Sanofi
Clinical Research Director, I&I
Sanofi, Bridgewater, Massachusetts, us, 02324
Clinical Research Director, I&I
About the JobWe are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area will be responsible for creation and execution of clinical development plans for lunsekimig, a key asset in the I&I pipeline that is advancing across multiple indications. Important responsibilities will include supporting governance evaluation of development strategy in collaboration with the lunsekimig project team, as well as study execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in respiratory, allergy, or immunology, incorporating innovation and new methodologies, and pro-actively progressing study execution.MAIN RESPONSABILITIESCreate the clinical development strategy for one or more assets in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.Advance the CDP through internal management review.Lead a clinical sub team to design clinical studies, create an abbreviated and full clinical study protocol.Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations.Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation).Contribute to data review, interpretation and publication of clinical study results.Be experienced in advancing assets from discovery into clinical development.Have experience in novel approaches in translational medicine.Have and maintain deep scientific, technical and clinical knowledge in pulmonary, allergy, dermatology or immunology, or demonstrate strong experience in drug development.Demonstrated problem-solving skills.Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area.Basic QualificationsMedical Doctor. Should be board certified or equivalent in pulmonary medicine, dermatology or allergy/immunology, or other specialty with a strong development background.Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent.More than 5 years of clinical or scientific and/or more than 10 years industry experience within the field of dermatology.Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred.Knowledge of drug development preferred.Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment.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.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.
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About the JobWe are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area will be responsible for creation and execution of clinical development plans for lunsekimig, a key asset in the I&I pipeline that is advancing across multiple indications. Important responsibilities will include supporting governance evaluation of development strategy in collaboration with the lunsekimig project team, as well as study execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in respiratory, allergy, or immunology, incorporating innovation and new methodologies, and pro-actively progressing study execution.MAIN RESPONSABILITIESCreate the clinical development strategy for one or more assets in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.Advance the CDP through internal management review.Lead a clinical sub team to design clinical studies, create an abbreviated and full clinical study protocol.Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations.Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation).Contribute to data review, interpretation and publication of clinical study results.Be experienced in advancing assets from discovery into clinical development.Have experience in novel approaches in translational medicine.Have and maintain deep scientific, technical and clinical knowledge in pulmonary, allergy, dermatology or immunology, or demonstrate strong experience in drug development.Demonstrated problem-solving skills.Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area.Basic QualificationsMedical Doctor. Should be board certified or equivalent in pulmonary medicine, dermatology or allergy/immunology, or other specialty with a strong development background.Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent.More than 5 years of clinical or scientific and/or more than 10 years industry experience within the field of dermatology.Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred.Knowledge of drug development preferred.Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment.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.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.
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