Director, Clinical Operations

Job Description
Voyager Therapeutics seeks an exceptional candidate to lead Clinical Operations. This position reports into the Head of Clinical Development. The right candidate will possess an in-depth understanding of Clinical Operations for successful execution of early and late stage clinical trials and natural history studies.

Responsibilities:

The qualified candidate will have responsibilities both operational and strategic. The responsibilities include:

Participate in the design of clinical development plans and individual studies to ensure that study plans will meet stated objectives and predicted timelines for conduct.
Responsible for overall vendor strategy, selection of specific CROs and other vendors, creation and negotiation of contracts and/or work orders, and work performance.
Comprehensive management of the operational aspects of the Company’s clinical trials and observational studies, including domestic and international clinical CROs, central labs, biomarker and companion diagnostics trial operations and all clinical trial sites.
Identifies and pre-qualifies clinical trial sites and investigators alongside CRO. Participates in final decisions for site selection with Company’s team.
Day to day supervision of clinical study execution, with a focus on patient eligibility, enrollment, and data quality from the clinical sites and all vendors
Responsible for planning and monitoring clinical study budgets and execution timelines, with an emphasis on conducting these studies within the agreed budgets and study milestones/deadlines.
Attends and actively participates in/ leads investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
Develops and reviews strategy for operational efficiency; collaborates on SOP development and promotes standardized use of Clinical business tools
Actively participate in the design and development of high quality clinical trial protocols and amendments.
Development of high quality specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials;
Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
Participates in preparation and presentations of trial data for internal and external (advisory board, scientific meetings and advisory boards) use.

Education & Experience Requirements

Bachelor’s degree in a scientific discipline required. Advanced scientific or clinical research degree, such as an MPH, is a plus.
A strong background in clinical research methods and an ability to integrate scientific, clinical, and operational needs into clinical development plans and protocols.
The candidate should ideally have at least 8 years in Clinical Research/trial management with a minimum of 5 years of pharmaceutical or biotechnology experience. Working experience within a CRO or at a research site is also a plus
Experience in Phase 1-3 trials is required.
Experience in rare or orphan disorders is preferred.
Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
Creative problem solver with excellent communication skills.
Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.) and integrate input from the full range of stakeholders both in and outside the company
Ability to travel for up to 20% of time, both domestic and international, may be needed.
Global experience is preferred.
Detailed knowledge of GCP and current FDA regulations, and knowledge of other relevant global regulatory requirements a plus.

Company

Voyager Therapeutics, Inc.

Job Code

State or Province

Massachusetts

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