Anatomic Pathology Manager-Clinical Trials

Job Title: Anatomic Pathology Manager for Clinical Trials

Full-time

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position Overview:

The Anatomic Pathology Manager for Clinical Trials will play a pivotal role in managing and overseeing the anatomic pathology aspects of clinical trials. This position requires a unique combination of technical expertise in pathology, particularly immunohistochemistry (IHC), and strong project management skills. The successful candidate will collaborate closely with pathologists, project managers, and other stakeholders to ensure the seamless integration of anatomic pathology services into our clinical trial projects.

The Anatomic Pathology Manager for Clinical Trial will be responsible for day to day activities in building and maintaining Central Lab Services at Frontage Laboratories to include:

- Oversee the anatomic pathology operations for clinical trials.

- Coordinate with project managers to ensure timely and accurate execution of pathology-related tasks within clinical trials including invoicing

- Monitor project timelines and deliverables, ensuring adherence to deadlines and quality standards.

- Creation, revision and maintenance of Standard Operating Procedures.

- Validate all new IHC testing (partnering with in house pathologist) according to CAP, CLIA and FDA regulations depending on the intended application of the IHC marker

- Collaborate with outside vendors to ensure referral testing is performed according to Frontage laboratory requirements.

- Perform QC/QA on all laboratory testing to include routine histology, special stains and immunohistochemistry.

- Validate IHC assays maintaining CAP and CLIA compliance; keep clear, concise optimization and validation records.

- Procure all supplies and reagents and manage inventory and maintain all Histology equipment.

- Select new instrumentation as necessary, and work with vendors to maintain all existing instrumentation.

- Provide leadership and training to all new technicians and ensure technical competency of the histotechs.

Qualifications:

• Qualified to be a CLIA Technical Supervisor for Histology Lab or CLIA High Complexity Testing Personnel in PA
• More than 5 years work experience working in a Histology lab including general histology and IHC.
• Experience in managing clinical trials, particularly in a pathology setting.
• Excellent communication and interpersonal skills.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.