Sanofi
Clinical Research Director
Sanofi, Cambridge, Massachusetts, us, 02140
Clinical Research DirectorApply locations Cambridge, MA time type Full time posted on Posted 3 Days Ago job requisition id R2758556
The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area, for the integrated evidence generation plan (IEPG) is responsible for the strategy, development, execution and reporting of key data generation activities (e.g., phase 3b interventional studies) of the IEGP to support successful development and launch of Amlitelimab (anti-OX40L) in atopic dermatitis.
The role will report to the atopic dermatitis Clinical Lead.
In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participate to the review process for protocols, study reports, and contributes/supports interactions with regulatory agencies and ethics committees.
Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.
Scientific and technical expertise
Has and maintains deep scientific, technical and clinical expertise in dermatology/immunology field
Has a demonstrated track record in clinical development, with Phase 3b and Phase 4 experience being an advantage
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
Maintains visibility within the dermatology field to maintain credibility with internal and external stakeholders
Contributes to gap identification and prioritization process for evidence generation plans
Contributes to the development of the integrated evidence generation plan
Collaborates with other functions e.g. Real World Evidence (RWE), Health Economics Outcomes Research (HEVA), market access, and commercial teams to ensure studies are fit for purpose and strategically aligned
Leads the development of the Abbreviated Protocol and Protocol development
Basic Qualifications
Medical Doctor with dermatology clinical expertise preferred
At least 2 years’ experience in pharmaceutical drug development or clinical research
Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
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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The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area, for the integrated evidence generation plan (IEPG) is responsible for the strategy, development, execution and reporting of key data generation activities (e.g., phase 3b interventional studies) of the IEGP to support successful development and launch of Amlitelimab (anti-OX40L) in atopic dermatitis.
The role will report to the atopic dermatitis Clinical Lead.
In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participate to the review process for protocols, study reports, and contributes/supports interactions with regulatory agencies and ethics committees.
Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.
Scientific and technical expertise
Has and maintains deep scientific, technical and clinical expertise in dermatology/immunology field
Has a demonstrated track record in clinical development, with Phase 3b and Phase 4 experience being an advantage
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
Maintains visibility within the dermatology field to maintain credibility with internal and external stakeholders
Contributes to gap identification and prioritization process for evidence generation plans
Contributes to the development of the integrated evidence generation plan
Collaborates with other functions e.g. Real World Evidence (RWE), Health Economics Outcomes Research (HEVA), market access, and commercial teams to ensure studies are fit for purpose and strategically aligned
Leads the development of the Abbreviated Protocol and Protocol development
Basic Qualifications
Medical Doctor with dermatology clinical expertise preferred
At least 2 years’ experience in pharmaceutical drug development or clinical research
Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
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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