Job title: Clinical Research Director
Location: Cambridge, MA / Morristown, NJ (Hybrid)
Reporting to the Global Project Head, the CRD leads clinical trial strategy of assigned program(s) within the clinical development team, including interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. The clinical development team further develops a compound through life cycle management.
Main ResponsibilitiesEstablishes 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 YouJob Requirements:- MD degree or equivalent.
- Minimum 3 years industry or academic clinical development experience
- Hematology/Oncology experience preferred
- 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 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.
The salary range for this position is:
$206,250.00 - $343,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
