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, 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:

$166,500 - $249,700

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

On-Site Designated 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. #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 person's 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 ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.

Our vision is clear:

to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.