountable for overall supervision/execution of medical validation/review of study data, including writing or supervision of study related documents (eg: medical review plan, guidelines, etc.).

  • Key role in organization/contribution to Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and preparation of related material (eg. charter, presentations).

  • Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team.

  • Key role with Medical Writer to develop, review and finalize study protocols and reports.

  • Maintain medical expertise in the therapeutic domain.

  • Secure CSD trial master file documents readiness and availability, and mandatory trainings linked to the function

Required Education/Experience:

  • Licensed Medical Doctor: GP or specialist.

  • Minimum 3 years prior experience in pharmaceutical industry or CRO

  • Scientific and medical expertise.

  • Ability to demonstrate leadership.

  • 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.

  • Capability to challenge decision and status quo.

  • Ability to negotiate.

  • Ability to work autonomously and to efficiently & effectively provide status reports.

  • 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 in a matrix model.

Preferred experience

  • Previous experience in clinical development, or academic experience, preferably as Investigator

Sanofi US Services, 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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life