Clinical Research Director

BioSpace; Cambridge (MA); In loco; USD 180.000 - 240.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

14 weeks parental leave

Descrizione del lavoro

Sanofi in Cambridge, MA is seeking a Clinical Research Director to drive late-stage oncology development and strategic clinical execution. The role collaborates with investigators, regulatory bodies, and cross-functional teams to optimize study design, conduct and interpretation of outcomes.

The position emphasizes interaction with external investigators, regulatory planning, and producing clinical study reports while ensuring compliance with healthcare standards and company policies.

Competenze

• MD degree or equivalent.
• Hematology/Oncology fellowship or minimum 4 years experience in Oncology Development.
• Expertise in pharmaceutical medicine based on minimum 3 years industry or academic clinical research experience.

Mansioni

• Establishs or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.
• Leads, supports and oversees the execution of clinical development and studies activities.
• Authors abbreviated protocol and reviews protocol documents and amendments.
• Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.
• Reviews study committees and leads study specific committees with operational support.
• Leads clinical interpretation of study results and contributes to clinical study reports and summaries.
• Provides clinical guidance to Clinical Operations, Biostatistics and Translational Medicine.
• Participates in regulatory and safety documents and discussions including Investigator Brochure, IND/IMPD filings, DSUR, and development risk management plans.
• Contributes to clinical sections of NDA/CTD and briefing packages for regulatory meetings.
• Participates in Advisory Committee preparation.

Formazione

MD degree

Hematology/Oncology fellowship

3+ years pharma/academic clinical research experience

Descrizione del lavoro

About The Job

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.

Job title: Clinical Research Director

Location: Cambridge, MA

About The Job

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

• Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.
• Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to:
• Authors abbreviated protocol.
• Reviews the final protocol and protocol amendments.
• Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.
• Reviews the study specific committee charters. Leads study specific committees with operational support.
• Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries.
• Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine.
• Participates and contributes to regulatory and safety documents and discussions:
• Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans.
• Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIP.
• Participates in Advisory Committee preparation.

Scientific Data Evaluation And Authorship

• Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate.
• Supports the planning of advisory board meeting. Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate.

About You

• MD degree or equivalent.
• Hematology/Oncology fellowship or minimum 4 years experience in Oncology Development.
• Expertise in pharmaceutical medicine based on minimum 3 years industry or academic clinical research experience.

Experience In Late-stage Clinical Development Preferred.

• Demonstrated ability to interact productively with external investigators.
• Demonstrated ability to work with a multifunctional team to achieve project milestones.
• Understanding of and willingness to meet applicable regulatory, quality and compliance standards.

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 Inc. and its U.S. affiliates are Equal Opportunity and Affiliated 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.

#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.