Reporting to the Head of Clinical Operations the Clinical Operations Lead will provide operational leadership and expertise in the implementation of clinical development programs. In conjunction with the cross-functional project team, the Clinical Operations Lead is responsible for overseeing the coordination, management and operational aspects of Clinical Programs to ensure successful completion of projects and ensure delivery of company goals on time, within budget, and in compliance with SOPs, Regulatory Authorities and ICH/GCP guidelines.
- Provide operational and implementation expertise to AVROBIO’s program teams to enable timely progression of clinical development programs
- Ensure successful enrollment planning, implementation and conduct of all assigned clinical trials
- Work with the project team to identify and evaluate issues in the program, interpret data on complex issues and suggest and implement solutions
- Assist with the development of the clinical components of regulatory submissions
- Work on complex program issues in which analysis of situations or data require an in-depth evaluation of various factors
- Ensure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing study specific goals, tracking metrics and producing and presenting summary reports
- Lead and mentor others in the clinical development process
- Participate in design and development of clinical trial protocols, investigational brochures and other program related materials
- Determine study requirements, define specifications, and initiate and lead the selection of third party vendors
- Oversight of CROs to ensure timelines of clinical development plans are met
- Development of specific study documents (informed consent forms, study guidelines, operation manuals & training materials
- Responsible for oversight of identification and selection of investigator sites.
- Responsible for planning and conducting investigator’s meetings.
- Monitors the status of clinical data collection of assigned clinical studies.
- May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
- Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites
- Responsible for the ensuring the integrity and successful transition of the Trial Master File.
- Provides input as the subject matter expert for the study during regulatory inspections
- Develops and monitors budget for clinical program, and reviews budgets and contracts with CROs, vendors, and investigative sites (as applicable).
- Provides input into contracts, change orders, and/or work orders.
- Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations.
- Supports department initiatives and process improvements.
- All other duties as assigned
- Bachelor’s degree or nursing qualification in a scientific field of study with 8+ years of relevant experience working in Clinical Operations in the Pharmaceutical/ biotech industry or a CRO.
- Strong collaboration and team-working, communication and organizational skills required, entrepreneurial spirit with “can do” attitude, commitment to teamwork, and initiative
- Proven regulatory submission experience with the desire and ability to work in a fast-paced environment
- Excellent working knowledge of FDA & ICH/GCP regulations and guidelines and experience in clinical operations groups.
- Demonstrated project management/clinical operations experience and leadership skills (e.g., managing cross functional study teams, managing outside collaborators)
- Strong written and verbal communication skills; effective in interaction with senior management
- Excellent judgment and problem-solving skills
- “Hands-on” ability to think strategically and tactically
- Knowledge and experience with managing contracts and budgets (vendor and site) and interfacing with finance group
- Strong knowledge of applicable computer and project management software packages
- Ability to interact with investigators, vendors, and individuals at all levels of the
- Available for up to 25% domestic and/or international travel.
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AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.