Clinical Research Director, I&I
Sanofi
6 months ago
Remote friendly (Morristown, NJ)
United States
Clinical Research and Development
Clinical Research Director (CRD)
Main Responsibilities
- Provide medical expertise to the Study team to conduct clinical studies from early phases to LCM programs.
- Collaborate with medical/clinical scientific experts (under Global Project Head leadership) plus Global Safety Officer, Regulatory Strategist and other functions to deliver development strategy and support regulatory interactions.
- Develop study-level regulatory documentation (Abbreviated Protocol, Protocol, Amended Protocol) and lead study-startup activities (e.g., pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment).
- Provide medical input and support for clinical-study conduct (IRB and health authority questions, protocol scientific/medical training, medical review of data within centralized monitoring scope, medical/clinical information for study teams, support to medical advisors/Clinical Project Leaders and investigators).
- Contribute the clinical portion of the Common Technical Document (e.g., FDA/EMA/PMDA) and answer questions from health authorities.
- Serve as the medical reference for the Clinical Study team, ensuring medical relevance of clinical data.
Key Responsibilities
- Own clinical development plan strategies and clinical sections of integrated development plans (IDP).
- Coordinate with other CRDs/DSDs to build consensus, resolve issues, anticipate risks, and share lessons learned.
- Raise study/project-level issues to the project head and propose corrective action plans.
- Provide input to TVP/TPP, market access strategy, and research strategy (based on clinical needs and clinical development approaches).
- Evaluate medical literature and competitive product status.
Execution & Study Oversight
- Collaborate with functional stakeholders to ensure successful trial execution in compliance with GCP, laws/regulations, and SOPs (timelines, budgets, contingency/risk management).
- Develop abbreviated/final protocols and protocol amendments.
- Develop/review Core Study Informed Consent Form (CSICF) and study committee charters.
- Support feasibility/competitive intelligence questions with the Global feasibility manager.
- Review and provide clinical input to study documents (e.g., vendor RFPs, e-CRF, eCOA).
- Provide input to study plans (e.g., study risk management plan; monitoring/centralized monitoring plans).
- Participate in training material and presentations for investigators/local teams.
- Answer medical questions from health authorities, EC/IRBs, and sites.
- Ensure clinical data quality via continuous data validation and blinded data review (safety/efficacy case review).
- Ensure trial master file readiness and linked mandatory trainings.
- Lead study-specific committees (IDMC, steering committee, adjudication, etc.) with operational support.
- Co-develop the SAP with biostatistics.
- Prepare key results and develop/review the clinical study report.
Regulatory & Safety Documents/Meetings
- Review and/or contribute to clinical sections of Investigator’s Brochure, CTA, IND, DSUR, DRMP, RMP.
- Write/review clinical sections of BLA/CTD, briefing packages for regulatory meetings, PSP/PIP.
- Ensure clinical data meets regulatory standards; collaborate with Patient Safety GSO to detect/document safety signals.
- Participate in Advisory Committee preparation.
Scientific Data Evaluation & Authorship
- Participate and author manuscripts and abstracts.
- Maintain collaborations with knowledge experts/advisory boards.
- Provide ad hoc input (e.g., evaluation of in-licensing candidates) and serve as clinical advisor to research teams.
Qualifications / Requirements
- MD (Doctor of Medicine) or equivalent patient care-related medical degree (DO, international equivalents, etc.) required.
- At least 3 years prior experience in clinical development in pharmaceutical industry or a CRO, or medical experience in clinical development in a healthcare institution.
- Background in respiratory, allergy, or immunology preferred.
Skills
- Strong verbal and written communication across functional areas and with key regulatory agencies.
- Excellent problem-solving; risk-management approach.
- Ability to negotiate operational resources for continued clinical conduct.
- Strong teaching/training skills.
- Ability to work in a matrix model; international/intercultural working skills.
- Open-minded to apply new digital solutions.
Technical Skills
- Understanding of pharmaceutical product development and life cycle management.
- Strong scientific and medical/clinical expertise.
- Strong clinical development expertise and methodology.
