Overview
Director (Bioanalytical)
Greater Boston (onsite)
Our client is looking for an established individual in the bioanalytical pharmacology industry wanting to make a difference at a small therapeutics company. The Director will be responsible for managing various CROs to lead clinical and preclinical drug development programs.
Primary Responsibilities
- Bioanalytical assay representative for biologics discovery and clinical development project team
- Manage various CROs by identifying, evaluating and implementing novel technologies to address challenges in drug development
- Apply experience and deep knowledge of bioanalytical methods including potency assays, ADA assays, and methods for immunogenicity testing, interpretation of PK/PD
- Spearhead bioanalytical/immunogenicity aspects of clinical trials, work closely with clinical colleagues, and contribute to clinical study reports
Candidate Qualifications
- Requires a Ph.D. and 10+ years preferred post-Ph.D. of experience within preclinical and clinical biologics
- Extensive experience with biologics PK/PD, bioanalysis, and immunogenicity
- Demonstrated experience in working with CROs and managing multiple projects.
- Understanding of regulatory requirements and current industry practices in the areas of bioanalytical validation and testing
Salary:
- $200-220K + 20% bonus + RSUs (4 years vesting)
- 401K + 3% match dollar for dollar and then 50% match up to another 2%
- Health and Dental Insurance