Associate Principal Scientist, Clinical Research
$142.4k - $224.1kMerck
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
Vacancy posted 7 days ago
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