Senior Director of Bioanalytics

Pinnacle Medicines; Doylestown (Bucks County); On-site; USD 150,000 - 180,000; Full time

Job summary

A leading biopharmaceutical company is seeking a highly experienced Senior Director of Bioanalytics to lead bioanalytical strategy and execution across its peptide discovery and development programs. Responsibilities include overseeing bioanalytical platforms to support pharmacokinetics and toxicology studies, while managing teams and external partners. A PhD in a relevant field and significant industry experience are required. This position reports to the Head of Translational Science and emphasizes collaboration and regulatory compliance.

Qualifications

• Minimum 8 years of relevant industry experience in bioanalytical sciences.
• At least 3 years of leadership experience managing teams and vendors.
• Expertise in assay development for peptides or biologics.

Responsibilities

• Lead bioanalytical strategy across discovery and clinical development.
• Design, develop, validate, and oversee bioanalytical assays.
• Manage bioanalytical budgets and vendor selection.

Skills

Leadership

Analytical Chemistry

Regulatory compliance

Assay Development

LC-MS/MS

Education

PhD in Analytical Chemistry, Bioanalytical Sciences, Pharmaceutical Sciences or related discipline

Tools

LC-MS/MS

Ligand binding assays

Job description

We are seeking a highly experienced Senior Director of Bioanalytics to lead bioanalytical strategy and execution across Pinnacle’s peptide discovery and development programs. This role will be responsible for establishing and overseeing bioanalytical platforms to support pharmacokinetics, toxicology, and translational studies from discovery through clinical development. The candidate will play a critical role in assay development, method validation, and regulatory-compliant bioanalysis to enable robust PK/PD characterization and regulatory submissions. The position will be reporting to the Head of Translational Science.

Responsibilities

• Lead bioanalytical strategy across discovery, nonclinical, and clinical development programs.
• Design, develop, validate, and oversee bioanalytical assays (LC-MS/MS, ligand binding assays, hybrid assays) for peptides and related modalities.
• Provide scientific leadership for assay sensitivity, selectivity, and robustness appropriate for macrocyclic peptide characterization.
• Collaborate with DMPK and Toxicology to ensure integrated PK, exposure, and biomarker strategies.
• Oversee external CRO bioanalytical partners and ensure GLP/GCP compliance where applicable.
• Contribute to regulatory filings including IND and CTA submissions, author bioanalytical sections, and respond to agency inquiries.
• Establish internal standards and best practices for assay development, validation, and documentation.
• Manage bioanalytical budgets and vendor selection.
• Stay current with emerging technologies in peptide bioanalysis and implement innovative methodologies where appropriate.

Qualifications

• PhD in Analytical Chemistry, Bioanalytical Sciences, Pharmaceutical Sciences, or related discipline with a minimum of 8 years of relevant industry experience.
• At least 3 years of leadership experience managing teams and external vendors.
• Demonstrated expertise in LC-MS/MS and ligand-binding assay development for peptides or biologics.
• Strong understanding of regulatory guidance for bioanalytical method validation (FDA, EMA).
• Experience supporting IND-enabling and early clinical programs.

Preferred Skills

• Experience with macrocyclic peptides.
• Experience integrating bioanalytical data into PK/PD modeling frameworks.
• Familiarity with immunogenicity assessment strategies.