Clinical Specialist, Clinical Cell Delivery

Clinical Specialist, Translational MedicineOnsite, South San Francisco – Bay AreaCompany Overview:

Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of cell-based therapies for neurological diseases.

We are seeking a self-motivated and adaptable Clinical Specialist to join our Translational Medicine Team. In this role, you will play a critical part in guiding the administration of cellular therapeutics during patient procedure enrollment. Clinical Specialists will serve as primary representatives of Neurona within operating rooms during surgery for a Pivotal Phase III Clinical Trial, participate in surgical staff training and technical transfer, and provide surgical device and cell investigational product technical support.

Key Responsibilities

• Serve as a technical expert and scientific support representative at clinical sites during patient enrollment activities.

• Lead and participate in the training and technology transfer of cell administration procedures to clinical staff.

• Acquire and apply an in-depth knowledge of appropriate cell preparation processes, cell delivery procedures, and clinical trial protocols.

• Manage site preparations from subject identification through subject enrollment.

• Ability to maintain strict adherence to study blinding procedures and protect blinded information throughout clinical trial activities.

• Establish, foster, cultivate, and maintain relationships with KOLs and clinical site staff.

• Contribute to the development of new processes for administering cellular therapeutics.

• Manage equipment and material inventories throughout studies.

• Understand and adhere to SOPs, proactively report compliance concerns and adverse events, and contribute to continuous process improvement.

• Present data at team meetings and generate scientific reports to support regulatory submissions.

• Gather, analyze, and internally communicate technical surgical information and feedback from clinical investigators

• Demonstrate strong follow-through and closure of responsibilities and assignments.

• Frequent travel to clinical sites is required, approximately 50% effort

Qualifications

• Advanced Clinical/Science Degree (e.g., MD, PharmD, PhD, MSN, RN, NP, PA etc.) or

• Bachelor’s degree in Biology, Biomedical Engineering, Neuroscience or related field; with a minimum of 4 years related work experience

• Master’s degree in Biology, Biomedical Engineering, Neuroscience or related field; with a minimum of 3 years related work experience