Associate Principal Scientist, Clinical Research

Merck seeks an Associate Principal Scientist to lead clinical operations for early-phase immunology trials, spanning Phase 1 and 1b studies. The role involves designing clinical strategies, managing cross-functional teams, ensuring regulatory compliance, and authoring clinical documents and protocols.

Responsibilities

• Lead clinical operational execution and planning of early-phase immunology trials in partnership with Clinical Directors
• Author clinical protocols, investigator brochures, study reports, and regulatory submissions
• Develop study operational documents including monitoring plans, informed consents, and laboratory manuals
• Oversee clinical safety assessment, risk management, and real-time trial oversight to identify and mitigate issues
• Represent early-stage development on product development teams and lead departmental process improvements

Requirements

• Bachelor's degree in life sciences with 11+ years related experience, or Master's with 8+ years, or PhD/doctorate with 3+ years
• Minimum 3 years Phase 1 clinical trial experience
• Experience developing and managing immunology clinical programs in healthy participants and/or patients
• Strong project management skills with ability to balance multiple priorities and complex timelines
• Expertise in scientific and medical writing, clinical protocols, and regulatory documentation
• Working knowledge of GCP, ICH guidelines, and regulatory requirements
• Ability to mentor junior staff and lead cross-functional teams