Sr. Director/ Director of Bioanalysis and Biotransformation

City Therapeutics•Cambridge, MA

2d•$216,000 - $286,000•Onsite

About The Position

We are seeking a highly accomplished leader to serve as Senior Director / Director of Bioanalysis and Biotransformation. This role will provide strategic direction and hands-on leadership for bioanalytical and biotransformation functions supporting both nonclinical and clinical drug development programs. The successful candidate will lead the design, development, and execution of bioanalysis, pharmacokinetics/toxicokinetic (PK/TK), drug metabolism, and biomarker assay strategies across discovery and development. This individual will ensure scientific excellence, regulatory compliance, and operational efficiency while partnering closely with cross-functional teams to advance programs toward key milestones.

Requirements

Ph.D. or equivalent degree in Biochemistry, Pharmacology, Analytical Chemistry, or related scientific discipline.
10+ years of industry experience in bioanalysis, with demonstrated impact across nonclinical and clinical drug development programs.
Deep expertise in pharmacokinetic (PK), pharmacodynamic (PD), and biomarker assay development to support nonclinical and clinical studies, with a strong focus on clinical, translational, and precision biomarker applications.
Proven ability to bridge nonclinical and clinical biomarker strategies, including fit-for-purpose assay validation, assay transfer, and integration of bioanalytical data to inform dose selection, safety, and efficacy decisions.
Established people and matrix leadership experience, including managing internal teams and external CROs, and partnering effectively with cross-functional stakeholders.
Strong working knowledge of GLP/GCP and global regulatory expectations, with direct experience supporting IND/CTA-enabling studies, clinical trials, and inspection-ready bioanalytical data packages.
Experience supporting novel therapeutic modalities (e.g., oligonucleotides, biologics) and authoring or reviewing bioanalytical and biomarker sections of regulatory submissions.
Excellent written and verbal communication skills, with the ability to clearly present complex nonclinical and clinical bioanalytical and biomarker data to project teams and senior leadership.
Demonstrated ability to operate effectively in a fast-paced, resource-conscious environment, with a strong focus on data quality, compliance, and timely delivery.

Nice To Haves

Working knowledge of, and/or hands-on experience in drug metabolism across discovery and development stages is a plus.

Responsibilities

Provide scientific, technical, and strategic leadership for bioanalysis and biotransformation in support of discovery, nonclinical and clinical development programs.
Oversee the design, development, qualification, validation, and execution of bioanalytical, PK/TK, and biomarker assays in compliance with GLP/GCP standards and global regulatory expectations.
Lead the interpretation and integration of bioanalytical and biotransformation data to inform pharmacokinetics, exposure–response, and human dose projections.
Manage and mentor internal teams and oversee external CROs, ensuring high-quality execution, adherence to timelines, and budget accountability
Ensure data integrity, high-quality documentation, and inspection of readiness for regulatory submissions, audits, and health authority inspections.
Partner closely with cross-functional teams—including DMPK, Toxicology, Clinical Development, and Biology—to align bioanalytical strategies with program objectives and development milestones.
Contribute to regulatory filings (e.g., IND, CTA, NDA/BLA) and support responses to health authority inquiries related to bioanalysis and biotransformation.
Present scientific strategies, results, and data interpretation to cross-functional teams, senior leadership, and external stakeholders.
Drive continuous improvement and innovation in assay platforms, analytical technologies, and operational processes.