Clinical Study Director
Bridgewater, New Jersey,
This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
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JOB SUMMARY :
The role of the Clinical Study Director (CSD) is to provide medical expertise for:
- 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).
- Other clinical development activities (e.g. protocol optimization, 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).
- The CSD will 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.
- The CSD will be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data.
- He/she will have to interact with Strategic Units/Divisions/Franchise, Regulatory, Pharmacovigilance (CME, GSO), Project Leaders from CSO, feasibility managers, 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.
- The CSD may act as a Dedicated Project Expert (DPE) in Medical Operations, and may mentor other CSDs and CS on a same project TA.
MAJOR DUTIES AND 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, CSICF, TDF, study plans (eg: study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigators Meetings). Contribute to/review abbreviated protocol, publications, and communications of results.
- Collaborate and communicate appropriately with all stakeholders for optimal study
- 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
- Regulatory affairs
- Execution, including but not limited to:
- Review abbreviated protocol based on feasibility, protocol complexity index, associated cost, and even strategy, if appropriate.
- Responsible and accountable for overall supervision/execution of medical validation/review of study data, including writing or supervision of study related documents (eg: centralized monitoring plan, guidelines, etc…).
- Is key player to organize/contribute and/or participate in Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (eg charter, presentations).
- Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team.
- Secure CSD trial master file documents readiness and availability, and mandatory trainings linked to the function.
- Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc).
- Key role with Medical Writer to develop, review and finalize study protocols and reports.
- Maintain medical expertise in the therapeutic domain.
- Participates in transversal taskforces, working groups, best practice initiatives and project or therapeutic area meetings, as required.
- The CSD may include the role of DPE (depending on experience), where he/she is the key medical reference for the compound in Medical Operations, ensures uniform, aligned operational approach (eg harmonizing study documents, abbreviated protocols, protocols, etc), as relevant, within a project, ensures leadership, builds consensus, coordinates action plans with other CSDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to CSO and Division/Unit partners, as relevant and shares relevant information within Medical Operations (eg CSDs, Clinical Scientists).
- The DPE-CSD may have a mentoring and/or supervising role of more junior CSDs and Clinical Scientists supporting the studies within the same project or in the same therapeutic area/indication that he/she is in charge of.
- Good relationship with partners/units for developing trust and effectiveness.
Integration and collaboration with CTT members and CSUs (especially Medical Advisors).
- Demonstrated leadership.
- Establish and maintain a good relationship with Key Opinion Leaders and Investigators.
- Medical representatives in Units for the Units studies, in Divisions for the Divisions studies, medico-marketing representatives for the Medical Affairs studies, other customers. Feasibility managers, coding specialists; CTOMs, biostatisticians and other CTT members; CSUs Medical Advisors; GPE: Case Medical Evaluators, Global Safety Officers; CSO Project Leaders.
- Decision making authority on Feasibility, medical issues, recruitment strategy, retention plan, study risk management.
- Negotiations of medical matters with Investigators, Experts, internal units/customers and CROs.
- M.D. degree (or equivalent) required
- Minimum of 3 years in pharmaceutical industry or CRO with previous experience in clinical development OR minimum of 3 years of academic experience as investigator
- English fluent (spoken and written)
- Active U.S. Medical license, OR ECFMG certification preferred.
- Ideal candidate has a specialization in Dermatology, Pulmonology, or Rheumatology.
- Strong Scientific and medical expertise
- Experience in project management is preferred.
- Experience in clinical development and methodology of clinical studies
- Demonstrated 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
- Ability to make 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.
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.
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