Job Description
Join MediGen Innovations, a leader in precision medicine, as we pioneer groundbreaking treatments for chronic diseases. Our Boston-based team combines cutting-edge technology with compassionate care to transform patient outcomes. We seek a visionary Senior Clinical Research Manager to lead pivotal trials in our oncology division. Enjoy state-of-the-art facilities, collaborative cross-functional teams, and opportunities to publish in top-tier journals. What you'll achieve: Design and execute Phase II-III clinical trials, ensure protocol compliance, and drive FDA submissions while mentoring junior researchers. Why MediGen: Comprehensive health benefits, 15% annual bonus potential, and $5k annual professional development allowance.
Responsibilities
- Lead cross-functional teams in designing and executing Phase II-III oncology clinical trials
- Ensure GCP/ICH compliance across 15+ global trial sites
- Analyze complex patient data using SAS/R to support FDA submissions
- Mentor 3-5 junior researchers and manage $2M+ trial budgets
- Collaborate with biostatisticians to develop statistical analysis plans
- Present findings at FDA advisory committees and international conferences
- Optimize patient recruitment strategies achieving 90%+ enrollment targets
Qualifications
- PhD or PharmD in Clinical Research, Pharmacology, or related field
- 8+ years of oncology clinical trial management with 3+ leadership roles
- Proven track record of 5+ successful IND/BLA submissions
- Expertise in oncology biomarker analysis and adaptive trial design
- Certified CRA (ACRP) or equivalent with active license in Massachusetts
- Published author in peer-reviewed journals (minimum 3 oncology studies)
- Advanced proficiency in EDC systems (Medidata Rave) and statistical software