Director, Clinical Operations

Company Overview:

Glycomine is a small clinical stage bio tech company committed to developing therapeutics for congenital disorders of glycosylation (CDG), serious rare diseases for which the vast majority of which do not have any disease-modifying treatment options available. Many of these diseases are driven by a genetic mutation that disrupts the function of an important enzyme. Glycomine’s lead clinical program in PMM2-CDG aims to deliver a substrate to bypass the enzymatic problem.

Our team has a special dedication to find solutions to the significant unmet medical need experienced by patients and families with rare diseases. We come from many disciplines and bring multiple viewpoints and broad expertise to our mission. We are driven by the imperative and the opportunity to develop therapies that can provide meaningful improvements in the quality of life for patients, caregivers, and families.

Overview:

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.

Responsibilities:

• Lead and oversee the strategic planning, implementation and execution of clinical trials across key programs in accordance with project timelines, budget, and quality standards
• Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies
• Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones
• Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for the program
• Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards
• Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct
• Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity
• Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports.
• Collaborate with senior leadership to craft key clinical documents (protocols, IBs, INDs), providing insights on operational feasibility and logistical considerations.
• Forge strong relationships with investigators, site staff, and CROs, effectively communicating complex scientific concepts while overseeing operational strategies for achieving program goals.
• Manage all vendor relationships, from budget negotiations to issue escalation, ensuring exceptional work quality, timelines, and budget adherence.
• Develop and execute operational risk management strategies
• Oversee the timely capture, reporting, and evaluation of adverse events and product safety issues.
• Develop and implement reporting standards for study progress metrics, providing timely data for comprehensive clinical study reports.
• Oversee clinical and regulatory files, including the essential Trial Master File (TMF).
• You will oversee the development of clinical trial project timelines and ensure communication and understanding of risks and challenges; establish plans and monitor metrics; ensure that timelines are accurate and comprehensive
• Work cross-functionally to coordinate the relevant and timely exchange of information and materials to support clinical trial deliverables
• Manage clinical trials from start-up through close-out to ensure that both internal and external deliverables are on time and on budget while collaborating across functional areas
• Proactively manage clinical trial outsourced partners, including identification of risk, to ensure trial deliverables and performance goals are met
• Maintain partnerships through positive relationships with CRO counterparts; proactively review and identify potential issues or problems with the sites and communicate/escalate to clinical leadership
• Collaborate with CROs to keep the clinical study database current, accurate, and routinely cleaned
• Manage the scope of work, change notifications, contract modification, site trial agreements, and other necessary budgetary information for clinical trial operations
• Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained

Qualifications:

• 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