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.