Associate Director, Clinical Scientist

Location
Redwood City, CA
Posted
Jan 18, 2022
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

Associate Director, Clinical Scientist

The Position:
Reporting directly to the SVP, Clinical Development & Translational Medicine the candidate with serve as the primary source of clinical oversight of one or more early phase clinical trials.

Key Responsibilities:
Will be responsible for the execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
Support trial level activities for one or more trials with the necessary supervision
Co-lead study team meetings in partnership with protocol manager and collaborate with cross-functional study team members
Review clinical narratives
Monitor clinical data for specific trends
Develop 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
Submit 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.)


Job Requirements:
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)
Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Ability to understand assigned protocol(s) and their requirements
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


Who We Are:
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbodyâ„¢ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics that have eliminated tumors following systemic administration in preclinical studies while also developing immunological memory, which may lead to more durable clinical responses for patients. This is a unique opportunity to join and build, with like- minded colleagues, a company that will transform the lives of individuals with cancers. We are an Equal Opportunity Employer offering a competitive salary and benefits package.