Director Clinical Program Lead

Responsible for delivering clinical program goals on time, within budget, and with high quality-this includes driving operational strategy and making key decisions to support study and program objectives.

Develop and communicate operational plans, including supply chain strategies, to support execution of the broader Clinical Development Plan.

Collaborate closely with cross-functional leaders across development, regulatory, and other internal teams to align on program needs and timelines.

Lead and oversee execution of trials ranging from first-in-human through phase 4, in accordance with ICH/GCP, regional regulations, and internal SOPs.

Manage the selection, oversight, and performance of CROs and external vendors, ensuring alignment with clinical and corporate goals.

Lead feasibility and capability assessments for study sites in coordination with CROs and internal teams.

Drive innovative, patient-centered approaches to trial design and data collection, including exploration of digital platforms and novel research models, as well as potential external collaborations to enhance R&D progress.

Provide Clinical Operations insight into the development of key study documents such as protocols, investigator brochures, regulatory filings, study reports, and other deliverables.

Oversee and guide trial-level operations teams and vendors to ensure cohesive execution and high-quality outcomes.

Serve as the Clinical Operations representative in cross-functional project and vendor meetings, ensuring adherence to operational best practices and procedures.

Support external engagement with investigators, site staff, and thought leaders as part of the clinical development effort.

Maintain sponsor oversight of outsourced clinical activities, ensuring appropriate documentation and accountability at the study level.

Keep leadership informed of trial status, costs, and emerging risks to enable timely, informed decision-making.

Contribute to and support inspection readiness activities, including preparation for audits and regulatory inspections.

Take part in the development, review, and maintenance of SOPs to ensure ongoing compliance and consistency across the organization.

Participate in or lead internal workstreams focused on improving operational models and clinical development processes.

Cultivate strong working relationships across internal teams and external partners, including strategic collaborators.

Provide direct leadership to Clinical Trial Leads, offering guidance, coaching, and professional development; mentor team members in Site Operations to help prioritize and execute study-related tasks effectively.