Director Clinical Affairs Job at ALKU, Santa Clara County, CA

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  • ALKU
  • Santa Clara County, CA

Job Description

Associate Director of Pre-Clinical & Clinical Affairs

Description :

Our client is seeking an experienced Clinical & Preclinical Affairs Consultant to oversee and drive the clinical and preclinical strategy for a pivotal robotics project. In this role you will be the sole individual responsible for both clinical and preclinical initiatives, ensuring seamless project execution and successful outcomes.

Responsibilities:

  • Own and develop clinical and preclinical strategies, ensuring alignment with organizational goals and regulatory requirements.
  • Interface directly with pulmonologists to cultivate and support investigator-initiated studies.
  • Manage 1-2 studies that are nearing completion, overseeing all aspects from execution to publication.
  • Provide strategic oversight and guidance for preclinical study protocols, ensuring regulatory compliance and timely approvals.
  • Develop and present clinical and preclinical strategies to leadership, ensuring all stakeholders are aligned and informed.
  • Lead regulatory submission processes and ensure successful approvals for preclinical testing.

This is a high-impact role where you will drive clinical and preclinical success, working closely with both internal teams and external partners.

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