Clinical Pharmacology Associate

How you’ll make an impact:
- Conduct routine non-compartmental analysis of PK data
- Assist in the authorship and review of clinical pharmacology documents (e.g., protocols, study reports, analysis plans)
- Create study/protocol templates and best practices for Clinical Pharmacology studies
- Coordinate end-to-end logistics for pharmacokinetic (PK) samples from clinical sites to central and specialty laboratories
- Track sample shipments, reconciliation, and issue resolution to ensure sample integrity and protocol compliance
- Maintain and QC sample tracking systems and study-specific trackers
- Collaborate with Clinical Operations and vendors to proactively address logistical challenges
- Support identification, selection, and onboarding of external laboratories and vendors
- Manage day-to-day vendor interactions to ensure timely and high-quality data delivery
- Track vendor performance against timelines, scope, and budget
- Assist with contract scope review, budget tracking, and invoice reconciliation
- Develop and QC laboratory manuals, sample handling guidelines, and site training materials
- Support creation and maintenance of study-specific documentation and trackers
- Ensure documentation aligns with protocols, regulatory expectations, and internal standards
- Contribute to development of data transfer documents
- Support development, implementation, and maintenance of SOPs and QC processes within Clinical Pharmacology
- Drive continuous improvement initiatives to enhance operational efficiency and compliance

Skills and experience you’ll bring:
- Pharm D., B.S/M.S in pharmaceutical sciences or other related fields
- 3+ years of experience in clinical research, clinical operations, or clinical pharmacology (biotech or pharmaceutical preferred)
- Working knowledge of pharmacokinetic principles and/or PK analysis (preferred)
- Experience managing PK or clinical sample logistics, including central lab coordination and sample tracking
- Demonstrated experience working with and managing external vendors/CROs
- Familiarity with GCP and regulatory requirements for clinical trials and bioanalytical sample handling
- Strong organizational skills; ability to manage multiple priorities and timelines
- High attention to detail; commitment to data quality and compliance
- Effective communication and collaboration skills; ability to work cross-functionally
- Proficiency with clinical trial systems and tools (e.g., sample tracking systems, CTMS, Excel)

Compensation:
- Anticipated base salary range: $85,000-$150,000; eligibility for annual bonus, equity participation, and comprehensive benefits.