DMPK and Bioanalytical Associate Director

Vertex Inc.•Seattle, WA

1d•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

Prior participation in regulatory inspections, audits, or health authority interactions preferred

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