Education
- MD or equivalent patient care-related medical degree required.
Languages
- English fluent (spoken and written).
Main Responsibilities
- Provide medical expertise to the Study team to conduct clinical studies from early phases to LCM programs.
- Collaborate with medical/clinical scientific experts (under Global Project Head leadership) plus Global Safety Officer, Regulatory Strategist and other functions to deliver development strategy and support regulatory interactions.
- Develop study-level regulatory documentation (Abbreviated Protocol, Protocol, Amended Protocol) and lead study-startup activities (e.g., pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment).
- Provide medical input and support for clinical-study conduct (IRB and health authority questions, protocol scientific/medical training, medical review of data within centralized monitoring scope, medical/clinical information for study teams, support to medical advisors/Clinical Project Leaders and investigators).
- Contribute the clinical portion of the Common Technical Document (e.g., FDA/EMA/PMDA) and answer questions from health authorities.
- Serve as the medical reference for the Clinical Study team, ensuring medical relevance of clinical data.
Key Responsibilities
- Own clinical development plan strategies and clinical sections of integrated development plans (IDP).
- Coordinate with other CRDs/DSDs to build consensus, resolve issues, anticipate risks, and share lessons learned.
- Raise study/project-level issues to the project head and propose corrective action plans.
- Provide input to TVP/TPP, market access strategy, and research strategy (based on clinical needs and clinical development approaches).
- Evaluate medical literature and competitive product status.
Execution & Study Oversight
- Collaborate with functional stakeholders to ensure successful trial execution in compliance with GCP, laws/regulations, and SOPs (timelines, budgets, contingency/risk management).
- Develop abbreviated/final protocols and protocol amendments.
- Develop/review Core Study Informed Consent Form (CSICF) and study committee charters.
- Support feasibility/competitive intelligence questions with the Global feasibility manager.
- Review and provide clinical input to study documents (e.g., vendor RFPs, e-CRF, eCOA).
- Provide input to study plans (e.g., study risk management plan; monitoring/centralized monitoring plans).
- Participate in training material and presentations for investigators/local teams.
- Answer medical questions from health authorities, EC/IRBs, and sites.
- Ensure clinical data quality via continuous data validation and blinded data review (safety/efficacy case review).
- Ensure trial master file readiness and linked mandatory trainings.
- Lead study-specific committees (IDMC, steering committee, adjudication, etc.) with operational support.
- Co-develop the SAP with biostatistics.
- Prepare key results and develop/review the clinical study report.
Regulatory & Safety Documents/Meetings
- Review and/or contribute to clinical sections of Investigator’s Brochure, CTA, IND, DSUR, DRMP, RMP.
- Write/review clinical sections of BLA/CTD, briefing packages for regulatory meetings, PSP/PIP.
- Ensure clinical data meets regulatory standards; collaborate with Patient Safety GSO to detect/document safety signals.
- Participate in Advisory Committee preparation.
Scientific Data Evaluation & Authorship
- Participate and author manuscripts and abstracts.
- Maintain collaborations with knowledge experts/advisory boards.
- Provide ad hoc input (e.g., evaluation of in-licensing candidates) and serve as clinical advisor to research teams.
Qualifications / Requirements
- MD (Doctor of Medicine) or equivalent patient care-related medical degree (DO, international equivalents, etc.) required.
- At least 3 years prior experience in clinical development in pharmaceutical industry or a CRO, or medical experience in clinical development in a healthcare institution.
- Background in respiratory, allergy, or immunology preferred.
Skills
- Strong verbal and written communication across functional areas and with key regulatory agencies.
- Excellent problem-solving; risk-management approach.
- Ability to negotiate operational resources for continued clinical conduct.
- Strong teaching/training skills.
- Ability to work in a matrix model; international/intercultural working skills.
- Open-minded to apply new digital solutions.
Technical Skills
- Understanding of pharmaceutical product development and life cycle management.
- Strong scientific and medical/clinical expertise.
- Strong clinical development expertise and methodology.
Education
- MD or equivalent patient care-related medical degree required.
Languages
- English fluent (spoken and written).