​Director of Clinical Biomarkers - Diagnostics-Massachusetts-Remote

A leading commercial pharmaceutical company is looking for a Director of Clinical Biomarkers for their clinical diagnostic portfolio (CDx). They are revolutionizing the cell/gene therapy space with one of their assets entering phase III; you will be responsible for leading the bioanalytical team for their rare disease portfolio.

Key Responsibilities:

• Develop and implement the bioanalytical strategy for clinical trials and CDx development.

• Provide leadership in bioanalytical assay development, validation, and execution.

• Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, and Biomarker Discovery to integrate bioanalytical data into clinical decision-making processes.

• Oversee the design, development, validation, and implementation of bioanalytical assays (e.g., ligand binding assays, mass spectrometry-based assays) to support clinical trials.

• Manage internal and external bioanalytical laboratories, ensuring high quality and timely delivery of bioanalytical data.

• Ensure that bioanalytical activities comply with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and regulatory guidelines.

• Lead the preparation of bioanalytical sections of regulatory submissions (IND, BLA, NDA).

• Ensure compliance with relevant regulatory requirements and guidelines (FDA, EMA, etc.).

• Support clinical pharmacology and pharmacokinetic modeling efforts by providing high-quality bioanalytical data.

Qualifications:

• PhD in related field with 8+ years of experience with analytical techniques for cell/gene therapy products for clinical products.

• Experience with CDx.