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Associate Director/Director, Bioanalytic Development & Operations (Waltham, MA)
Responsibilities (Including, but not limited to):
- Lead and oversee the development, validation and application of bioanalytical techniques (LC-MS, ELISA, MSD, PCR, cell-based assays) to support PK, PD, biomarker and immunogenicity objectives in non-clinical and clinical studies
- Serve as the departments subject matter expert and be a team resource for bioanalytical knowledge, strategy and application in drug development
- Leverage depth of knowledge and hands-on experience with bioanalytical techniques to advise on assay design, method validation design, and interpretation of method performance data.
- Coordinate and supervise studies conducted at CROs including generation of proposals and SOWs, data generation and analysis, and troubleshooting.
- Author and review bioanalytical reports or summary sections for preclinical/non-clinical/clinical reports, and regulatory documents for initiation of clinical studies (such as IND and CTA) and drug approvals (such as NDA and MAA)
- Prepare, track, and maintain all necessary regents and documentation associated with bioanalytical assays
- Oversee and coordinate collection, processing, storage, and reconciliation of clinical trial samples
- Manage, monitor and document sample transfer between clinical sites, central labs, and testing labs.
- Collaborate with discovery, non-clinical and clinical teams to generate reagents and develop assays to meet project timelines.
- Stay abreast of literature, government guidelines, and internal guidance as relates to the development and use of bioanalytical methods
- Requires a BS in biological field and a minimum of 10 years’ relevant biotechnology industry experience; or an MS degree with a minimum of 8 years’ experience; or a PhD and a minimum of 5 years’ of experience
- Experience with development and qualification of PK/PD and immunogenicity assays in ELISA, MSD and other formats in both human and animal matrices
- Deep scientific and technical experience with and understanding of therapeutic antibody non-clinical and clinical development
- Excellent time management skills and the ability to work with a sense of urgency in a highly collaborative team environment
- Strong oral and written communication including the ability to present information clearly and logically
- Ability to prioritize and manage multiple projects to meet critical deadlines
- Strong attention to detail and problem-solving skills
- Works effectively in a team environment
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- The salary range for this position is commensurate with experience