Associate Director/Director, Clinical Operations

The Associate Director/Director of Clinical Operations will oversee the planning, execution, and closeout of all phases of clinical trials, ensuring they are conducted efficiently, on schedule, within budget, and in compliance with regulatory requirements. This role provides operational and implementation expertise, collaborating with team members to design, plan, and implement clinical development strategies. It includes ensuring appropriate oversight and timely execution of clinical plans. The position supports all phases of the company’s clinical research function, including clinical contracts management, final trial reports, data collection, IRT, and data management systems across all clinical indications and therapeutic areas, in line with standard operating procedures, regulatory guidelines, and medical standards. This role demands leadership, strategic oversight, and hands-on management of clinical study teams, vendors, and CROs.

What you'll do:

• In this role, you will oversee the planning, execution, and closeout of clinical trials, ensuring that all phases are conducted efficiently, within budget, on time, and in compliance with regulatory requirements. You will lead cross-functional clinical study teams, providing both operational leadership and strategic oversight to ensure that project milestones are met and that studies align with organizational objectives. Your responsibilities may include the development, planning, and management of financial aspects, including budget forecasting, site payments, and overall financial management, ensuring that all clinical trials contribute to the organization’s financial goals.
• You will evaluate, select, and manage external vendors and CROs, providing the necessary oversight to ensure that these partnerships are optimized for success. Additionally, you will support and oversee the management of clinical contracts, ensuring that all contractual obligations are met and aligned with the strategic goals of the clinical programs. This may include managing site payments, handling contract negotiations, and ensuring compliance with legal and regulatory standards.
• You will also play a crucial role in data oversight, collaborating with data management teams to ensure data integrity, quality, and compliance across all clinical trials. Your input will be essential in the development and approval of key study documents, ensuring they meet regulatory standards and support the successful execution of clinical trials. Furthermore, you will drive operational excellence by developing and refining SOPs, processes, and best practices, continuously seeking opportunities for process improvement to enhance efficiency, compliance, and performance.
• As a leader, you will provide high-level strategic direction for clinical operations, aligning clinical activities with corporate goals and ensuring the successful execution of complex clinical programs. Approximately 10-15% travel may be required to support these activities, and you will also take on additional responsibilities as needed, adapting to the evolving needs of the organization and clinical programs.

About you:

• Qualifications for Associate Director: 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.
• Qualifications for the Director (in addition to Associate Director, Clinical Operations experience):
• 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.
• 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.