Associate Director, Translational Research
Department : Drug Development
Employment Type : Full Time
Location : San Mateo, CA
Description
The Role :
We are seeking an experienced and motivated Associate Director, Translational Research to join our drug development team, focusing on early-stage clinical development of biologic drugs in oncology and inflammatory diseases. This role will be pivotal in bridging preclinical research and clinical development by driving translational strategies, establishing and implementing translational and diagnostic development plans, setting up clinical sample management systems, and establishing bioassays in partnership with Contract Research Organizations (CROs). This individual will play a key role in developing, implementing, and managing critical laboratory and clinical functions that enable the evaluation of novel biologics.
Key Responsibilities
Key Responsibilities
Translational, Biomarker and Diagnostic Strategy :
- Develop and execute translational strategies to bridge preclinical and clinical findings for oncology and inflammatory disease indications.
- Identify and validate biomarkers for patient stratification, efficacy, pharmacodynamics, and safety assessment.
- Assess diagnostic needs and formulate a strategic plan for diagnostic development and implementation.
- Collaborate with Research, Clinical teams, and external KOLs to integrate biomarker data into clinical protocols and contribute to decision-making processes.
- Lead the development, validation, and implementation of anti-drug antibody (ADA) assays to support immunogenicity assessments, ensuring compliance with regulatory guidelines and industry best practices.
Clinical Sample Management :
Design and implement sample management workflows for handling patient samples from Phase 1 clinical trials, including collection, storage, and transfer processes.Develop standard operating procedures (SOPs) for sample handling to ensure high quality, consistency, and compliance with regulatory standards.Coordinate with internal and external stakeholders to ensure timely processing and delivery of clinical samples for analysis.Bioassay Development and Management :
Establish and validate robust bioassays to evaluate ADA, pharmacodynamic, and predictive biomarkers for clinical trial samples.Coordinate with external CROs to develop and optimize assays and ensure they meet program-specific requirements and regulatory guidelines.Oversee bioassay testing at CROs, ensuring high-quality data output, timely delivery, and adherence to project timelines and budget.Data Analysis and Reporting :
Work closely with clinical pharmacology, bioinformatics, and clinical teams to analyze and interpret biomarker data.Prepare and present data and findings to cross-functional teams, BigHat Leadership, and external stakeholders, including regulatory authorities.Contribute to scientific publications, posters, and presentations as part of the company’s knowledge-sharing and publication strategy.Cross-Functional Collaboration :
Partner with clinical operations, regulatory affairs, and quality assurance teams to ensure compliance with regulatory requirements and best practices in clinical research.Serve as the translational science point of contact with CROs, maintaining strong, effective communication and collaboration.Skills Knowledge and Expertise
Qualifications
M.S. or Ph.D. in a relevant field (e.g., Cancer Biology, Molecular Biology, Immunology) with 5 years of industry experience in translational research, preferably within oncology and inflammatory disease indications.Proven expertise in developing biomarker strategies and bioassay development for clinical trials, especially in the context of oncology and / or inflammatory disease indications.Experience with clinical sample management systems and working with CROs to implement bioassay testing.Knowledge of regulatory requirements for clinical biomarker studies, including GCP and CLIA.Strong analytical skills with experience in data interpretation, especially regarding biomarker data and clinical correlations.Excellent organizational, communication, and project management skills.Preferred Qualifications
Familiarity with clinical trial design and early-stage drug development.Experience in oncology, inflammatory disease indications and / or molecular targeted therapies.Knowledge of statistical methods for biomarker analysis and familiarity with relevant bioinformatics tools.Logistics
Location :San Mateo, CA
Hybrid (3 Days per Week Onsite)
Salary Range :175K - $230K
Please note : at BigHat we believe in titles and compensation that are commensurate with skill set, relative organizational impact, and value contribution; more experienced candidates are encouraged to apply, with the understanding that responsibilities, title, and compensation would adjust as appropriate.
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Salary : $175,000 - $230,000
