Associate Director​/Director, Bioanalytic Development & Operations; Waltham, MA

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 department’s 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 reagents 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 a 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’ 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