Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.voyagertherapeutics.com.
Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc.
Job Summary
Voyager Therapeutics is seeking an experienced Head of Translational Medicine to join our growing Development team. The ideal candidate will drive strategy and oversight of assay development of translational biomarker approaches that measure targets for both fluid and imaging biomarkers for our Neurogenetic programs. As a strategic leader the Head of Translational Medicine will ensure that Voyager’s biomarker strategies align with the most current understanding of novel biomarker technologies in the CNS space. This role is a unique opportunity to work at the interface of discovery and development while championing biomarker-initiatives that have a direct impact on novel clinical study design. This position will report to Voyager’s Chief Medical Officer and is a hybrid position with minimum of 3 days onsite in our Lexington office.
Key Responsibilities
Lead efforts to develop and implement translational biomarker strategies that assess proof of mechanism, establish early signs of efficacy and enable proof of concept studies
Drive collaboration with research scientists to ensure the integration of biomarker discoveries into the design of early clinical studies
Oversee clinical validation of biomarker assays and collaborate with internal and external teams in the analysis of clinical biomarker studies
Provide oversight of assay development and validation activities of CROs from a technical, budget and timeline perspective.
Contribute to authoring/review of clinical study protocols, investigator brochures and additional documents as needed.
Partner with development leaders on identification of validated surrogate endpoints/biomarkers for clinical trial enrollment and accelerated registrational approvals
Lead the analysis of biomarker results to inform future decision making
Qualifications
PhD or equivalent in life sciences, chemistry, engineering, or related discipline
Minimum 12 years of experience in the pharmaceutical or biotechnology industry with a focus on biomarker sciences, minimum of 3 with a neurological focus
Ability to drive and influence projects from discovery through early clinical development with a focus on the development of biomarker strategies that enable early proof-of-concept and inform the clinical strategy for rare and neurodegenerative diseases
Outstanding analytical, research and organizational skills
Ability to drive and influence projects from discovery through early clinical development with a focus on the identification of indications and development of biomarker strategies that enable early proof-of-concept
Experience in the identification and validation of pharmacodynamic and disease biomarkers, as well as their clinical implementation
Prior management of contract research organizations (CROs) for clinical biomarker assay development and qualification.
Strong biomarker data analysis experience including experience working with Biostatisticians, Programmers, Bioinformaticians and data visualization software is strongly preferred
Experience with cell or gene therapy a plus
Experience with fluid biomarkers
Familiarity with regulatory guidelines for accelerated pathways
Demonstrated ability in problem solving, quantitative and critical thinking
Ability to handle multiple projects, meet deadlines and make decisions
Proficient project management, presentation and communication skills
Prior experience implementing precision medicine approaches in clinical trials including companion diagnostic (CDx) development experience in liquid-based tissue-based approaches.
Seniority level
Executive
Employment type
Full-time
Job function
Health Care Provider
Industries
Biotechnology Research
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