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Job description
Clinical Specialist, Translational Medicine
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 2 years related work experience
Clinical trial experience required; experience supporting Phase II or later-stage blinded clinical trial activities preferred.
Previous experience in device design, biomedical engineering, or related technical fields.
Preferred previous experience in cell culture techniques, including processing cell suspensions, preparation, and maintenance of cell lines.
Experience in a clinical setting, GCP (Good Clinical Practice), or surgical device support is a plus.
Experience in creating and delivering scientific presentations, basic experience in medical writing
Ability to interact and communicate clearly, professionally, and effectively with physicians, nurses, and other external clinical staff.
Familiarity in clinical or non-clinical cell delivery methods and technologies
Ability to work in MRI and OR environments.
Strong communication skills
Exceptional organizational and time management skills.
Ability to work independently when traveling to clinical sites.
A learning mindset, open to becoming an expert across multiple therapeutic areas
Adaptable and flexible, with the ability to adjust to multiple demands and shifting priorities.
Self-motivated with a sound work ethic, initiative, intellectual curiosity, and a desire to acquire new technical skills.
Worksite address
south san francisco, CA, 94083, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.