Clinical Research Director, I&I
Sanofi
6 months ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Clinical Research Director (CRD)
Location: Cambridge, MA / Morristown, NJ
Main Responsibilities
- Provide medical expertise to the Study team to conduct clinical studies from early phases through LCM programs.
- Collaborate with medical/clinical scientific experts (under the Global Project Head) and partners including Global Safety, Regulatory Strategist, and other functions to deliver development strategy and support regulatory interactions.
- Develop study-level regulatory documentation (Abbreviated Protocol, Protocol, Protocol Amendments) and lead study start-up activities (e.g., pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment).
- Provide medical input/support for clinical conduct activities (IRB/health authority responses, protocol training, medical review of data within centralized monitoring scope, study team medical information, support for medical advisors/Clinical Project Leaders and investigators).
- Contribute to the clinical portion of the Common Technical Document (CTD) 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 strategy and clinical sections of integrated development plans (IDP).
- Collaborate with other CRDs/DSDs; coordinate actions with stakeholders to resolve issues, anticipate risks, and share lessons learned.
- Raise study/project-level issues and propose corrective action plans.
- Contribute to TVP/TPP/market access strategy and research focus by providing input on clinical needs and approaches.
- Evaluate relevant medical literature and competitive products.
Execution of Clinical Development/Studies
- Partner with cross-functional stakeholders to ensure GCP-compliant trial execution (timelines, budgets, contingency/risk management).
- Develop the abbreviated protocol, final protocol, and protocol amendments.
- Develop/review the Core Study Informed Consent Form (CSICF); develop/review study committee charters.
- Support feasibility and competitive intelligence with the Global feasibility manager.
- Review/provide clinical input to study documents (e.g., Vendor RFPs, e-CRF, eCOA, study plans, risk management plan, monitoring/centralized monitoring plans).
- Support training materials and investigator/local team trainings; answer HA/EC/IRB/site medical questions.
- Ensure clinical data quality via continuous data validation and blinded data review (safety/efficacy surveillance).
- Ensure trial master file readiness and availability and mandatory clinical-function trainings.
- Lead study-specific committees (IDMC, steering committee, adjudication) with operational support.
- Co-develop the SAP with biostatistics; prepare key results; develop/review the clinical study report.
Regulatory & Safety Documents/Meetings
- Review and/or contribute to the 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; partner with Patient Safety GSO to detect/document safety signals.
- Participate in Advisory Committee preparation.
Scientific Data Evaluation & Authorship
- Participate and author manuscripts and abstracts.
- Build/manage collaborations with knowledge experts/advisory boards.
- Support ad hoc tasks (e.g., evaluation of potential in-licensing candidates) and serve as a clinical advisor to research teams.
Qualifications & Requirements
- MD or equivalent patient care-related medical degree (DO, international equivalents, etc.) required.
- At least 3 years of prior clinical development experience in pharmaceutical industry or a CRO, or medical experience in clinical development in a healthcare institution.
Preferred Qualifications
- Background in respiratory, allergy, or immunology.
Skills
- Very strong verbal and written communication across functions and with regulatory agencies.
- Excellent problem-solving; ability to challenge decisions/status quo using risk-management.
- Negotiation skills to secure operational resources.
- Strong teaching/training ability.
- Ability to work in a matrix model; international/intercultural working skills.
- Open-mindedness to apply digital solutions.
Technical Skills
- Understanding of pharmaceutical product development and life cycle management.
- Strong scientific and medical/clinical expertise.
- Strong expertise in clinical development and clinical study methodology.
Education
- MD (Doctor of Medicine) or equivalent patient care-related medical degree required.
Languages
- English fluent (spoken and written).
Benefits (if explicitly stated)
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
Location: Cambridge, MA / Morristown, NJ
Main Responsibilities
- Provide medical expertise to the Study team to conduct clinical studies from early phases through LCM programs.
- Collaborate with medical/clinical scientific experts (under the Global Project Head) and partners including Global Safety, Regulatory Strategist, and other functions to deliver development strategy and support regulatory interactions.
- Develop study-level regulatory documentation (Abbreviated Protocol, Protocol, Protocol Amendments) and lead study start-up activities (e.g., pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment).
- Provide medical input/support for clinical conduct activities (IRB/health authority responses, protocol training, medical review of data within centralized monitoring scope, study team medical information, support for medical advisors/Clinical Project Leaders and investigators).
- Contribute to the clinical portion of the Common Technical Document (CTD) 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 strategy and clinical sections of integrated development plans (IDP).
- Collaborate with other CRDs/DSDs; coordinate actions with stakeholders to resolve issues, anticipate risks, and share lessons learned.
- Raise study/project-level issues and propose corrective action plans.
- Contribute to TVP/TPP/market access strategy and research focus by providing input on clinical needs and approaches.
- Evaluate relevant medical literature and competitive products.
Execution of Clinical Development/Studies
- Partner with cross-functional stakeholders to ensure GCP-compliant trial execution (timelines, budgets, contingency/risk management).
- Develop the abbreviated protocol, final protocol, and protocol amendments.
- Develop/review the Core Study Informed Consent Form (CSICF); develop/review study committee charters.
- Support feasibility and competitive intelligence with the Global feasibility manager.
- Review/provide clinical input to study documents (e.g., Vendor RFPs, e-CRF, eCOA, study plans, risk management plan, monitoring/centralized monitoring plans).
- Support training materials and investigator/local team trainings; answer HA/EC/IRB/site medical questions.
- Ensure clinical data quality via continuous data validation and blinded data review (safety/efficacy surveillance).
- Ensure trial master file readiness and availability and mandatory clinical-function trainings.
- Lead study-specific committees (IDMC, steering committee, adjudication) with operational support.
- Co-develop the SAP with biostatistics; prepare key results; develop/review the clinical study report.
Regulatory & Safety Documents/Meetings
- Review and/or contribute to the 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; partner with Patient Safety GSO to detect/document safety signals.
- Participate in Advisory Committee preparation.
Scientific Data Evaluation & Authorship
- Participate and author manuscripts and abstracts.
- Build/manage collaborations with knowledge experts/advisory boards.
- Support ad hoc tasks (e.g., evaluation of potential in-licensing candidates) and serve as a clinical advisor to research teams.
Qualifications & Requirements
- MD or equivalent patient care-related medical degree (DO, international equivalents, etc.) required.
- At least 3 years of prior clinical development experience in pharmaceutical industry or a CRO, or medical experience in clinical development in a healthcare institution.
Preferred Qualifications
- Background in respiratory, allergy, or immunology.
Skills
- Very strong verbal and written communication across functions and with regulatory agencies.
- Excellent problem-solving; ability to challenge decisions/status quo using risk-management.
- Negotiation skills to secure operational resources.
- Strong teaching/training ability.
- Ability to work in a matrix model; international/intercultural working skills.
- Open-mindedness to apply digital solutions.
Technical Skills
- Understanding of pharmaceutical product development and life cycle management.
- Strong scientific and medical/clinical expertise.
- Strong expertise in clinical development and clinical study methodology.
Education
- MD (Doctor of Medicine) or equivalent patient care-related medical degree required.
Languages
- English fluent (spoken and written).
Benefits (if explicitly stated)
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.