POSITION OVERVIEW:

Reporting to our Executive Director, Clinical Development Operations, the Director, Clinical Operations is responsible for ensuring that clinical stage programs achieve strategic and operational objectives within established timelines, budget, and quality standards. This role provides leadership to the Clinical Operations team, contributes to the development of clinical program strategies, and ensures superior execution, collaboration, and transparency across functions. The Director partners with internal stakeholders and external partners to drive high-quality clinical trial delivery in a fast-paced, small-to-midsize biotech environment.

Excellent study execution and oversight, budget and resource management, and oral/written communication skills are required, as is the ability to work in a collaborative, cross-functional team environment and with both in office and remote team members. The Director of Clinical Operations is responsible for creating and managing study timelines, budgets and study management plans in a fully outsourced model.

RESPONSIBILITIES:

• Lead and direct the execution of multiple global Phase 2/3 studies that align with study enrollment objectives and timelines.
• Responsible for line management of trial managers and CTAs and provides expert counsel for issue resolution.
• Provide Clinical Operations leadership under the director of the Executive Director of Clinical Development Operations.
• Contribute to the Clinical Development Plan(s) and associated operational strategy
• Work closely with Clinical Study Teams to develop and implement study plans.
• Accountable for the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines.
• Accountable for the oversight of Strategic Partners and other vendors to meet Disc’s obligations described in ICH-GCP and Disc’s business objectives
• Track key performance indicators (KPIs) for study milestone and communicate program status, cost and issues to inform timely decision-making by senior management.
• Assist in authoring key regulatory documents and ensure that clinical program deliverables align with submission requirements and regulatory expectations.
• Work closely with medical, regulatory affairs, data management, biostats, and medical affairs teams to ensure cohesive and compliant strategies.
• Share learnings and best practices across teams to enable process improvements.
• Stay abreast and keep teams informed of industry trends, emerging technologies and innovative recruitment solutions.
• Perform any other business need identified by their direct line Manager.

 REQUIREMENTS:

• BA/BS in relevant field required
• Approximately 10 years of experience in trial management, preferably within the biotech, pharmaceutical, or CRO industry.
• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
• Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously
• Comprehensive understanding of clinical development processes, GCP, ICH, and global regulatory requirements. Must be willing to travel both domestic and international
• Experience in orphan indications or oncology will be favorably considered
• Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
• Exceptional leadership, communication, and organizational skills.
• Highly organized with a positive attitude; Works well through change and shifting priorities
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., data management, biostatistics, regulatory, pharmacovigilance, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results.