Gan & Lee Pharmaceuticals USA is seeking an experienced Director, Clinical Operations, reporting to VP, Clinical Excellence, to lead the planning, execution, and oversight of company sponsored clinical trials. This is a key leadership role responsible for driving study strategy, ensuring operational excellence, and guiding cross-functional teams to deliver high‑quality clinical programs. The position can be located in either US or Denmark.

Education and Credentials

• Minimum of a Bachelor of Science degree in Nursing, Pharmacy, or scientific field, or equivalent.

Experience

• Minimum 6 years direct pharmaceutical industry experience in clinical operations with a master’s or doctorate level degree.
• Minimum 8 years direct pharmaceutical industry experience in clinical operations without an advanced degree.
• Previous leadership experience is preferred

Skills

• Must have well-developed communication skills (both oral and written) and be able to work effectively in cross-functional teams both internally and externally to the organization.
• Proficient in Microsoft applications including Word, Excel, Project, and PowerPoint.
• Demonstrated working knowledge of the principles of drug development.
• Demonstrated ability to manage one or more large, complex clinical trials.
• Demonstrated capacity to contribute to study design.
• Proficiency in GCP and ICH regulations.
• Efficient, organized, and capable of prioritizing multiple tasks.
• Willingness to adapt to changing priorities and assignments.
• Strong attention to detail.
• Knowledge in the Diabetes/Endocrinolog/Weight Management areas preferred.
• Experience supporting regulatory submissions preferred.
• Experience with Vendor Management preferred.

Responsibilities

• Responsible for oversight of direct and indirect reports, including administrative budget oversight.
• Ensure quality and compliance in all action by adhering to Company policies and procedures.
• Exercising the highest level of integrity in the tasks performed.
• Embracing a commitment to doing the job right the first time.
• Ensuring employees and/or contractors under scope of responsibility are trained in required procedures for the execution of their role and remain current with training requirements during the year.
• Promoting an environment of employee engagement in the workplace.
• Seeking prompt identification, reporting, and correction of deviations in the workplace as noted by employees.
• Collaborate in the operational design and conduct of clinical studies sponsored by the Company, from protocol feasibility through database lock, study report generation, and submission activities.
• Provide input on protocols and amendments.  Participate in protocol reviews.
• Prepare/oversee study-specific documents including informed consent documents, status update reports, and training materials. Participate in review of electronic case report forms (eCRFs), CRF completion guidelines, data management plans, statistical analysis plans, inspection readiness plan, monitoring plans, etc.
• Manage preparation of Budget and Invoice Tracking, Forecasting, Monthly Updates to Senior Management, etc.
• Actively participate in the evaluation and selection of qualified external service providers (ESPs) (e.g., CROs, laboratory vendors), investigators, etc. and lead the contracting process with certain vendors that the Company contracts with directly. Communicate study specifications to CROs.
• Collaborate with Legal to ensure timely review of documents, including confidential disclosure agreements (CDAs) and clinical trial agreements (CTAs).
• Serve as the primary point of contact with certain CROs.
• Ensure Sponsor oversight by monitoring the progress of studies and performance of CROs on a continual basis through status update meetings, review of monitoring plan, review of monitoring visit reports, maintenance of study progress via paper and electronic data capture, including timely databasing of eCRFs, routing/resolution of queries, SAE review and reconciliation.
• Ensure that all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure patient safety, quality data, and accurate study timelines, and that budgets and quality standards are met.
• Oversee the setup and maintenance of the Trial Master Files (TMFs) (with the CROs and inhouse) in real time so TMFs are inspection-ready at all times.
• Manage study timelines including key milestones. Identify and manage critical path activities; anticipate bottlenecks and ensure contingency plans are in place and negotiated with the external service providers to mitigate risk. Help team identify and address system or process issues hindering delivery of high-quality data results within the specified study timelines.
• Oversee and track subject recruitment and retention. Oversee development of enrollment plan, risk mitigation, and site recruitment strategies. Coordinate the review/approval of study-specific recruitment materials.
• Generate and update protocol-specific documents required for registry/posting of clinical studies on public registries (e.g., clinicaltrials.gov). Secure approvals of these documents.
• Oversee development, negotiation, and management of clinical trial budgets, CTAs, and Letters of Intent (LOIs). Track payment schedules against key deliverables.
• Approve invoices from vendors in order to ensure timely disbursement of payment and compliance with contracts and study budgets.
• Apprise Management of study-related issues that arise. Participate in the generation of corrective and preventive action plans to address issues.
• Work collaboratively and cross-functionally (both internal and external to Company).
• Generate protocol-specific documents required for posting of study results on public registries (as needed).
• Acquire clinical knowledge of the therapeutic area(s) and compounds under development. Acquire working knowledge of global regulations and guidelines as it pertains to clinical research.
• Forecast and coordinate clinical and non-clinical supplies requests, review drug label and kit designs, initiate drug shipment, manage drug accountability, and review drug destruction/return policy.

Leadership Capabilities

• Demonstrate strong leadership presence and act as a role model for the team.
• Foster a culture of accountability, collaboration, and high performance.
• Prioritize people development by coaching, mentoring, and enabling others to grow.
• Seek continuous improvement of own leadership skills through feedback, reflection, and learning.
• Communicate clearly, transparently, and with purpose to ensure alignment and motivation.
• Drive decision‑making with confidence, balanced judgement, and a solution‑oriented mindset.
• Lead through change by providing clarity, stability, and support to the team.
• Cultivate an inclusive and respectful work environment where diverse perspectives are valued
• Provide mentoring for junior employees, interns, or consultants, as appropriate.

Policies and Procedures:

• Ensure study compliance to Company quality standards/processes and GCPs.
• Contribute to departmental process improvements.
• Provide leadership for specific departmental initiatives.
• Champion operational excellence to provide continuous improvement of processes and sharing of best practices/lessons learned.
• Facilitate effective decision making.
• Propose alternative study operation strategies to optimize use of time, cost, and resources.
• Manage critical changes and/or variance in financial forecast, schedule, scope, and deliverables.
• Perform other duties as required.