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 (e.g.: protocol, Key Results Memo, Clinical Study Report).
Other 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 and 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, written
subject information, 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
CSU medical advisors for the best knowledge of the study, compound, protocol
Units/Divisions and medical 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).
Is key role to organize/contribute and/or participate in Investigators' Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (e.g., 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 (e.g., 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.
The CSD participates in transversal taskforces, working groups, best practice initiatives and project or therapeutic area meetings, as required.
The CSD may endorse the role of DPE, where he/she is the key medical reference for the compound in Medical Operations, ensures uniform, aligned operational approach (e.g., harmonizing study documents, ES, 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 (e.g., 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).
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.
Cardiology experience is strongly preferred.
Strong Scientific and medical expertise
Experience in project management is preferred.
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 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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