Job Description
Join BioVance Therapeutics, a leader in innovative pharmaceutical solutions, as we pioneer next-generation therapies for rare diseases. We're seeking a dynamic Senior Clinical Research Manager to lead critical trials and shape the future of patient care. You'll collaborate with cross-functional teams in our state-of-the-art Cambridge facility, driving excellence in clinical trial execution from Phase I to Phase III. Enjoy competitive compensation, comprehensive benefits, and the opportunity to make a tangible impact on global health outcomes.
Responsibilities
- Design and oversee global clinical trial protocols for novel therapeutics
- Lead cross-functional teams including CROs, investigators, and regulatory affairs
- Ensure compliance with FDA/EMA GCP and ICH guidelines
- Manage clinical trial budgets exceeding $5M and vendor relationships
- Analyze complex trial data and prepare regulatory submissions
- Mentor junior researchers and optimize clinical operations workflows
Qualifications
- MS/PhD in Life Sciences, Pharmacy, or related field with 8+ years clinical research experience
- Proven track record managing Phase II-III trials in rare diseases or oncology
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in EDC systems (e.g., Medidata Rave) and risk-based monitoring
- Strong knowledge of 21 CFR Part 312 and ICH-GCP regulations
- Exceptional leadership skills with experience managing matrix teams