What are the responsibilities and job description for the Director Clinical Affairs position at ALKU?
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.