Associate Director, Clinical Biomarkers Lead
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 to the Sr. Director of Clinical Biomarkers.
- Responsible for developing the clinical biomarker strategy for programs and implementing it as projects near the clinic.
- Provide input as Biomarker plans are developed by the Translational Biomarker Lead.
- Collaborate with Clinical Study Teams and clinical colleagues to ensure appropriate inclusion of Clinical Biomarkers in clinical studies, including study design.
- Align with Research to ensure appropriate interpretation of biomarker readouts.
- Coordinate with Clinical Pharmacology and Modelling & Simulations to support utilization of quantitative pharmacological approaches during development.
- Work with Project Management to ensure Companion Diagnostics development 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 biomarkers through the Development phases.
- Manage work with CRO and/or collaborate with colleagues from Research to ensure fit-for-purpose validation of clinical biomarker assays complete 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. As well as, with Translational Biomarker and Clinical Development leads identifying opportunities for biomarker-focused external collaboration and lead collaborations
- Demonstrated experience with design, execution and analysis of clinical biomarkers readouts of target engagement, PD response, etc
- Innovative and have the ability to think creatively with a strong drive for decision making.
- Effective at building alliances across functions, based on end-to-end drug development thinking and experience.
- Excellent interpersonal and communication skills, able to drive global collaborations across a matrix organization.
- Preferably a PhD and/or MD with development experience (at least 7+ years post-degree experience in Clinical Biomarkers).
- 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, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. 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.