Job Description
Join NovoMed Therapeutics, a global leader in innovative pharmaceutical solutions, as we pioneer next-generation therapies. We're seeking a visionary Senior Clinical Research Manager to drive our oncology clinical trials from protocol design to FDA submission. This role offers unparalleled opportunities to shape life-saving treatments while working with world-class scientists in our state-of-the-art Cambridge facility. Enjoy competitive compensation, comprehensive benefits, and a culture that values scientific excellence and patient impact.
Responsibilities
- Lead end-to-end clinical trial management for Phase II-III oncology studies across 5+ global sites
- Develop and execute innovative clinical strategies aligned with FDA/EMA regulatory requirements
- Manage cross-functional teams including biostatisticians, data managers, and regulatory affairs specialists
- Oversee clinical trial budgets exceeding $2M, ensuring financial compliance and resource optimization
- Drive site selection, initiation, and monitoring with 95% protocol adherence rate
- Author critical regulatory documents (IB, protocol, CSR) meeting GCP standards
- Represent NovoMed at key scientific conferences and industry partnerships
Qualifications
- PhD or PharmD in life sciences with 8+ years clinical research experience in oncology
- Proven track record managing global Phase II-III trials with 2+ successful IND/BLA submissions
- Certified CRA or equivalent (ACRP/SoCRA) with deep GCP/ICH expertise
- Exceptional leadership skills demonstrated in matrix organizations
- Strong statistical literacy and clinical data interpretation abilities
- Advanced proficiency in eCRF systems (Medidata Rave) and clinical trial management platforms
- Published research in peer-reviewed oncology journals preferred