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Biomarkers Director

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Thursday, September 7, 2023

Job Description

General Summary:

We are seeking a highly motivated scientist to act as a Biomarker Lead, working in a dynamic, cross- functional environment spanning the preclinical, translational and clinical domains to develop a clinical biomarker strategy and implement and deliver biomarkers for Vertex’s clinical assets in Pain.

Key Duties and Responsibilities:

  • Responsible for developing the clinical biomarker strategy for the pain portfolio at Vertex and implementing the biomarker plan during clinical development
  • Collaborate with Research, Translational Medicine and Clinical Development on development of translational biomarker plans for Vertex’s novel NaV programs
  • Collaborate with Clinical Study Teams and colleagues in Translational Medicine and Clinical Development to ensure appropriate inclusion of Biomarkers in clinical studies, including study design
  • Coordinate with Clinical Pharmacology, Biostatistics and Modeling & Simulation to support PK/PD analyses
  • Serve as a key member of project teams, providing expert input and guiding clinical development of novel biomarkers
  • Manage work with CRO and/or collaborate with colleagues from Biomarker Labs to ensure fit-for-purpose validation of clinical biomarker assays prior to implementation
  • Partner with colleagues across the clinical and research organizations to foster an end-to-end view of drug development, always focusing on improving patient care
  • Identify and lead opportunities for biomarker-focused external collaboration

Knowledge and Skills:

  • Demonstrated experience with design, execution and analysis of clinical biomarkers of target engagement, safety, pharmacodynamics, and efficacy in neurology with experience in developing pain biomarkers desired
  • Innovative and able to think creatively with a strong drive toward decision making
  • Effective at building alliances across functions, based on end-to-end drug development experience
  • Excellent interpersonal and communication skills, able to drive global collaborations across a matrixed organization

Education and Experience:

  • A PhD and/or MD with clinical biomarker development experience
  • 9 years post-degree industry experience in the development and execution of Clinical Biomarker strategies with expertise in developing biomarkers for acute and chronic pain related programs.
  • Scientific expertise in electrophysiology or pain research

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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.