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BioSpace

Senior Clinical Research Director

cambridge, MA

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Job description

Job title : Senior Clinical Research Director

Location: Cambridge, MA

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, where you will serve as the primary Clinical Lead for the fitusiran registrational development program and ongoing global regulatory submissions. Qfitlia (fitusiran) is a first-in-class antithrombin-lowering therapy approved in the United States and multiple countries for the prophylactic treatment of adults and adolescent patients with hemophilia.

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.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

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 Sanofis policies and procedures.

Foster a collaborative, engaging, and high-performing team environment for Clinical Research Directors and Clinical Scientists.

About You

Minimum Requirements:

Medical Doctor or equivalent with specialist training in Hematology, Internal Medicine, Pediatrics, or other relevant specialty

Minimum 8 years experience

Basic Qualifications

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

Expertise in clinical development and methodology of clinical studies

Understanding of pharmaceutical product development and life cycle management

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.

English fluent (spoken and written)

Preferred Qualifications

MD/PhD degree

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 its 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.

Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

Help improve the lives of millions of people globally by making drug development quicker and more effective.

Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

#GD-SA #vhd

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.

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Worksite address

cambridge, MA, 02140, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.

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