Clinical Specialist, Translational Medicine (Onsite, South San Francisco - Bay Area)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
- 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.
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.
