Director - Clinical Operations

November 7

🇺🇸 United States – Remote

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🔴 Lead

⚙️ Operations

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Glycomine Inc.

WebsiteLinkedInAll Job Openings

2 - 10 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Series B on 2021-06

Description

• The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for our programs. • This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive a key program with multiple studies and indications through all phases of clinical trials (Phase I-III). • The Director will be a leader in the Clinical Development organization who knows how to manage a team internally, at our clinical sites, and with our vendors. • As the Director of Clinical Operations at Glycomine, you will play a pivotal role in driving the success of critical clinical programs. • You'll provide strategic leadership and operational expertise to guide our Clinical Development team, ensuring the seamless execution of clinical trials. • In this role, you'll collaborate across diverse functions to develop operational strategies, support key initiatives, and promote timely, on-budget trial completion that adheres to the highest quality standards. • You will be responsible for the planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations and directly managing and working with outside Clinical Research Organizations (CROs), clinical sites and their teams, and third-party vendors. • You will thrive in a fast-paced, innovative environment, while remaining flexible, proactive, resourceful, and efficient. • The ability to analyze complex issues to quickly develop relevant and realistic plans and recommendations for implementation is essential. • Also necessary are excellent matrix management skills, written and verbal communication skills, attention to detail, and knowledge of quality obligations.

Requirements

• BA/BS preferably in a health-related field; preferred MA/MS degree with major in biological, life science, nursing or related field • 10 + years of experience in clinical operations management within the pharmaceutical or biotechnology industry • At least 7 years of experience in the biopharma or CRO industry is required • Demonstrated excellence in managing clinical trials and a solid understanding of the trial processes • Proven track record of success and a history of innovative program and trial execution to ensure study progress, timelines, data integrity, and compliance with health authority requirements • Domain expertise in drug development, with a preference for experience in early-stage clinical trials • Strong vendor and project management skills are critical • Strong and up-to-date knowledge of Good Clinical Practices and ICH Guidelines, including their application in the conduct of clinical trials • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to, US CRF, EU CTD and ICH GC • Strong working knowledge of GCP/ICH and other applicable regulations/guidelines, required • Ability to manage multiple competing priorities and adapt to changes • Strong communication, interpersonal, and problem solving skills • Must be comfortable working in a fast-paced environment