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Clinical Research Director

Synthorx

Synthorx

Administration
Cambridge, MA, USA
Posted on Tuesday, August 6, 2024

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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