Associate Director / Director, Clinical Biomarkers

We are seeking a highly motivated scientist to act as a Clinical Biomarker Lead, working in a dynamic, cross- functional environment within the clinical development team to implement biomarker strategies for Vertex clinical assets. This position will report directly to the Head of Clinical Biomarkers.

Key Responsibilities: 
 

• Responsible for developing the clinical biomarker strategy for programs and implementing the biomarker plan during clinical development.
• Collaborate with Research and Translational Medicine on development of translational biomarker plans.
• Collaborate with Clinical Study Teams and colleagues in Translational Medicine and Clinical Development to ensure appropriate inclusion of Clinical Biomarkers in clinical studies, including study design.
• Coordinate with Clinical Pharmacology, Biostatistics and Modeling & Simulation to support quantitative pharmacological approaches during clinical development.
• Work with Project Management to ensure the development of Companion Diagnostics in parallel to drug development as appropriate.
• Serve as a key member of project teams, providing expert input to teams 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
• Minimum Qualifications

   

  Minimum Qualifications:
   

   

• Demonstrated experience with design, execution and analysis of clinical biomarkers of target engagement, safety, pharmacodynamics, and efficacy.
• 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.

Preferred Qualifications:
 

• A PhD and/or MD with clinical biomarker development experience (at least 7+ years post-degree industry experience in the development and execution of Clinical Biomarker strategies).
• Experience in Neuroscience and Pain therapeutic area is desirable but not required.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. 

Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston's Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 2,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. 

Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards. For additional information and the latest updates from the Company, please visit www.vrtx.com. 

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.