About the role
AI summarisedThe Associate Director or Director of Clinical Operations leads pharmacology and biomarker development initiatives, overseeing study execution and external vendor relationships. This role ensures that clinical programs adhere to regulatory standards while managing complex sample logistics and data integrity for biomarker-driven trials.
BiotechOnsiteClinical Development
Key Responsibilities
- Oversee clinical operations for pharmacology and biomarker development studies from study planning through close-out
- Manage performance and relationships with Clinical Research Organizations (CROs) and specialized biomarker laboratories
- Ensure all clinical trial activities comply with study protocols, SOPs, GCP guidelines, and regulatory requirements
- Lead the development and implementation of biomarker sample collection, processing, and shipping manuals
- Manage study-specific budgets, contract negotiations, and financial forecasting for biomarker activities
- Coordinate with cross-functional teams in Research, Translational Medicine, and Clinical Development to align study objectives
- Monitor study milestones and implement risk mitigation strategies to ensure timely delivery of biomarker data
Requirements
- Bachelor’s or higher degree in Life Sciences, Pharmacology, or a related scientific discipline
- Minimum of 8 to 10 years of clinical operations experience within the pharmaceutical or biotechnology industry
- Extensive knowledge of Good Clinical Practice (GCP) and international regulatory requirements for clinical trials
- Proven experience managing biomarker-driven clinical trials or complex pharmacology studies
- Demonstrated proficiency in managing CROs and external specialty vendors
- Experience with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms
- Strong leadership and project management skills with the ability to oversee multiple clinical programs
- Understanding of Phase I and Phase II clinical trial design and execution requirements
- Strong communication skills for effective interaction with internal stakeholders and external investigators
- Ability to navigate high-growth, fast-paced environments with evolving priorities
- Knowledge of sample logistics and cold chain management for biological specimens