Associate Director, Clinical Operations

11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry.

Experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets.

Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

Experience with vendor management and CRO oversight.

Ability to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.

Proven success working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

Oversee the successful management of all aspects of clinical trials within timelines and designated program budgets.

Strategic thought partner on the development, management, and execution of the Clinical Development Plan (CDP) for assigned clinical programs which includes timelines, budget, and resource requirements.

Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks.

Lead line management responsibilities that include hiring, performance management, career development, and mentorship.

Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and KPIs.