Mission The Associate Director Clinical Project Management is an expert in clinical operations and project management, and is responsible for oversight and management of AGTC-sponsored clinical trials, including leading teams to deliver high priority projects on time with high quality.
Reporting Relationship • The Associate Director Clinical Project Management will report directly to the Director of Clinical Project Management or designee
Duties and Responsibilities • Lead cross-functional teams to drive the delivery of high priority projects/programs • Manage all aspects of clinical trial(s)/program from study start-up through study close-out • Assess operational feasibility and develop/implement the study execution plan, including • Develop and manage comprehensive study timelines and metrics • Lead and/or contribute to the development and implementation of vendor oversight plans to effectively manage and assess vendor performance to ensure high-quality deliverables • Plan, execute and lead study-specific meetings • Identify and implement opportunities to optimize/enhance processes and/or systems to accelerate projects/programs • Proactively identify risks to study timelines and budgets and implement risk mitigation strategies/solutions • Ensure clinical trials are executed in compliance with national/international GCP guidelines/regulations and SOPs • Oversee development of study related documents, including, but not limited to, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Statistical Analysis Plans (SAPs), etc. • Provide regular status reports to management as appropriate • Ensure studies are conducted in accordance with applicable regulations, GCP guidelines, protocol and affiliated documents and operational strategy • Participate in the planning of Quality Assurance activities and oversee resolution of audit findings • Ensure audit-ready condition of Clinical Trial Master Files
• Provide routine status reports and updates to senior management committee • Participate in the development of SOPs and clinical operational systems • Work with manager to develop and achieve corporate goals within expected timeframe, ensure goals are set and communicated to direct reports
Educational Qualifications • B.S. in a scientific discipline and at least seven (7) years’ experience in Pharmaceutical, Biotech or CRO company, including experience with all aspects of trial and site startup and vendor management.
Additional Qualifications • In-depth knowledge of all aspects of drug development across Phases 1-IV, including GCP, ICH and FDA regulations • Self-motivated, flexible, and independent thinker • Ability to work in a fast-paced/demanding environment • Problem solver, ability to prioritize and/or multi-task • Collaborative team member • Ability to work independently and as part of a team in a fast-paced environment • Ability to juggle multiple competing tasks and demands • Proficient in use of Microsoft products (Word, Power Point, Excel, Project) • Excellent oral and written communication skills • Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships, including vendors, CROs, etc.
Supervisor Responsibilities Previous management or supervisory experience required
AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases, with an initial focus in ophthalmology. AGTC's lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments.
AGTC's product pipeline includes six named ophthalmology development programs across five targets (X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), achromatopsia, wet age-related macular degeneration and blue cone monochromacy), two non-ophthalmology programs (alpha-1 antitrypsin deficiency and adrenoleukodystrophy) and AGTC is continuing to develop early research studies in additional indications. The company is also exploring genetic defects in cells in the inner ear that lead to deafness and expects to advance several product candidates into development within the next few years.
AGTC employs a highly targeted approach to selecting and designing its product candidates, choosing to develop therapies for indications havin...g high unmet medical need, clinical feasibility and commercial potential. AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as, expertise in the formulation, manufacture and physical delivery of gene therapy products
Find AGTC on YouTube at goo.gl/sMdJqX.