Career Opportunities in the Foresite Capital Network

About Voyager

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

Job Summary:

Voyager Therapeutics is seeking a talented leader to join our team and advance our pipeline further into development. The Vice President of Development Operations and Program Leader is a strategic position which will architect, lead and drive tactical strategy and operationalization of all development operations, from Clinical Operations through Program Leadership. This comprehensive role seeks an experienced person with a background in clinical operations with a successful track record of prior IND filings and Ph I/II clinical trial execution and who has also experienced broader enterprise leadership in a Program Leadership capacity. The successful candidate will leverage their development experiences to be a flexibly utility leader within a growing organization.

Key Responsibilities:

Development Operations

• Establish and optimize clinical operations processes and procedures to enable effective clinical trial planning and execution based on current needs of company with the ability to enable future scale and growth.
• Build, develop and lead a team of clinical operations professionals using a strategic mix of permanent employees and consultants, work cross-functionally and lead a clinical study team comprising internal team members and external consultants and CRO partners.
• Strong clinical operations systems experience and demonstrated ability to develop and implement effective, phase-appropriate clinical operations processes and controls in a dynamic, high growth business environment.
• Ability to drive the Company’s compliance with all relevant regulatory and quality requirements for clinical trial planning and execution. Experience interacting with Health Authorities, including inspection readiness.
• Identify, negotiate, manage, and maintain strategic partnerships with CRO’s, KOLs, clinical sites, and vendors in order to achieve program milestones within established timelines and on budget.
• Direct the implementation of clinical SOPs that meet GCP, ICH, EMA, and FDA requirements.
• Monitor and manage overall performance from protocol design finalization to regulatory submission.
• Provide clinical trial insights into project and portfolio operational risks and develop and implement mitigation actions.

Program Leadership

• Drive the asset strategy and lead all development and life-cycle management (LCM) projects associated with an asset from the time of preclinical candidate nomination to when it completes all registration-enabling studies as a marketed product. The PL will also lead initiatives to improve timelines/cost to market (e.g. remote trials, improving asset strategy)
• Ensure that risks and challenges are addressed proactively and collaboratively with partner functions, with joint decision making when appropriate to drive, deliver and maximize asset value
• Facilitate the Program Steering Committee in setting program vision and strategy. Defines goals, priorities and long-term plans and schedules. Aligns cross-functional, cross-divisional project goals with Voyager business needs and strategies.
• Coordinate all activities involved in interactions with FDA and other regulatory authorities and key opinion leaders with respective functions.
• Proactively and regularly identifies/monitor project risks before they transform into issues and develops well thought through contingency plans; communicates timely and proactively project-related issues to senior executive management and manages issues to resolution.
• Work closely with team members to provide strategic, process, and operational leadership in the successful delivery of projects from discovery to commercialization and life-cycle management (LCM) activities.
• Link cross-functional sub-teams, such as the Clinical, Regulatory, Commercial, etc. to execute according to the defined program plan. Align and ensure transparency of all program-related activities.
• Effectively and proactively reports on progress of projects, plans/plan changes, critical path, possible scenario and issues/risks/impact to executive management through internal or external reviews.
• Effectively leads and represents the team across multiple governance and relevant internal meetings relevant to the ALS program.
• Accountable for project operating budgets, monitor and control expenditures; manages variance between budgeted and actual expenditures of time, dollars, and personnel.
• Manage internal and external resources (people, information, technologies, time, and capital); allocates project resources appropriately, given division, function and individual goals and objectives to align with business imperatives.
• Proactively responds to the dynamics of a changing marketplace; directs adjustments in functional or cross-divisional plans in response to changes in strategic direction.
• Provides mentorship to the members of the teams that they oversee. Partners with functional leaders to advice and mentors team members on professional development opportunities.

Qualifications

• Graduate degree required (MBA, MD, PhD, or PharmD)
• Minimum of 12 years related experience in the pharmaceutical industry, with working knowledge of research and development and development operations.
• Minimum 8 years' experience with complex projects including experience with prior IND filings and Ph I/II clinical trial execution.
• Broad business/enterprise orientation - Track record of recruiting, developing, and leading high performing teams, and augmenting in-house resources with experienced team of consultants as required.
• Experience spanning all stages of clinical development process from IND- through NDA/BLA, ensuring proactive identification of issues and deploying creative solutions to maintain or accelerate timelines.
• Ability to be a versatile and highly strategic enterprise leader.
• Highly collaborative cross-functional leaders with demonstrated experience consistently driving top performance and delivering against challenging goals.