Job Description
Join BioPharm Innovations Inc., a global leader in oncology therapeutics, as we pioneer groundbreaking treatments that transform patient lives. Our Boston-based research division is seeking a visionary Senior Clinical Research Manager to lead pivotal Phase II-III trials for novel immunotherapies. You'll collaborate with cross-functional teams to ensure protocol execution excellence while driving regulatory compliance and data integrity. This role offers unparalleled opportunities to shape clinical development strategies and mentor emerging researchers in a dynamic, science-driven environment.
Responsibilities
- Design and oversee global clinical trial protocols, ensuring alignment with FDA/EMA regulations and GCP standards
- Lead cross-functional teams including CRAs, biostatisticians, and medical writers to drive trial execution milestones
- Manage clinical trial budgets exceeding $5M and optimize resource allocation across 10+ sites
- Develop comprehensive risk mitigation plans and resolve critical operational challenges proactively
- Interface with regulatory authorities to address safety reports and ensure compliance with 21 CFR Part 812
- Present trial progress and safety data to executive stakeholders and FDA advisory committees
- Mentor junior staff and implement continuous improvement initiatives for clinical operations
Qualifications
- PhD or PharmD in Life Sciences with 8+ years of clinical research experience, including 4+ years in oncology
- Proven track record managing Phase II-III oncology trials with complex endpoints (e.g., OS, PFS)
- Expertise in EDC systems (Medidata Rave) and risk-based monitoring methodologies
- Strong knowledge of ICH-GCP, FDA regulations, and international clinical trial standards
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Demonstrated success in leading multi-site trials across 3+ countries
- Exceptional problem-solving skills in resolving protocol deviations and site activation bottlenecks
- Fluency in regulatory submission processes (IND/IMPD) and safety signal management