DMPK Senior Research Fellow Biotherapeutics

Job Description

General Summary:

We are seeking an accomplished and strategic leader to serve as Senior Research Fellow DMPK Project Lead to guide the DMPK strategy for our Biotherapeutics portfolio including protein antibody ADC and cell and genetic therepies. The responsibilities will span from early research through clinical development. This leader will play a central role in ensuring that PK bioanalysis ADME and translational PKPD insights are fully integrated into program decision-making and development plans.

The ideal candidate will bring deep strategic and technical expertise in DMPK for one or more biotherapeutic modalities described above have demonstrated leadership in a matrixed environment and have the ability to influence cross-functional teams and governance bodies at Vertex

Key Responsibilities

• Serve as the DMPK Lead and/or supervise other DMPK leads for biotherapeutics programs develop and execute DMPK scientific strategies from discovery through clinical development.
• Build and maintain strong collaborative partnerships with Biology Preclinical Safety Clinical Pharmacology CMC and other R & D disciplines to align DMPK strategy with overall program goals and advance Vertex programs through discovery and development.

• Represent DMPK function on drug discovery and development teams and with Vertex R & D governance bodies driving data-informed decisions related to PK immunogenicity disposition metabolism and biotransformation of biotherapeutics.

• Provide scientific and managerial leadership to the team in prioritizing and executing on key deliverables and project needs.

• Oversee design execution and interpretation of PK ADME and bioanalytical/immunogenicity assays for biotherapeutics and guide translational PKPD approaches to support dose selection and clinical projections.

• Provide clear communication on DMPK findings implications and recommendations to team members and senior leadership.

• Ensure scientific excellence and regulatory compliance in all necessary DMPK regulatory documents and reports to support drug development including investigator brochures INDs (or equivalent) and marketing applications.

• Help shape long-term DMPK strategy capabilities and best practices for biotherapeutics across the organization.

• Participate in review of business development opportunities

Qualifications

• PhD in Pharmacokinetics Pharmaceutical Sciences Biochemistry Biology or related field with 15 years of industry experience
• Successful track record and experience in a DMPK lead role on multiple R&D teams across more than one therapeutic area. Extensive experience working with one or more biotherapeutic modalities (e.g. protein antibody and nucleic acid therapeutics cell and gene therapies) is a must.
• Deep scientific and strategic expertise in various components of DMPK science such as PK ADME bioanalysis immunogenicity biotransformation and translational PKPD modeling approaches for biologics.
• Excellent communication skills and ability to develop and grow strong cross-site/function collaborations.
• Experience preparing regulatory submissions and interacting with health authorities.
• Strong management and leadership skills with emphasis on developing and mentoring junior DMPK project leads

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: 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-Hybrid

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