Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging innovative expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. Voyager's TRACER AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. This platform is fueling alliances with Pfizer Inc., Novartis and Neurocrine Biosciences as well as multiple programs in Voyager's own pipeline. Voyager's pipeline includes preclinical programs in Parkinson's disease, Alzheimer's disease, and amyotrophic lateral sclerosis (ALS), each with validated targets and biomarkers to enable a path to rapid potential proof-of-biology. For more information, visit www.voyagertherapeutics.com.
Voyager Therapeutics is seeking an experienced Vice President of Toxicology to join our growing organization. The Vice President will lead all nonclinical safety strategies to advance our exciting programs including designing and conducting investigative non-GLP and GLP compliant small and large animal toxicology studies across our platform. As project toxicologist, you will partner with our internal teams to design investigative programs to address toxicology findings and deliver a balanced assessment of the risk/ benefit profile associated with a drug candidate. You will play a key role fostering strong relationships with our program teams and external CRO partners as well as, partner closely with regulatory in preparing submissions.
- Provide strategic planning and execution of non-clinical toxicology package to support candidate selection and progression or inform no-go decisions.
- Design investigative programs to address toxicology findings/issues/circumstances to determine human relevance.
- Develop preclinical data packages for both non-GLP and GLP toxicology studies to support project advancement to and through clinical development.
- Coordinating non-GLP and GLP preclinical in vivo studies conducted in both rodent and large animal models, including NHP.
- Communicate scientific data internally and externally, author/ review study reports and regulatory documentation, contribute to high impact scientific manuscripts, identify and manage external research collaborations, and engage with scientific advisors and consultants.
- Lead efforts for vendor qualification, study set-up, protocol development, study monitoring, data and report review, and maintain timeline and study budget for each study.
- Leadership and oversight to ensure the selection and successful transition of gene therapy development candidates into clinical assets through the strategic scoping and curation of preclinical study packages supporting safety, toxicology, and pharmacokinetics that result in IND submission and clinical exploration of novel therapeutics.
- Direct the writing of regulatory submissions, such as for pre-IND and IND, particularly for preclinical sections.
- Analyze, interpret, and summarize nonclinical safety data, and present and contextualize meaningful findings and recommendations to internal project teams and leadership.
- Serve as a key resource, providing scientific knowledge and expertise to cross-functional project teams.
- Build strong collaborative relationships with research and development teams to meet project, departmental, and company goals.
- Ensure high scientific standards in conducting and reporting of nonclinical safety and investigative toxicology studies. Provide scientific leadership within Preclinical Safety.
- Prepare scientific publications and presentations from toxicology and safety pharmacology studies as appropriate.
- Align study designs and dose setting within Preclinical Development and Project Team.
- Provide written and oral presentations internally and externally, as required.
- Participate in project sub teams or departmental working groups.
- Design and oversee conduct of non-GLP investigative or GLP toxicology studies to support our platform and therapeutic programs.
- Analyze and interpret toxicology/safety pharmacology data and provide recommendations to the platform/program teams.
- PhD in pharmacology, toxicology or related areas, DVM degree, BS or MS with significant progressive experience
- At least 10-15 years of prior work experience at a biotechnology or pharmaceutical company in drug development and IND-enabling activities. Experience in neurology and gene therapy areas preferred
- DABT a plus
- Deep understanding of toxicology and in vivo pharmacology, and strong track record of driving research programs into the clinic
- Demonstrated ability to build cross-functional relationships and work collaboratively is a must.
- Proven track record in identifying and assessing the development potential of candidate drugs. Planning and execution of toxicology strategy, including risk assessment and authoring of reports and regulatory documents
- Demonstrated ability to advance programs from discovery through lead optimization and IND with small molecules, drug delivery platforms, and/or enabling formulations.
- Ability to work in small biotech setting with both strategic and operational objectives
- Excellent written and oral communication skills
- Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA, and other regulatory documents is required
- Strong interpersonal and communication skills, and able to build, influence and lead teams.
- Ability to travel to CRO to monitor outsourced studies.