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.
Bolt Biotherapeutics has an exciting opportunity for an experienced and highly motivated Clinical Scientist to join our Clinical Development team and play a key role in assessing and reviewing translational data from early and late phase developments for immunology-focused oncology clinical trials. Strong candidates will be self-motivated, scientifically curious, and collaborative, with a proven track record to provide scientific expertise necessary to design and deliver on translational clinical studies and programs. This position will report directly to VP, Clinical Development and will be a key contributor in developing clinical research documents, including clinical study synopses, protocols, CRFs, informed consent templates, clinical study reports, feasibility assessments, and site selection strategies. This work is to be accomplished in collaboration with Medical Leads, Clinical Operations, Regulatory and study statisticians, and encompasses clinical study synopses, protocols, CRFs, informed consent templates, clinical study reports, feasibility assessments, and site selection strategies as deliverables.
• Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g., mechanism of action, animal models), translational and clinical data relevant to programs
• Engage opinion leader interactions to build pipeline awareness and foster research collaborations
• Write, edit, and review medical and scientific elements of clinical research, operational, and regulatory documents to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency. This may include primary ownership of documents such as clinical trial protocol, synopsis, and associated amendments
• Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies
• Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents, and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents
• Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents
• Share scientific knowledge with the organization during continuing education sessions and CRA and vendor training, at an adapted level of understanding
• Excellent competency in the data review of oncology translational clinical study data; skill in aggregate data review, interpretation, and trend detection. Knowledge of multiple tumor evaluation criteria and their application to drug development
• Bachelor's Degree, MD, PhD, Pharm D, or nurse; would consider a master’s person with 8 years of industry experience in clinical research, including protocol design and execution
• Specific expertise and experience in oncology trials preferred
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols
• A solid understanding of response evaluation criteria in solid tumors (RECIST)
• Strong project management experience
• Excellent interpersonal communication, collaboration, organization, and presentation skills with the ability to understand, influence, collaborate, negotiate and lead in a diverse team based
• Proficiency in Power Point
• Experience with GCP and ICH guidelines
• Ability to produce high quality work in a small company environment
• Ability to travel up to 20% required
$125,000 - $190,000 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.