Associate Director - Clinical Operations

September 2

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Adverum Biotechnologies

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We are on a global mission to establish gene therapy as a new standard of care for highly prevalent ocular diseases.

Gene Therapy • Biotechnology • Rare Diseases • Ophthalmology • Retina

51 - 200

💰 $217M Post-IPO Equity on 2020-08

Description

• Oversee planning, execution, and closeout of clinical trials efficiently, within budget, on time, and in compliance with regulatory requirements. • Lead cross-functional clinical study teams providing operational leadership and strategic oversight. • Evaluate, select, and manage external vendors and CROs, ensuring partnerships are optimized. • Support management of clinical contracts, ensuring compliance with legal and regulatory standards. • Play a crucial role in data oversight, ensuring data integrity and compliance across all clinical trials. • Develop and refine SOPs, processes, and best practices for operational excellence.

Requirements

• Bachelor’s degree preferred. Certification in a health-related field or an Associate's degree is required, in a healthcare or scientific-related discipline. • At least 5 years of direct clinical operations experience in a pharmaceutical, biotechnology, and/or CRO setting. • Strong understanding of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing clinical trials. • Demonstrated ability to manage phase 1-3 studies independently. • Proficiency in Microsoft Office (Word, Excel, PowerPoint, MS Project) and experience with IVRS and EDC systems is a plus. • Strong attention to detail, organization skills, and the ability to prioritize multiple tasks. • Strong verbal, written communication, and presentation skills. • Ability to work effectively in a team/matrix environment and lead cross-functional teams. • Strong interpersonal skills with the ability to engage and influence stakeholders at all levels. • Experience in gene therapy and/or rare disease indications preferred. • Bachelor’s degree required, with significant experience in a health-related or scientific discipline. Advanced degree (Master’s or above) preferred. • 7+ years of progressive clinical operations experience, with at least 5 years in a leadership role within a pharmaceutical, biotechnology, and/or CRO setting. • In-depth knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs, with a proven track record of successfully managing and leading complex clinical trials. • Extensive experience in managing and mentoring clinical operations teams, as well as in the strategic oversight of phase 1-3 studies. • High proficiency in Microsoft Office (Word, Excel, PowerPoint, MS Project) and advanced experience with IVRS, EDC, and CTMS systems. • Exceptional strategic thinking, problem-solving, and decision-making skills. • Experience in supporting and overseeing clinical contracts management to ensure contractual obligations align with the strategic goals of clinical programs.

Benefits

• Approximately 10-15% travel may be required to support these activities. • Additional responsibilities as needed, adapting to the evolving needs of the organization and clinical programs.