Job Description

General Summary:

The Associate Director, DMPK and Bioanalysis drives DMPK-related activities across multiple biotherapeutic programs.  This role is recognized internally as an emerging leader in one or more disciplines within DMPK, as well as bringing technical expertise in bioanalytical assay development, validation, and CRO management. The Associate Director demonstrates scientific rigor and accountability, working collaboratively across functions and teams to ensure delivery of reliable, high‑quality DMPK and bioanalytical data in support of Research and Development programs.

Key Duties and Responsibilities:

• Acts as the DMPK and Bioanalytical Lead on multidisciplinary project teams, representing the integrated DMPK‑BA perspective and clearly communicating data, risk assessments, and recommendations to project stakeholders
• Shapes and delivers PK and bioanalytical strategies across a portfolio of biotherapeutic programs, generating high‑quality data that directly informs development, translational, and regulatory decision‑making from preclinical through clinical stages
•  Contributes scientific and strategic input to the design, execution, interpretation, and reporting of in vivo PK and PK/PD studies
• Plans, implements, and manages a broad range of bioanalytical testing activities for biotherapeutic candidates in support of preclinical, clinical and pharmacology studies
• Contributes to bioanalytical method development and phase‑appropriate qualification and validation of assays (including ligand binding and cell-based PK, immunogenicity and biomarker assays), and oversees transfer of methods to CROs
• Contributes to CRO evaluation, selection, and ongoing management, including participation in vendor audits, troubleshooting assay performance, and management of external collaborations
• Contributes to preparation of regulatory data packages, dossiers, and responses in support of interactions with health authorities, audits, and inspections
• Reviews and influences changes to systems, procedures, methods, and regulatory submissions to support continuous improvement across bioanalytical and development functions

Knowledge and Skills:

• Deep expertise in DMPK and bioanalytical science, with demonstrated ability to integrate in vitro and in vivo data to inform compound progression and risk assessment
• Knowledge of basic pharmacokinetics and experience working with common pharmacokinetics software (e.g., Phoenix WinNonlin)
• Specialized depth of knowledge in bioanalytical assay development for large‑molecule therapeutics, including ligand binding and cell-based PK, immunogenicity and biomarker assays
• Strong understanding of phase‑appropriate assay qualification and validation and method transfer to external laboratories
• Demonstrated ability to provide scientific and technical leadership on complex, high‑value project assignments
• Strong experience working with CROs in regulated environments, including oversight of data quality and compliance with GLP/GxP and relevant regulatory standards
• Working knowledge of quality systems and regulatory requirements (e.g., GLP/GxP, 21 CFR Part 11/210/211)
• Ability to mentor and advise others on technically challenging bioanalytical strategies and execution
• Strong written and verbal communication skills, with the ability to author and review advanced technical documents and effectively communicate scientific concepts to diverse audiences
• Demonstrated initiative, persistence, and scientific creativity to advance development programs
• Values teamwork and collaboration within cross‑functional and external partnerships
• Prior participation in regulatory inspections, audits, or health authority interactions preferred

Education and Experience:

• Bachelor’s, Master’s, or PhD in Analytical Chemistry, Biochemistry, Protein Sciences, Chemistry, or a related scientific discipline
• Bachelor's degree (or equivalent degree) and 11+ years of productive, relevant employment experience, or
• Master's degree (or equivalent degree) and 9+ years of productive, relevant employment experience, or
• Ph.D. (or equivalent degree) and 6-8+ years of productive, relevant post-doctoral employment experience

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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