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 cancer.
Reporting directly to the VP of Clinical Development and working closely with the Medical Directors. The candidate with serve as the primary source of clinical oversight of one or more early phase clinical trials.
• Will participate in the execution of assigned clinical trial activities and work closely with clinical team members within the assigned project(s) to execute activities associated with the conduct and oversight of Bolt clinical trials
• Working with the Medical Directors to support trial level activities for one or more trials
• Review clinical narratives
• Monitor clinical data for accuracy of critical clinical endpoints and safety
• Contribute to Medical Data Review Plan in collaboration with Data Management
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Contribute/author clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory
• Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission)
• Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols
• Writing of technical and clinical documents including protocols, amendments, investigator’s brochures, informed consent forms, and the clinical sections of regulatory documents
• Responsible for development, training, implementation and compliance of Standard Operating Procedure
• Conduct literature reviews as needed
• Provide organizational support and clinical data content for Data Monitoring Committees other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports
• BA/BS required in a scientific/medical field or equivalent work experience, advanced degree preferred
• At least 8 years of experience in managing global clinical trials at all stages of development within the biopharma industry
• Experience in oncology or oncology immunotherapy clinical trials required
• Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Ability to understand assigned protocol(s) and their requirements
• Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus
• Basic knowledge skills to support program-specific data review and trend identification
• Intermediate medical writing skills and medical terminology
• Basic planning/project management skills (develop short range plans that are realistic and effective)
• Detail-oriented with commitment to quality
• Basic knowledge of disease area, compound, current clinical landscape
$175,000 – $205,000 a year
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.