DMPK and Bioanalytical Associate Director
Vertex Pharmaceuticals
June 27, 2026
On-site
Seattle, WA
Clinical Research and Development
General Summary:
The Associate Director, DMPK and Bioanalysis drives DMPK-related activities across multiple biotherapeutic programs. Serves as an emerging leader in one or more DMPK disciplines and provides technical expertise in bioanalytical assay development, validation, and CRO management. Delivers reliable, high-quality DMPK and bioanalytical data in support of Research and Development programs.
Key Duties And Responsibilities:
- Act as DMPK and Bioanalytical Lead on multidisciplinary project teams; communicate data, risk assessments, and recommendations to stakeholders.
- Shape and deliver PK and bioanalytical strategies across a biotherapeutic portfolio, informing development, translational, and regulatory decisions from preclinical through clinical stages.
- Contribute to design, execution, interpretation, and reporting of in vivo PK and PK/PD studies.
- Plan, implement, and manage bioanalytical testing activities for preclinical, clinical, and pharmacology studies.
- Contribute to bioanalytical method development; qualify/validate assays (ligand binding, cell-based PK, immunogenicity, biomarkers); oversee transfer to CROs.
- Contribute to CRO evaluation/selection/management (vendor audits, troubleshooting, external collaborations).
- Prepare regulatory data packages, dossiers, and responses for health authority interactions, audits, and inspections.
- Review and influence changes to systems, procedures, methods, and regulatory submissions for continuous improvement.
Knowledge And Skills (Required/Preferred):
- Deep expertise integrating in vitro/in vivo data for compound progression and risk assessment.
- Pharmacokinetics knowledge and experience with software (e.g., Phoenix WinNonlin).
- Expertise in bioanalytical assay development for large-molecule therapeutics (ligand binding, cell-based PK, immunogenicity, biomarkers).
- Phase-appropriate assay qualification/validation and method transfer.
- Leadership on complex, high-value projects.
- CRO experience in regulated environments; oversight of data quality and compliance with GLP/GxP and regulatory standards.
- Quality systems and regulatory requirements knowledge (GLP/GxP, 21 CFR Part 11/210/211).
- Ability to mentor others; strong written/verbal communication.
- Initiative and collaboration; prior regulatory inspections/audits/health authority interactions preferred.
Education And Experience:
- BS/MS/PhD in Analytical Chemistry, Biochemistry, Protein Sciences, Chemistry, or related field.
- BS + 11+ years; MS + 9+ years; or PhD + 6–8+ years post-doctoral experience.
Pay Range:
- $166,500 - $249,700
Flex/On-site:
- On-site designated; five days per week on-site with ad hoc flexibility.
Application Instructions:
- Contact Talent Acquisition at ApplicationAssistance@vrtx.com for accommodation requests related to the hiring process or performing essential functions.
The Associate Director, DMPK and Bioanalysis drives DMPK-related activities across multiple biotherapeutic programs. Serves as an emerging leader in one or more DMPK disciplines and provides technical expertise in bioanalytical assay development, validation, and CRO management. Delivers reliable, high-quality DMPK and bioanalytical data in support of Research and Development programs.
Key Duties And Responsibilities:
- Act as DMPK and Bioanalytical Lead on multidisciplinary project teams; communicate data, risk assessments, and recommendations to stakeholders.
- Shape and deliver PK and bioanalytical strategies across a biotherapeutic portfolio, informing development, translational, and regulatory decisions from preclinical through clinical stages.
- Contribute to design, execution, interpretation, and reporting of in vivo PK and PK/PD studies.
- Plan, implement, and manage bioanalytical testing activities for preclinical, clinical, and pharmacology studies.
- Contribute to bioanalytical method development; qualify/validate assays (ligand binding, cell-based PK, immunogenicity, biomarkers); oversee transfer to CROs.
- Contribute to CRO evaluation/selection/management (vendor audits, troubleshooting, external collaborations).
- Prepare regulatory data packages, dossiers, and responses for health authority interactions, audits, and inspections.
- Review and influence changes to systems, procedures, methods, and regulatory submissions for continuous improvement.
Knowledge And Skills (Required/Preferred):
- Deep expertise integrating in vitro/in vivo data for compound progression and risk assessment.
- Pharmacokinetics knowledge and experience with software (e.g., Phoenix WinNonlin).
- Expertise in bioanalytical assay development for large-molecule therapeutics (ligand binding, cell-based PK, immunogenicity, biomarkers).
- Phase-appropriate assay qualification/validation and method transfer.
- Leadership on complex, high-value projects.
- CRO experience in regulated environments; oversight of data quality and compliance with GLP/GxP and regulatory standards.
- Quality systems and regulatory requirements knowledge (GLP/GxP, 21 CFR Part 11/210/211).
- Ability to mentor others; strong written/verbal communication.
- Initiative and collaboration; prior regulatory inspections/audits/health authority interactions preferred.
Education And Experience:
- BS/MS/PhD in Analytical Chemistry, Biochemistry, Protein Sciences, Chemistry, or related field.
- BS + 11+ years; MS + 9+ years; or PhD + 6–8+ years post-doctoral experience.
Pay Range:
- $166,500 - $249,700
Flex/On-site:
- On-site designated; five days per week on-site with ad hoc flexibility.
Application Instructions:
- Contact Talent Acquisition at ApplicationAssistance@vrtx.com for accommodation requests related to the hiring process or performing essential functions.