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.
The Position
Reporting to the Chief Medical Officer, the position will define and oversee the Translational Medicine strategy for several drug program across multiple indications. He or she will play a key leadership role at Bolt by providing strategic and scientific leadership to ensure appropriate translational, biomarker and bioanalytical strategies are established and implemented in an efficient and integrated fashion. This individual will partner with therapeutic areas in Basic Research and Clinical Development, serving as a bridge between Research and Development. The successful candidate will set goals and enumerate key scientific questions that will drive clinical development decision-making. In doing so, he or she will align closely with the product team and internal and external stakeholders. Other responsibilities will include but not be limited to identifying and interacting with key external experts and monitoring progress toward the goals of external research programs. Lastly, he or she will be responsible for constructing translational plan documents, biomarker statistical analysis plans in collaboration with persons in the Biometrics Team and contribute to the construction of clinical translational development plans, clinical translational protocols, the preparation/submission of relevant regulatory documents, as well as supporting Bolt's developing strategy including patient selection for trials and commercialization.
Key Responsibilities
Individual contributor, but with capabilities (expertise and leadership) to manage scientists and associate director(s) as the translational programs grow
Develop and maintain a translational plan for several programs across all indications.
Define key translational scientific questions and steps taken to answer them
Identify and interact with key external experts, defining scientific questions to be answered. Monitor progress toward goals of external collaboration programs
Construct translational plan documents and draft biomarker statistical analysis plans, aid in the construction of clinical translational development plans, clinical translational protocols, and the submission of relevant regulatory documents. Support Bolt's strategy to optimize patient selection strategy for research and commercialization
Lead the Translational Sub-team within the Project Team for relevant drug programs. Present as needed at internal and external meetings
Serve as reviewer of reports, technical documents and presentations to support IND/CTA/BLA/MAA
Support analysis, interpretation, and reports for internal decision-making and Health Authority submissions
Job Requirements
12+ years of progressive experience in a science-based organization leading significant Oncology biomarker and diagnostic efforts
Strong background in cancer biology and immunology is preferred
PhD, or equivalent preferred
MD or equivalent preferred
Demonstrated ability and expertise as a translational and scientific medical expert in a complex matrix environment
Demonstrated scientific and business acumen and the ability to influence senior leaders and stakeholders and lead complex partnership and alliance activities
Understand translational immunology, cytokines, chemokines, and biomarker testing (protein and gene)
Excellent interpersonal, presentation, verbal, and written communication skills
Strong organization and time management skills
Willingness and ability to travel nationally and globally (<25%)
Knowledge and understanding of early and late-phase clinical trial design and global regulatory requirements for study execution
Demonstrated ability to represent the Company in a variety of internal and external settings
Ability to develop and maintain relationships with significant key opinion leaders and thought leaders
Experience managing physicians and/or scientific staff in a management or team leader capacity is highly desirable
Exceptional interpersonal, influencing, presentation, and written and verbal communication skills
$240,000 - $280,000 a year