Job Description
Join BioPharm Innovations Inc., a leader in groundbreaking pharmaceutical research, as our Senior Clinical Research Manager. This pivotal role drives the execution of global clinical trials, ensuring compliance with FDA/EMA regulations while accelerating therapeutic innovations to market. You'll lead cross-functional teams, mentor junior researchers, and contribute directly to life-changing drug development.
Our Princeton headquarters offers state-of-the-art facilities, collaborative workspaces, and a culture that values scientific excellence. Enjoy competitive benefits, flexible work arrangements, and opportunities to present at international conferences.
Responsibilities
- Design and oversee Phase I-III clinical trial protocols across multiple therapeutic areas
- Manage $5M+ budgets and vendor relationships for CRO partnerships
- Ensure regulatory compliance with GCP, FDA 21 CFR Part 312, and ICH guidelines
- Lead cross-functional teams (medical, regulatory, data science) to achieve milestones
- Interpret complex clinical data and prepare FDA/EMA submissions
- Mentor junior researchers and conduct site audits for protocol adherence
- Present trial outcomes to executive stakeholders and investor groups
Qualifications
- PhD or PharmD in Life Sciences with 8+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record leading global oncology/neurology trials
- Expertise in FDA/EMA regulatory submissions and risk-based monitoring
- Strong proficiency in EDC systems (Medidata Rave, Veeva Vault)
- Exceptional project management skills with PMP certification preferred
- Published research in peer-reviewed pharmaceutical journals
- Ability to travel 20% internationally for site monitoring