Senior Director/Vice President Drug Delivery
Voyager Therapeutics is developing life-changing gene therapies for fatal and debilitating diseases of the central nervous system. Our founders include scientific and clinical leaders in the fields of adeno-associated virus (AAV) gene therapy, expressed RNA interference and neuroscience. Our management team has deep expertise and a track record of building exceptional life science companies.
Voyager Therapeutics is developing recombinant adeno-associated virus (AAV) vectors for treating neurological diseases. Robust translation of drug delivery from research to the clinic is central for enabling successful gene therapy clinical trials. Voyager seeks a highly motivated scientist experienced with both direct CNS drug delivery and AAV to lead the drug delivery efforts. Extensive knowledge of innovative approaches to enhance distribution and penetration within specific areas the CNS required. The Senior Director/ Vice President of Drug Delivery will oversee research and preclinical studies exploring and optimizing AAV drug delivery directly to the CNS, and lead the translation of drug delivery from research to the clinic. Specifically the roles and responsibilities of the position are to:
- Formulate the strategic direction of Voyager’s delivery work in collaboration with the senior management team and in the context of specific on-going and future programs.
- Provide general leadership for all drug delivery work to provide strategic direction and establish long-range goals and plans.
- Identify new technologies and assess their potential to complement Voyager’s assets and enhance the company’s pathway to success.
- Participate in writing and reviewing components of new regulatory submissions, particularly with regard to drug delivery sections.
- Participate in the design and interpretation of clinical studies with regard to the drug delivery issues.
- Initiate and oversee collaborations with academic and industry labs.
- Develop drug delivery project plans, communicates changes and progress, and shares expertise with others.
- Attend relevant scientific conferences to network with academia and industry, and to stay current in relevant research.
The ideal candidate for this position will have extensive translational experience with drug and drug:device combination therapies for CNS disorders from preclinical discovery through Phase II/III pivotal trials. Specifically, the candidate would have in-depth familiarity with drug:device targeted drug delivery to the CNS, including direct intraparenchymal brain delivery with CED, and delivery into the cerebrospinal fluid. The ideal candidate for the position will have extensive experience with CNS delivery studies in large mammals, labeled drug candidates for biodistribution evaluation, and modeling of PK/PD in the CNS for scaling from preclinical species to humans. In addition, in-depth knowledge of neurological disorders, including at least several neurodegenerative diseases, is required. Some familiarity with AAV is strongly preferred. The successful candidate will have supervisory experience overseeing contracted studies, and scientific and technical staff. Importantly, the ideal candidate will have a track record of successful translation of drug candidates to the clinic, with significant knowledge of clinical trial design and regulatory strategy as relates to drug:device combinations and drugs administered directly to the CNS. This individual will function in the fast-paced, biotech start-up environment and interact with multi-disciplinary research teams at Voyager’s facility in Cambridge, Massachusetts.
- Ph.D. in a biological science (preferably neuroscience) with at least 15 years of subsequent industry experience focused on drug discovery and development
- Minimum of 12 years’ experience in a leadership and supervisory role in industry
- Minimum of 8 years in-depth experience with discovery and development of drug:device combinations, including familiarity with regulatory requirements
- Track record of successful clinical translation from research
- Significant experience with drug discovery and development for neurological disorders, including neurodegenerative diseases
- Outstanding organizational skills
- Ability to be highly productive and flexible in a fluid and fast-paced work environment
- Several years’ experience with AAV
- Experience within a start-up or small biotech environment