Manager, Pharmacokinetic Lab

START Center for Cancer Research • San Antonio, TX

24d • Onsite

About The Position

The Manager, Pharmacokinetic Lab serves as a liaison between START US Sites and pharmaceutical sponsors, providing information about the collection, processing, handling, storage, and shipment of research and clinical laboratory samples. The role helps ensure successful protocol execution in accordance with department SOPs and provides oversight of laboratory operations, facilities, SOPs, and quality metrics. The position is located at 4383 Medical Dr, San Antonio, TX 78229, and follows a Monday-Friday, 8:00 a.m.-5:00 p.m. schedule.

Requirements

• Bachelor’s degree in chemical, physical, biological, or clinical laboratory science, or medical technology.
• At least five years of experience in a laboratory setting.
• Quality management skills, including personnel management, financial management, and process management.
• Experience with electronic medical record programs and laboratory information systems.

Nice To Haves

• Prior experience in Phase I clinical trials.
• Knowledge of GCP, GDPR, and federal clinical research regulations in the United States.
• Experience in data management, logistics, and operations.

Responsibilities

• Oversee sample processing by PK Lab Technicians and take appropriate corrective action to address inconsistencies in collection data.
• Create SOPs for the PK Department and Tumor Bank and conduct an annual review or update.
• Oversee or delegate training of PK Department staff on SOPs at least annually, when new SOPs are written, and when updates occur.
• Ensure compliance with applicable federal, state, and local laws and regulations governing biological sample processing, handling, and shipping.
• Maintain accurate patient, study/protocol, and sponsor files.
• Hire, train, and develop employees; supervise all personnel and new hires.
• Oversee and complete study forms, including PK flowsheets, shipping logs and documentation, sample requisition forms, flow sheets, and sample manifests.
• Track Site Initiation Visits, protocol amendments, and laboratory manual updates.
• Participate in Protocol Development and Review Committee meetings by reviewing and commenting on all Phase I investigational protocols received by START.

Benefits

• 401(k) retirement savings plan with employer match.
• Eligibility for an annual performance bonus, based on role and company results.
• Generous paid time off and paid holidays.
• Medical, dental, and vision coverage, with optional insurance options.
• Company-paid life and disability insurance.
• Employee Assistance Program providing confidential, no-cost support for employees and their families from day one.
• Flexible FSA and HSA plans.
• A supportive environment that values balance, wellbeing, and flexibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager