Clinical Trials Central Laboratory and Bioanalysis Manager

Clinical Trials Central Laboratory and Bioanalysis ManagerOncoC4 is a late-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. Our leading clinical candidate is ONC-392, a next generation anti-CTLA-4 antibody capable of uncoupling cancer therapeutic effect from immunotherapy-related adverse effect. ONC-392 is currently evaluated in Phase 2 and Phase 3 studies as a single agent and in combination in advanced solid tumors.Position Summary:The position is part of the translational research group at OncoC4, Inc. It includes both overseeing OncoC4 in-house clinical trial central lab as well as overseeing bioanalysis of PK and ADA for clinical samples by CRO.

Responsibilities· Directly supervise, support, train and mentor staff. Maintain daily central lab performance by managing resources, prioritizing tasks, and developing and monitoring metrics. · Work with QA to create onboarding plan and continuous training and mentorship. · Ensure Standard Operating Procedures (SOP) are reviewed, maintained, and followed. · Working with QA to facilitate quality issue resolution, including change control and deviation management. · Perform duties with general effective working knowledge of GCP and GCLP and other pertinent regulations, as it pertains to central laboratory functions. · Suggest, validate, and implement service improvements to ensure efficiency and continued growth of the organization.· Review, interpret, and monitor compliance with pertinent regulations/standards. · Supervise and validate accuracy of samples records in inventory platform and shipping manifests.· Oversee development and execution of GCLP bioanalysis of pharmacokinetic (PK) and anti-drug-antibodies (ADA) done by a CRO· Oversee timely supply of critical reagents for continuous testing of bioanalysis assays by CRO. Initiate bridging studies as needed.· Oversee record reconciliation when needed.

Minimum Required:· Bachelor's Degree (Biology, Life Sciences or other related discipline). M.Sc. / Ph.D. preferred· 6+ years of relevant experience in clinical specimen management, life science laboratory or similar setting· 2+ years of supervisory or team lead experience· Experience working with human samples including PBMCs. Other Required:Requires good attention to detail, excellent documentation skills and willingness to work well in a group environmentAbility to interact and function in a highly productive work environmentAbility to work independentlyMust be proficient using Microsoft office, specifically with ExcelAbility to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC)Must be able to read, write, speak fluently and comprehend the English languageMust be reporting to work on site, not a remote positionPreferred:Clinical Laboratory Management / Technologist certificateKnowledge in clinical pharmacology