Associate Principal Scientist, Clinical Research

Merck seeks an Associate Principal Scientist to lead early-phase clinical trial design, planning, and execution within Translational Medicine. The role combines scientific oversight, regulatory compliance, technical writing, and cross-functional project management to advance novel therapeutics from first-in-human studies through proof-of-concept.

Responsibilities

• Design, plan, and execute early-phase clinical trial strategies spanning first-in-human through proof-of-concept studies
• Provide operational and scientific oversight of trial conduct, ensuring compliance with GCP, ICH, and regulatory requirements
• Author clinical protocols, investigator brochures, study reports, regulatory submissions, and related clinical documentation
• Lead cross-functional teams through study planning, execution, issue mitigation, and governance meetings under accelerated timelines
• Conduct on-site monitoring, safety assessments, and risk management for novel compounds and complex biomarker collection processes

Requirements

• Bachelor's degree in life sciences with ≥11 years related experience, or Master's with ≥8 years, or PhD with ≥3 years
• At least 6 years clinical trial experience in clinical scientist or clinical operations role
• Demonstrated expertise in clinical program development, trial execution, and project management across multiple priorities
• Strong medical/scientific writing and regulatory reporting skills with GCP and ICH guideline knowledge
• Ability to mentor junior staff and lead cross-functional initiatives addressing business gaps or process improvements
• Proven capability to work independently across functional areas, manage complex problems, and escalate issues proactively