Associate Director, Biosample Operations

Who We Are
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers.

The Position
Bolt Biotherapeutics has an exciting opportunity for an Associate Director, Biosample Operations, to provide Biosample Operations support for Bolt’s pipeline. You will manage contract execution and vendor oversight for central and specialty labs, ensure accurate forecasting and tracking of trial samples and drive delivery of critical translational data to support Bolt’s clinical portfolio.

Key Responsibilities
• Collaborate with the clinical study teams and CROs to perform biomarker and real-time tracking of samples collected in Bolt clinical trials
• Responsible for sample logistics (including forecasting and tracking sample collection, receipt, and retention). Ensure ongoing compliance with clinical protocols, and with GCP, HIPAA and other applicable guidance and regulations pertaining to informed consent and collection of research samples from clinical trial participants (in multiple regions preferred).
• Provide timely updates to clinical study teams and Bolt Clinical Development.
• Coordinate sample movements needed for analysis or long-term storage.
• Liaise with Clinical Data Management, Clinical Operations and Clinical Development to ensure timely resolution of biomarker-related data reconciliation, and sample-related issues at sites or analysis labels
• Manage the lifecycle of biomarker samples to ensure that samples are used and/or stored appropriately per the associated ICFs
• Manage external central and specialty laboratory vendors, ensuring tight coordination of sample shipment to and timely receipt of data from vendors
• Develop and manage sample tracking tools to ensure ongoing visibility into sample accrual and status
• Author and/or review documents that pertain to sample collection, handling, and storage including clinical study protocols, ICFs, and lab manuals
• Work closely with the clinical study teams to address informed consent and IRB/EC questions related to biosamples
• Develop and deliver training to site and study personnel as needed, to ensure compliance with sample collection, processing, and shipment requirements
• Analyze trending in sample collection and quality, and trigger retraining or other interventions as necessary to ensure ongoing compliance with trial-specific sample collection, processing, and shipping procedures
• Identify and develop standard operating procedures (SOPs) and work instructions (WIs) to ensure consistent and compliant execution of Biosample Operations at Bolt.
• Able to travel up to 10% of the time
• Successfully manage through and drive change

Job Requirements
• BA/BS degree with at least 8 years clinical trial experience (including oncology drug development)
• Minimum of 4 years of biosample management experience is preferred
• Working knowledge of ICH/GCP and regulatory guidelines/directives
• Working knowledge of CLIA/CAP regulations and GLP guidelines
• Experience managing central and specialty labs, including negotiating scope of work and budget
• Experience in biosample management at a pharmaceutical company or CRO is strongly preferred
• Experience managing others is preferred
We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.