Principal Clinical Research Director, I and I

Job Title: Principal Clinical Research Director, I and I

Grade: L5
Hiring Manager: Christopher Soria

Location: Cambridge, MA   Morristown, NJ

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. 

The Principal Clinical Research Director (CRD) is noted as the primary clinical lead for complex priority projects, especially those with multiple indications. The role requires a highly resourceful individual with outstanding strong emotional intelligence, self-motivation, solid analytical skills and the ability to be a strong leader.  The candidate is considered a “Top-Class” expert in the respective therapeutic area.

The anti-TL1A project is a co-development partnership with TEVA, with a primary focus in inflammatory bowel diseases and with planned indication expansion in immune driven and fibrotic diseases.

This role is highly strategic and facilitative that requires a combination of focus and flexibility, as well as a willingness to play an active role to support clinical activities across the project.  The role requires leading a team to support continued clinical activities across a complex project while supporting other CRDs at the team level.  Principal CRD should be a key partner to the Global Project Head with a focus on clinical activities and supporting design and strategy for evidence generation. 

We 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?​

Main Responsibilities:

• Support the project activities by focusing on the strategic clinical approach to the collective project

• Strong leadership skills and be able to manage a team of expert CRDs supporting the collective project

• Support the team with key interactions from other functions (i.e. Regulatory, Medical, Pharmacovigilance… and other key functions)

• Oversight and support the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results Memo, Clinical Study Report)

• Support the TA CRDs with other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)

• Contribute to the clinical part of Common Technical Document for any regulatory submissions

• Key role in participating and aligning on standardizations and activities in for the Protocol Review Committees

• Medical /clinical reference in the project, ensuring the medical relevance of the clinical data across all studies with the project.

• Key medical / clinical reference for the project, ensures operational delivery (e.g. harmonizing study documents, ES, protocols, etc.), as relevant, within a project, ensures leadership, builds consensus, coordinates action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to the Global Project Head and TA Head as relevant

About You

Experience

• Broad understanding of pharmaceutical product development and life cycle management gained through 6-8 years of development and medical experience

• Outstanding scientific and medical expertise

• Outstanding expertise in clinical development and methodology of clinical studies

• Demonstrated strong leadership, foster team motivation, ability to influence and drive decisions

• Outstanding communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies

• Demonstrated capability to challenge decision and status quo with a risk-management approach

• Ability to negotiate to ensure operational resources are available for continued clinical conduct

• Fluency in written and spoken English

• Outstanding understanding of Clinical Study conduct and medical affairs activities (global and local)

• Outstanding intercultural/international working skills

• Open and preferably experienced in digital solutions

Minimum Level of any Required Qualifications:

• Medical Doctor (MD): Gastroenterologist and/or deep experience treating GI and IBD related diseases.

• English fluent (spoken and written)

• At least 6 to 8 years in pharmaceutical industry or CRO, previous experience in clinical development

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.