Manager, 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 a Manager, 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 
• Responsible for sample logistics (including forecasting, tracking, storage, and analysis of kits and samples). Ensure ongoing compliance with clinical protocols, and with ICH E6(R2), HIPAA and other applicable regulations pertaining to informed consent and collection of research samples from clinical trial participants (in multiple regions preferred).
• Manage external laboratory vendors, including identification, onboarding, and training within your area of responsibility.
• Develop and manage sample tracking tools for internal monitoring of sample accrual and status.
• Contribute to the development of documents that pertain to biosample collection, handling, and storage including clinical study protocols, ICFs, and lab manuals
• Develop and deliver training to site personnel to ensure compliance with sample collection, processing, and shipment requirement.
• 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.
• Able to travel up to 10% of the time. Successfully manage through and drive change, and eager to grow with the company.

Job Requirements
• BA/BS degree with at least 5 years clinical trial experience (including oncology drug development)
•Minimum of 2 years of biosample management experience is preferred
• Working knowledge of ICH/GCP and regulatory guidelines/directives strongly preferred.
• Working knowledge of CLIA/CAP regulations and GLP guidelines strongly preferred.
• Experience managing central and specialty labs, including negotiating scope of work and budget
• Experience in biosample management at a biotech/pharmaceutical company or CRO is desirable.
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.