Job Description
Join BioNovate Therapeutics, a global leader in innovative drug development, as we pioneer the next generation of therapeutics. We're seeking a dynamic Senior Clinical Research Manager to oversee pivotal clinical trials in our oncology division. This role offers the opportunity to shape clinical strategy, lead cross-functional teams, and bring life-changing treatments to patients worldwide. Our Cambridge, MA headquarters features state-of-the-art laboratories and a collaborative environment where scientific excellence meets commercial impact.
Responsibilities
- Design, implement, and monitor global Phase II-III clinical trials in oncology
- Lead cross-functional teams including CRAs, biostatisticians, and medical monitors
- Ensure regulatory compliance (ICH-GCP, FDA guidelines) across all trial activities
- Manage clinical trial budgets, timelines, and vendor relationships
- Develop comprehensive clinical trial protocols and study reports
- Collaborate with regulatory affairs to support IND/IMPD submissions
- Analyze clinical data and contribute to publication strategy
Qualifications
- MS/PhD in life sciences or related field with 8+ years clinical research experience
- Proven track record managing oncology clinical trials from Phase II to submission
- Deep understanding of FDA/EMA regulations and GCP standards
- Experience with EDC systems (Medidata Rave, Oracle Clinical)
- Strong leadership skills with ability to manage remote teams
- Certified Clinical Research Professional (CCRP) or equivalent preferred
- Exceptional communication and stakeholder management abilities