Sanofi
Clinical Lead, Early Clinical and Experimental Therapeutics
Sanofi, Convent Station, New Jersey, us, 07961
Clinical Lead, Early Clinical & Experimental Therapeutics
Location:
Cambridge, MA / Morristown, NJ
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our state‑of‑the‑art ECET department as a Clinical Lead and drive the translation between preclinical development through early clinical development and beyond, while enjoying numerous opportunities to broaden your experience and hone your skills.
Main Responsibilities
Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating into the overall development strategy in collaboration with the responsible Therapeutic Area in R&D.
Design safe, rapid and informative First‑In‑Human studies (including First In Patients, natural history, experimental model validation, mechanistic and signal‑seeking) and streamlined Proof‑of‑Mechanism/Proof‑of‑Concept studies to provide robust data for early go/no‑go decisions and other pharmacokinetic studies.
Supervise the execution of studies and ensure close medical monitoring.
Review, interpret results, and author ECET‑related clinical documentation, including informed consent forms, clinical protocols, study reports, abstracts/manuscripts, and clinical pharmacology or ECET components of investigator brochures and regulatory documents.
Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned areas and liaise with partners on projects.
Participate in dose selection for First‑In‑Human studies and drive go/no‑go decisions when needed.
Ensure adequate follow‑up of studies and project timelines.
Present data at appropriate meetings, both internally and externally.
Key Internal / External Relationships
Internal contacts: Other TMU departments (Pre‑Clinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations, Evidence Generation & Decision Science), Early Development Clinical Operations (clinical trial managers and data managers), Regulatory Affairs, Patient Safety & Pharmacovigilance, Therapeutic Area R&D groups.
External contacts: Investigators, clinical site services providers, early‑phase CROs, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives.
Study Preparation – Study Medical Manager (SMM)
Design and conduct early clinical development studies, including phase 2a, within planned timelines.
Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.).
Coordinate clinical team to set up and follow the study.
Ensure proper documentation is provided to Ethics Committees and Health Authorities.
Study Conduct
Ensure the study is scientifically sound and correctly conducted.
Prepare and review interim investigator reports.
Lead the dose‑escalation meeting and document decision making for First‑in‑Human studies.
Review adverse event reports.
Study Validation and Reporting
Participate in data review and validation meetings before database lock.
Review and interpret results.
Prepare and distribute the Key Results Memo and prepare/review the Clinical Study Report.
Major Challenges and Opportunities
Act as spokesperson for TMU and Clinical Patient Sciences, emphasizing the position’s strengths.
Engage actively in scientific challenges of early clinical development, demonstrating curiosity and proactivity.
Maintain clinical trial standards at the site and coordinate with other clinical functions.
Produce high‑quality documents, requiring strong writing and communication skills.
Manage aggressive timelines through cross‑functional planning.
Make front‑line decisions on protocol design, execution, dose escalation, safety, and regulatory information.
Experience Mandatory Qualifications
Solid experience in designing and executing early development clinical trials (phase 1a/b and 2a) and exploratory studies in the pharmaceutical industry and/or academic institutions, hospitals, clinical sites, or CROs.
Nice‑to‑Have Qualifications
Knowledge and mindset in translational research.
Experience conducting late‑phase clinical trials.
Education and Training Mandatory Qualifications
Advanced degree: M.D. or M.D./Ph.D. with at least 1–5 years of research experience.
Postgraduate residency training; laboratory research in industry or academia.
Broad biomedical knowledge base.
Knowledge and mindset in translational research.
Able to acquire and apply new technical skills.
Nice‑to‑Have Qualifications
M.D./Ph.D. strongly preferred.
Soft and Technical Skills
Very good verbal and written communication skills for interactions across functional areas and with regulatory agencies.
Demonstrated capability to challenge decisions and the status quo with a risk‑management approach.
Ability to work within a matrix organization across CPS, TMU, R&D, and medical domains.
International/intercultural working skills.
Open‑mindedness to apply new digital and/or AI‑driven solutions.
Languages Fluent in English.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future‑focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits, including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender‑neutral parental leave.
