Executive Director, Bioanalytical Development

Role Summary

The Executive Director, Head of Bioanalytical Development leads bioanalytical capabilities to develop, validate, and implement robust PK and immunogenicity assays for accelerated transition from discovery through IND, late-stage development, and licensure. Responsible for ligand binding, mass spectrometry, and molecular assay development of PK and ADA, and for selecting strategic partner labs for toxicology studies and clinical trials in line with regulatory expectations. Reports to the Head of Translational Biomarkers and collaborates across research, clinical teams, and vendor oversight to support preclinical studies and clinical trials. This role is based in Waltham, MA, with relocation to the area required.

Responsibilities

• Lead and evolve the Bioanalytical Development function, overseeing assay development, validation, and implementation for PK and immunogenicity endpoints.
• Develop and execute strategic plans aligned with pipeline priorities, ensuring timely and high-quality data delivery.
• Build and mentor a high-performing team with diverse technical expertise and an innovative mindset.
• Serve as the primary scientific interface with CROs and external partners, ensuring alignment on quality, timelines, and regulatory compliance.
• Collaborate cross-functionally with Clinical Pharmacology, Preclinical Development, Regulatory Affairs, Quality Assurance, and Therapeutic Area leads to support integrated development strategies.
• Ensure compliance with global regulatory standards (FDA, EMA, ICH, GCP, GLP) and contribute to regulatory filings (IND, BLA, MAA).
• Champion the adoption of cutting-edge technologies and methodologies in bioanalysis, including ligand-binding assays, LC-MS/MS, and cell-based assays.
• Drive continuous improvement initiatives and implement best practices in bioanalytical operations and data integrity.

Qualifications

• Ph.D. or equivalent in Biochemistry, Pharmacology, or related field with 12+ years of experience in bioanalytical sciences within the biopharmaceutical industry.
• Proven leadership experience managing large, multidisciplinary teams and external partnerships.
• Deep expertise in bioanalytical assay development for biologics and small molecules, including PK, ADA, and biomarker assays.
• Strong understanding of regulatory requirements and experience supporting global regulatory submissions.
• Demonstrated ability to influence cross-functional teams and drive strategic initiatives.
• Excellent communication, organizational, problem-solving and project management skills.
• Experience with overseeing vendors.
• Experience in a fast-paced biotech environment.
• Track record of innovation and scientific contributions in bioanalysis.