Position: We are seeking an experienced manager who will lead the planning and execution of Scion’s clinical studies. A planned Parkinson’s disease RCT, called STEM-PD, will be the first focus in our development program. She or he will ensure that the Company’s clinical trials, products and services comply with all national laws and regulations that may govern them. The successful candidate will represent the Company before regulatory boards and outside reviewers and auditors.
Contribute to the development and implementation of pre-clinical, clinical, manufacturing, and regulatory strategy for projects in all stages of development.
He or she will promote adherence to Quality Systems regulations throughout the Company. Ensure implementation and enforcement of policies and procedures of the organization by way of systems that will improve the overall operation and effectiveness of the corporation and ensure the policies and procedures fully conform to current laws and regulations. Ensure quality and regulatory compliance of contract manufacturing and operations.
Serve as a primary liaison to the FDA and notified bodies.
Work with the Scion team and consultants to prepare submissions to the FDA and for CE marking.
Establish and deliver training programs and awareness training for other associates who interact with or impact Scion’s products.
A post-baccalaureate degree with at least 5-8 years of experience or a bachelor’s degree and 10+ years of experience.Regulatory Affairs Certification (RAC) required
Demonstrated management and leadership experience in the conduct of multi-site clinical trials.
Excellent project management skills across multiple teams.
Scion Neurostim has created a non-invasive neuromodulation device TNM for treating a range of neurological diseases. TNM has been cleared for the treatment of episodic migraine headache. Other indications for use, including Parkinson's disease and Alzheimer's disease, are under development. Scion is located in the RTP region of North Carolina