Sanofi
Senior Clinical Research Director, Rare
Location:
Cambridge, MA or Morristown, NJ
Base pay range $225,000.00/yr - $375,000.00/yr
About the role Join the engine of Sanofi’s mission where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. As the
Senior Clinical Research Director
(Senior CRD) within the RARE Therapeutic Area, you will be the expert clinical lead for one or several indications in the Development of an R&D program. The role requires medical leadership, organization skills, and a strategically and operationally focused, resourceful individual. The Senior CRD shows capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self‑motivation, solid analytical skills, and the ability to deliver multiple operational tasks.
Key Responsibilities
Provide medical expertise to study teams to conduct clinical studies from early phases to LCM programs.
Collaborate with other medical and clinical scientific experts (CRDs or DSDs) under the leadership of the Global Project Head, Global Safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory body interactions.
Develop study‑level regulatory documentation (Abbreviated Protocol, Protocol, Amended Protocol) for projects and lead other operational development activities pertaining to study start‑up (e.g., press tests, competitive intelligence, patient engagement, study risk assessment).
medical input for all activities related to clinical study conduct such as answering IRB and HA questions, protocol training, medical review of data within Centralized monitoring, clinical and medical information for the study team, investigators, and clinical project leaders.
Prepare briefing regulatory documents, Common Technical Document (CTD) for submission to regulatory bodies (FDA, EMA, PMDA, etc.) and answer questions from health authorities.
Serve as the medical reference in the clinical study team, ensuring data relevance and mentoring other DMDs/DSDs/CSs, and transmit medical/scientific strategy by indication.
Lead the clinical development plan strategies including clinical sections of integrated development plans (IDP), contribute to product value proposition, target product profile, and market access strategy.
Collaborate with internal and external stakeholders, resolve project‑related issues, and propose corrective action plans.
Provide operational expertise to project clinical sub‑team, develop protocols, informed consent forms, study committees, and key clinical questions.
Represent the project in interactions with regulatory bodies, write clinical sections of CTD and support registration and labeling.
Participate in advisory committee preparation and scientific data evaluation and authorship, including manuscript and abstract preparation.
Experience & Qualifications
At least 4 years of clinical development experience in the pharmaceutical industry, CRO, or clinical development in a healthcare institution.
MD preferred; GP or specialist with training in pediatrics or pediatric neurology is a plus.
Strong medical and scientific expertise in clinical development and methodology of clinical studies.
Excellent problem‑solving capability and ability to challenge decision and status quo with a risk‑management approach.
Quality‑focused, adept at developing good practices using a data‑driven approach.
Experience in interacting with Health Authorities and preparing regulatory documents.
Excellent communication skills (verbal and written) for cross‑functional interaction and regulatory engagement.
Demonstrated ability to mentor and evaluate resources and manage multiple tasks with prioritization.
International/intercultural working skills and openness to applying new digital solutions.
Key Soft Skills
Communication, problem‑solving, decision challenge, quality focus, prioritization, negotiation, mentoring, matrix management, intercultural skills.
Key Technical Skills
Pharmaceutical product development lifecycle.
Clinical development and methodology expertise.
Regulatory interactions and document preparation.
Education Medical Doctor (MD) preferred, with training in pediatrics or pediatric neurology.
Languages English fluent (spoken and written).
Benefits
Supportive, future‑focused team and opportunities for growth locally and internationally.
Well‑crafted rewards package that recognizes contribution.
Health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave.
Equal Opportunity Employer Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff irmative 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, marital or domestic partnership status, sex, gender, sexual orientation, disability, veteran, domestic violence victim status, or any other characteristic protected by law.
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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Cambridge, MA or Morristown, NJ
Base pay range $225,000.00/yr - $375,000.00/yr
About the role Join the engine of Sanofi’s mission where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. As the
Senior Clinical Research Director
(Senior CRD) within the RARE Therapeutic Area, you will be the expert clinical lead for one or several indications in the Development of an R&D program. The role requires medical leadership, organization skills, and a strategically and operationally focused, resourceful individual. The Senior CRD shows capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self‑motivation, solid analytical skills, and the ability to deliver multiple operational tasks.
Key Responsibilities
Provide medical expertise to study teams to conduct clinical studies from early phases to LCM programs.
Collaborate with other medical and clinical scientific experts (CRDs or DSDs) under the leadership of the Global Project Head, Global Safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory body interactions.
Develop study‑level regulatory documentation (Abbreviated Protocol, Protocol, Amended Protocol) for projects and lead other operational development activities pertaining to study start‑up (e.g., press tests, competitive intelligence, patient engagement, study risk assessment).
medical input for all activities related to clinical study conduct such as answering IRB and HA questions, protocol training, medical review of data within Centralized monitoring, clinical and medical information for the study team, investigators, and clinical project leaders.
Prepare briefing regulatory documents, Common Technical Document (CTD) for submission to regulatory bodies (FDA, EMA, PMDA, etc.) and answer questions from health authorities.
Serve as the medical reference in the clinical study team, ensuring data relevance and mentoring other DMDs/DSDs/CSs, and transmit medical/scientific strategy by indication.
Lead the clinical development plan strategies including clinical sections of integrated development plans (IDP), contribute to product value proposition, target product profile, and market access strategy.
Collaborate with internal and external stakeholders, resolve project‑related issues, and propose corrective action plans.
Provide operational expertise to project clinical sub‑team, develop protocols, informed consent forms, study committees, and key clinical questions.
Represent the project in interactions with regulatory bodies, write clinical sections of CTD and support registration and labeling.
Participate in advisory committee preparation and scientific data evaluation and authorship, including manuscript and abstract preparation.
Experience & Qualifications
At least 4 years of clinical development experience in the pharmaceutical industry, CRO, or clinical development in a healthcare institution.
MD preferred; GP or specialist with training in pediatrics or pediatric neurology is a plus.
Strong medical and scientific expertise in clinical development and methodology of clinical studies.
Excellent problem‑solving capability and ability to challenge decision and status quo with a risk‑management approach.
Quality‑focused, adept at developing good practices using a data‑driven approach.
Experience in interacting with Health Authorities and preparing regulatory documents.
Excellent communication skills (verbal and written) for cross‑functional interaction and regulatory engagement.
Demonstrated ability to mentor and evaluate resources and manage multiple tasks with prioritization.
International/intercultural working skills and openness to applying new digital solutions.
Key Soft Skills
Communication, problem‑solving, decision challenge, quality focus, prioritization, negotiation, mentoring, matrix management, intercultural skills.
Key Technical Skills
Pharmaceutical product development lifecycle.
Clinical development and methodology expertise.
Regulatory interactions and document preparation.
Education Medical Doctor (MD) preferred, with training in pediatrics or pediatric neurology.
Languages English fluent (spoken and written).
Benefits
Supportive, future‑focused team and opportunities for growth locally and internationally.
Well‑crafted rewards package that recognizes contribution.
Health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave.
Equal Opportunity Employer Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff irmative 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, marital or domestic partnership status, sex, gender, sexual orientation, disability, veteran, domestic violence victim status, or any other characteristic protected by law.
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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