Equal Opportunity Employer 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, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information, or any other characteristic protected by law.
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Cambridge, MA / Morristown, NJ
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our state‑of‑the‑art ECET department as a Clinical Lead and drive the translation between preclinical development through early clinical development and beyond, while enjoying numerous opportunities to broaden your experience and hone your skills.
Main Responsibilities
Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating into the overall development strategy in collaboration with the responsible Therapeutic Area in R&D.
Design safe, rapid and informative First‑In‑Human studies (including First In Patients, natural history, experimental model validation, mechanistic and signal‑seeking) and streamlined Proof‑of‑Mechanism/Proof‑of‑Concept studies to provide robust data for early go/no‑go decisions and other pharmacokinetic studies.
Supervise the execution of studies and ensure close medical monitoring.
Review, interpret results, and author ECET‑related clinical documentation, including informed consent forms, clinical protocols, study reports, abstracts/manuscripts, and clinical pharmacology or ECET components of investigator brochures and regulatory documents.
Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned areas and liaise with partners on projects.
Participate in dose selection for First‑In‑Human studies and drive go/no‑go decisions when needed.
Ensure adequate follow‑up of studies and project timelines.
Present data at appropriate meetings, both internally and externally.
Key Internal / External Relationships
Internal contacts: Other TMU departments (Pre‑Clinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations, Evidence Generation & Decision Science), Early Development Clinical Operations (clinical trial managers and data managers), Regulatory Affairs, Patient Safety & Pharmacovigilance, Therapeutic Area R&D groups.
External contacts: Investigators, clinical site services providers, early‑phase CROs, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives.
Study Preparation – Study Medical Manager (SMM)
Design and conduct early clinical development studies, including phase 2a, within planned timelines.
Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.).
Coordinate clinical team to set up and follow the study.
Ensure proper documentation is provided to Ethics Committees and Health Authorities.
Study Conduct
Ensure the study is scientifically sound and correctly conducted.
Prepare and review interim investigator reports.
Lead the dose‑escalation meeting and document decision making for First‑in‑Human studies.
Review adverse event reports.
Study Validation and Reporting
Participate in data review and validation meetings before database lock.
Review and interpret results.
Prepare and distribute the Key Results Memo and prepare/review the Clinical Study Report.
Major Challenges and Opportunities
Act as spokesperson for TMU and Clinical Patient Sciences, emphasizing the position’s strengths.
Engage actively in scientific challenges of early clinical development, demonstrating curiosity and proactivity.
Maintain clinical trial standards at the site and coordinate with other clinical functions.
Produce high‑quality documents, requiring strong writing and communication skills.
Manage aggressive timelines through cross‑functional planning.
Make front‑line decisions on protocol design, execution, dose escalation, safety, and regulatory information.
Experience Mandatory Qualifications
Solid experience in designing and executing early development clinical trials (phase 1a/b and 2a) and exploratory studies in the pharmaceutical industry and/or academic institutions, hospitals, clinical sites, or CROs.
Nice‑to‑Have Qualifications
Knowledge and mindset in translational research.
Experience conducting late‑phase clinical trials.
Education and Training Mandatory Qualifications
Advanced degree: M.D. or M.D./Ph.D. with at least 1–5 years of research experience.
Postgraduate residency training; laboratory research in industry or academia.
Broad biomedical knowledge base.
Knowledge and mindset in translational research.
Able to acquire and apply new technical skills.
Nice‑to‑Have Qualifications
M.D./Ph.D. strongly preferred.
Soft and Technical Skills
Very good verbal and written communication skills for interactions across functional areas and with regulatory agencies.
Demonstrated capability to challenge decisions and the status quo with a risk‑management approach.
Ability to work within a matrix organization across CPS, TMU, R&D, and medical domains.
International/intercultural working skills.
Open‑mindedness to apply new digital and/or AI‑driven solutions.
Languages Fluent in English.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future‑focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits, including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender‑neutral parental leave.
Equal Opportunity Employer 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, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information, or any other characteristic protected by law.
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