Associate Director, Clinical 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, within Clinical Operations. The successful candidate will be responsible to ensure clinical trial strategy is executed on time, within budget, and of high quality.
 
 Key Responsibilities
• Lead the overall clinical operations activities across all clinical studies for a clinical development program
• Demonstrate exceptional vendor management skills, including CRO identification, scope negotiation and management, delegation, and follow-through in support of trial and program deliverables
• Build strong relationships with clinical sites and primary investigators, facilitating timely site activation, enrollment, and data delivery
• Assist in the identification and development of Clinical Operations staff and infrastructure
• Ensure ongoing regulatory and GCP compliance (i.e., inspection ready at all times)
• Responsible for coordinating internal and managing external cross-functional activities to ensure delivery of critical clinical deliverables, including development of trial documents (e.g., informed consent forms (ICFs); protocols; site and country budget templates; EDC, IRT, central/specialty lab, ECG, imaging, and PRO specifications; drug supply and biomarker/sample management plans; and CSRs) and delivery of trial data (e.g., ongoing data capture, cleaning and availability, periodic and ad hoc generation of interim data, etc.)
• Develop and manage project timelines (utilizing MS Project or equivalent software), study budgets, and study plans
• Periodically report project status to senior management
• Contribute to site selection
• Contribute to the development and active management of study-specific patient recruitment strategies
 
  Job Requirements
• BA/BS degree with at least 8 years clinical trial management experience (including oncology drug development, I/O preferred)
• Must have strong knowledge of ICH/GCP guidelines
• Must have strong knowledge of clinical drug development processes, clinical study design, study planning and management, and monitoring
• Strong experience in management of CROs and other vendors
• Proven project management skills and study leadership ability
• Excellent interpersonal, written, and verbal communication skills
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
• Experienced in managing aspects of one or more early development phase (I and II),
• global, complex, clinical studies and generally experienced in clinical research/development
• Self-motivated, achievement-driven and exhibits ability to work with minimal guidance
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.
 
Bolt Biotherapeutics requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Bolt will consider requests for Reasonable Accommodations.
 
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.