City Therapeutics · 17 hours ago
Sr. Director/ Director of Bioanalysis and Biotransformation
Cambridge, MA
Full-time
Onsite
Director/Executive
$216K/yr - $286K/yr
10+ years expCity Therapeutics is 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, ensuring scientific excellence and regulatory compliance while partnering with cross-functional teams.
BiopharmaLife ScienceTherapeutics
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
Qualification
Required
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
Preferred
Working knowledge of, and/or hands-on experience in drug metabolism across discovery and development stages is a plus
Benefits
Annual cash bonus
Equity compensation
Medical
Dental
Vision
Life insurance
Health and dependent care FSA accounts
HSA/HRA accounts with company contributions
401(k) with competitive company match
Company
City Therapeutics
City Therapeutics is a biopharmaceutical company focused on developing next-generation small interfering RNAs.
11-50 employees
H1B Sponsorship
City Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (2)
Funding
Current Stage
Early StageTotal Funding
$135MKey Investors
ARCH Venture Partners
2024-10-08Series A· $135M
Leadership Team
Sebastian Trousil
Co-Founder and Chief Operating Officer
Recent News
Company data provided by crunchbase