Senior Clinical Research Director

Job title: Senior Clinical Research Director

Location: Cambridge, MA

About the Job

About the job

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 Fitusiran Clinical Team as Senior Clinical Research Director and you will be the primary Clinical Lead for Phase 3 registrational studies and on-going NDA submissions. Qfitlia (fitusiran) is a first-in-class AT lowering therapy approved by the US FDA for prophylactic treatment of adults and pediatric patients

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

The Senior Clinical Research Director (Sr CRD), Hemophilia in Rare and Rare Blood Disorders Therapeutic Area,  is noted as a primary clinical lead for programs.

Main responsibilities:

· Develop and implement clinical development plan strategies.

· Lead, support, and oversee the execution of clinical development and study activities.

· Collaborate with functions to ensure a uniform, aligned operational approach. Provide leadership, build consensus, and coordinate action plans with other CRDs and stakeholders to resolve project-related clinical study issues.

· Contribute to the clinical part of submission dossiers for projects, including responsibilities related to regulatory and safety documents and meetings.

· Serve as the medical reference in the team, ensuring the medical relevance of clinical data.

· Lead scientific data evaluation and dissemination.

· Ensures strict compliance with current regulations, laws and HA guidance as well as with Sanofi’s policies and procedures.

· Act as a mentor for other CRDs and Clinical Scientists on the same project/TA.

About you

Experience: Excellent expertise in clinical development and methodology of clinical studies. Understanding of pharmaceutical product development and life cycle management gained through at least 10 years of

development and clinical experience. Strong scientific and clinical background with deep understanding of the therapeutic field.

· Soft and technical skills: Excellent communication, problem solving and decisions making skills for interactions across functional areas and for interactions with key regulatory agencies. Strong leadership and collaboration abilities, including the capacity to inspire and guide cross functional teams towards achieving project and team goals.

Education: Medical Doctor (MD) and specialist training

·Languages: English fluent (spoken and written)

Skills that you could improve in this new position

Experience: Expertise in clinical dossier submission as well as interactions with health authorities

Soft and technical skills: Develop strong leadership qualities, strengthen collaboration skills, and enhance the ability to work within a matrix model to achieve Sanofi goals.

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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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.