Sanofi Group Clinical Study Director in Cambridge, Massachusetts
The role of the Clinical Study Director (CSD) is to provide medical expertise for:
The clinical 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. 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.
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 (Case Quality Officer, Global Safety Officer), Project Leaders from CSO, Global Feasibility Leads (GFLs), Clinical Trial Operations Managers, 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 acts as a Dedicated Project Expert (DPE) in OMD&CD on programs requiring this type of role. In addition, the CSD acts as a mentor for other CSDs and Clinical Scientists on a same project.
PRINCIPAL 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:
• GFLs 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
Challenge appropriately the study extended synopsis based on feasibility pre-assessment, protocol complexity index and associated cost.
Provide strategic & operational expertise to unit/department clinical sub team, as needed.
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 to Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (eg charter, presentations).
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.
As a DPE, he/she is the key medical reference for the compound in OMD&CD, ensures uniform, aligned operational approach (eg 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 OMD&CD (eg CSDs, Clinical Scientists) and beyond (project teams, etc.).
The DPE-CSD has 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, and in particular the strategic aspects of the IDP, relevant pre-clinical, compound, scientific, medical/indication-specific issues, specific safety-related issues (e.g. drug-class, compound, DDI, study population), the medico-marketing environment, the strategic medico-marketing plan, and key regulatory challenges.
The CSD (or DPE) participates in transversal taskforces, working groups, best practice initiatives and project or therapeutic area meetings, as required.
The CSD (or DPE) provides Uniform dissemination of relevant project-related information coming from the unit/department clinical sub team to the CSDs, clinical scientists and other relevant CSO-based study team members that conduct the project-related phase 2/3/4 clinical research studies for unit/department based clinical development programs.
LOCATION: This position can be based in either Bridgewater, NJ or Cambridge, MA.
Licensed Medical Doctor: GP or specialist
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)
Strong Scientific and medical expertise
Strong expertise in clinical development and methodology of clinical studies
Demonstrated strong leadership, foster team motivation, ability to influence and drive decisions
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
Strong decision maker
Demonstrated capability to challenge decision and status quo with a risk-management approach
Ability to negotiate
Ability to work autonomously and to efficiently & effectively provide status reports
Demonstrated ability to develop an holistic approach as regard to study and program conduct, identify synergies, coordinate a group of CSDs and organize delegation
Ability to anticipate and timely escalate issues and to define appropriate action plans
Team and results oriented
Teaching skills, demonstrated ability to assist and train others
Ability to work within a matrix model
Project management experience
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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