Job Description
Join BioVance Therapeutics, a leader in innovative pharmaceutical solutions, as we pioneer next-generation therapies for rare diseases. We seek a dynamic Senior Clinical Research Manager to lead pivotal clinical trials and accelerate drug development timelines. This role offers unparalleled opportunities to shape the future of medicine while collaborating with world-class scientists in our state-of-the-art Cambridge facility.
Why BioVance? We offer competitive compensation, comprehensive benefits, and a culture that values scientific excellence and professional growth. Our Cambridge location provides access to Harvard's research ecosystem and a thriving biotechnology community.
Responsibilities
- Design and execute Phase II-III clinical trials for novel therapeutics
- Lead cross-functional teams including CROs, regulatory affairs, and data management
- Ensure protocol compliance and FDA/EMA regulatory standards
- Analyze trial data and prepare regulatory submissions
- Manage clinical trial budgets and vendor relationships
- Mentor junior research staff and develop SOPs
Qualifications
- PhD or PharmD with 8+ years clinical research experience
- Proven track record in oncology or rare disease trials
- Certified Clinical Research Professional (CCRP) or equivalent
- Expertise in ICH-GCP and FDA regulations
- Strong statistical analysis and data interpretation skills
- Experience with EDC systems (e.g., Medidata Rave)
- Exceptional leadership and stakeholder management abilities