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 seeking an Associate Director, Clinical operations, who is an exceptional, experienced, and high energy individual with significant clinical drug development knowledge of early and late phase trials to help build a high performing team and growing department. This individual will be responsible for implementing the strategic plans for Clinical Operations and overseeing Clinical Operations staff in the conduct of Phase I-IV clinical trials across multiple therapeutic areas in accordance with GCP, CFR, and ICH regulations. This position reports to the Director of Clinical Operations.
- Responsible for development of clinical operations strategic plans, overall study budgets (including forecasts and accruals) and timelines for assigned clinical programs including tactical execution in accordance with Company goals, objectives, and budget
- Partner with Medical Director and Program Team Lead to develop and implement Clinical Development Plan (CDP) and function as Sr. Clinical Operations Lead on internal Program Team
- Provide clinical operations leadership and comprehensive oversight to all operations functions and Clinical Trial Managers under assigned clinical programs
- Partner with Clinical Trial Manager and other functional areas within Voyager, CROs, and third-party vendors to ensure clinical trials are executed on time and within established budget
- Play a key role in oversight of CRO partners and other vendors, functioning as the escalation point for issues/risks to Sr. Management, including risk mitigation/remediation plans
- Support Clinical Trial Manager with identification of potential vendors, development of RFPs, scope of service agreements and/or change orders
- Develop strong relationships with investigators and site staff, and ensure study is conducted in accordance with established company processes and SOPs
- Contribute to departmental resourcing and recruitment plans to ensure proper timing and allocation of resources to clinical studies to achieve study timelines and deliverables
- Directly manage staff (Clinical Trial Managers, Clinical Trial Associates) with responsibility for staff training and mentoring, performance management, setting individual employee goals and career growth opportunities for staff. Also lead FSP and contract staff who may be remote to Voyager’s offices.
- Collaborate with Director of Clinical Operations to define and monitor key performance indicators and departmental metrics, as well as identification of opportunities for process optimization, training needs, and procedures (SOPs, Work Instructions)
- Participate in departmental and cross-functional process improvement initiatives, often as initiative or workstream leader
- Champion best practice development in planning, conduct, and reporting of clinical studies and sharing knowledge/information to support innovation and efficiencies across study teams
- Contribute to development of departmental goals and objectives to achieve corporate goals
- Ensure timely and clear communication to staff on updates, progress, decisions from Sr. Management
- A minimum of a Bachelor’s degree in science or related field is required
- Advanced degree (i.e. Master’s, PhD, PharmD, etc.) preferred
- A minimum of 10 years of significant work experience in the biopharmaceutical industry, with experience executing clinical trials globally across all phases of development
- Exceptional leadership and interpersonal skills with an ability to effectively work and identify resolutions to challenges within a multidisciplinary team and to effectively lead external vendors/CROs
- Significant experience with line management of employees
- Consistent track record of successfully leading staff to deliver clinical trials on time, on budget and with quality while ensuring inspection readiness
- Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a small-sized. Fast-paced company environment
- Excellent organizational, written communication, and presentation skills
- Excellent oral and written communications.
- Strong understanding of GCP, CFR and ICH guidelines
- Proficient computer skills including knowledge of Microsoft Excel, Word, Powerpoint, Project, and Outlook.
- Prior CNS or gene therapy experience preferred.
- Travel up to 15% as needed (Domestic/ Int’l)