Octapharma USA, Inc. is seeking an Associate Director/Director of Clinical Operations for its beautiful Paramus, New Jersey headquarters location. 

Octapharma USA, Inc. offers competitive pay, outstanding benefits and a collegial work environment.

Position Summary:
This position reports into the Sr. Director of Clinical R&D. The Associate Director/Director of Clinical Operations will contribute to and lead the development and implementation of national/international clinical studies in the fields of Hematology and critical care from protocol development to regulatory submissions. Responsibilities include providing leadership to staff and study teams to ensure trials are conducted in accordance with the protocols, standard operation procedures (SOPs), and Good Clinical Practice (GCP), and other regulatory requirements. Establish and lead meetings with CROs, and other trial vendors and serve as a key point for teams, vendors, investigators, and key opinion leaders. The Associate Director/Director will contribute Clinical Operations expertise in cross-functional department initiatives.  

Key Requirements and Responsibilities:
MS, PhD, or MD, preferably in a healthcare or life science discipline (advanced degree preferred)
At least 10+ years of experience in managing clinical trial operations including multinational/multisite clinical studies.

Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements as well as ICH and GCP guidelines.

Collaboration with cross-functional teams globally to ensure timely delivery of assigned studies within budget.

Contribute to Clinical Study Reports, INDs, NDAs/BLAs and other clinical, regulatory, safety documents.

May contribute to development of abstracts, presentation, and manuscripts.

Experience with financial budgeting and reporting.

Ability to act flexible and swift in challenging situations and changing environments.

Ability to interact with investigators, vendors, and individuals at all levels of the organization.

Travels nationally and internationally as required.