DMPK and Bioanalytical Associate Director

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 highquality 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 DMPKBA 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 highquality data that directly informs development translational and regulatory decisionmaking 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 phaseappropriate 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 largemolecule therapeutics including ligand binding and cell-based PK immunogenicity and biomarker assays
• Strong understanding of phaseappropriate assay qualification and validation and method transfer to external laboratories
• Demonstrated ability to provide scientific and technical leadership on complex highvalue 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 crossfunctional and external partnerships
• Prior participation in regulatory inspections audits or health authority interactions preferred

Education and Experience:

• Bachelors Masters or PhD in Analytical Chemistry Biochemistry Protein Sciences Chemistry or a related scientific discipline
• Bachelors degree (or equivalent degree) and 11 years of productive relevant employment experience or
• Masters 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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at