Chief Medical Officer
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 outstanding physician scientist to join our Senior Leadership Team as Chief Medical Officer (CMO). The successful candidate will lead strategy and execution for the clinical and medical development of our novel TRACER AAV capsid discovery platform programs in neurological disease. The successful candidate will have direct medical responsibility for creating overall clinical development plans, designing clinical studies, writing protocols, medical monitoring, and ensuring timely execution of clinical studies.
Reporting to Voyager’s Chief Executive Officer, Al Sandrock, the CMO will work collaboratively with other senior and functional leaders to produce integrated development strategies and to drive program prioritization. Our CMO will maintain a blend of strategic and operational accountabilities and will serve as an organizational spokesperson in external interactions with health authorities, investors, at scientific and medical meetings, and with our collaborators. The successful candidate will thrive in a proactive, fast-paced ‘can-do’ culture and enjoy collaborating across the full range of development activities for Voyager’s programs.
- Provide clinical leadership for Voyager’s drug discovery and development, and oversee clinical development, regulatory affairs, clinical operations, medical affairs functions.
- Act as our internal clinical/medical advisor for projects from research through development.
- Lead the design of clinical development plans, study protocols and interpretation of clinical study data. Execute drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
- Build a robust, forward-thinking development team at the appropriate inflection points in order to support all goals and timelines. Strategically evaluate the balance between outsourcing and in-house approaches for the various clinical development needs.
- Until team is hired or as needed, conduct investigator meetings and lead site initiation visits with clinical trial investigators.
- Implement safety strategy across studies, including regular review of safety data and response to safety issues. Oversee team responsible for clinical trials for safety and, when appropriate, efficacy, and ensure timely generation of clinical study reports and reporting of safety signals to regulatory
- Oversee clinical sections of regulatory documents (e.g., pre-IND meeting packages, IND/CTA, IB, ICF and BLA/NDA), prepare for meetings with FDA and healthcare authorities and organize and prepare for Clinical Advisory meetings.
- Manage the writing of clinical protocols, presentations, and publications.
- Maintain accountabilities for all relevant timelines and deliverables. Lead team to secure global regulatory approvals for pipeline products.
- 10+ years of demonstrated progressive experience in clinical development leadership.
- Documented success in advancing therapeutic programs through clinical
- Experience in CNS diseases or neuromuscular diseases.
- Experience in gene therapy drug development, RNA, nucleotide, and/or gene editing experience considered a plus.
- Experience working as part of an executive leadership team, with board members, KOLs, regulatory bodies, and investors.
- Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company, fast-paced
- Marked proficiency in clinical/medical writing.
- Experience in early-stage and late-stage development programs.
- Demonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Self-starter who works with a sense of urgency and functions as a strong team player.
- Patient focused, passionate about science an excited about having fun while working
- Entrepreneurial thinking and actions. This includes the ability to identify challenges and concurrently offer solutions to those challenges that make a difference to our business.
- Compelling judgment calls. Critical judgments will enable greater benefit to all stakeholders.
- Highly effective communicator; written and
- Remarkable people skills to enable high individual and high team performance. Actions and thoughts will play a key role in creating a thoughtful, respectful, continuous learning, action oriented, product focused, patient minded and value seeking
- Remarkable teaming skills to bring cross functionality with the Senior Leadership Team
- Able to use process as an effective management tool vs being driven by
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