Job Description
Join BioGenix Therapeutics at the forefront of pharmaceutical innovation as we pioneer groundbreaking therapies to transform patient lives. We seek a dynamic Senior Clinical Research Manager to lead pivotal clinical trials, ensuring regulatory compliance and driving therapeutic breakthroughs. In this high-impact role, you'll orchestrate cross-functional teams, oversee complex protocols, and shape the future of medicine.
Our Cambridge headquarters offers a collaborative environment where scientific excellence meets cutting-edge technology. You'll work alongside industry leaders in state-of-the-art facilities while enjoying competitive compensation and comprehensive benefits. If you're passionate about accelerating drug development and making a tangible difference in healthcare, we invite you to apply.
Responsibilities
- Design and execute Phase I-IV clinical trial protocols aligned with FDA/EMA regulatory standards
- Lead cross-functional teams including CRAs, biostatisticians, and medical writers
- Oversee site selection, monitoring, and audit processes for global trial sites
- Manage clinical budgets and ensure compliance with GCP and ICH guidelines
- Collaborate with regulatory affairs on IND submissions and safety reporting
- Develop risk mitigation strategies and troubleshoot operational challenges
- Present trial data to executive stakeholders and regulatory authorities
Qualifications
- Master's or PhD in Life Sciences, Pharmacy, or related clinical research field
- 8+ years of clinical research experience with 3+ years in leadership
- Proven track record of managing global Phase II-III trials in therapeutic areas
- Deep expertise in FDA/EMA regulations and GCP compliance
- Strong proficiency in CTMS systems (e.g., Veeva, Oracle) and EDC platforms
- Certification in clinical research (ACRP/SoCRA) preferred
- Exceptional project management and stakeholder communication skills