DIRECTOR, CLINICAL AFFAIRS Second Sight Medical Products

The Director of Clinical Affairs, reporting to the VP of Regulatory and Clinical Affairs, supervises in-house and field employees in the Clinical Affairs Department. Responsible to carry out supervisory responsibilities in accordance with the organizations policies and applicable laws. Position Summary: Responsible for the management of internal clinical trials and post-market studies. Essential Duties and Responsibilities: Contributes to company strategic planning with respect to the clinical program. Takes a lead role in the day-to-day management of clinical studies. Ensures that projects are delivered on time, within budget and according to company expectations. Schedules, plans and supervises clinical projects including pre and post- market trials. Provides leadership in the delivery of services to clinical trial sites and subjects. Reviews work produced by clinical project teams. Ensures staff fulfills their responsibilities in accordance with project contracts, policies, procedures and SOPs. Oversee the development, implementation and execution of an electronic data capture system. Provides support to pre-clinical, customer service, QA and R&D project teams. Provides support in the coordination of potential subject recruitment. Supervisory responsibilities include interviewing, hiring and training employees. Must plan, assign and direct work. Responsible for performance appraisal, rewarding and disciplining employees, addressing complaints and problem resolution. Must be able to travel up to 20 of the time for up to 1-2 weeks at a time. Travel may include European locations. Must be willing to adjust work schedule as needed in order to accommodate operations in various time zones. Education/Certification: Graduate degree in a science, clinical or health related field. Experience: Minimum 10 years work related experience as a project manager of clinical trials (both pre- and post-market) with a medical device company. Hands-on experience running all facets of trials in-house (without the use of a CRO) Minimum of 5 years managing professional staff or comparable project management experience. Experience with active implantable or ophthalmic devices a plus. Required Knowledge: Must have a thorough knowledge of the full clinical development process from concept through regulatory approval. Skills/Abilities: Must have excellent written and verbal communication skills and presentation skills. Must be able to motivate teams toward meeting company goals. Some proficiency in French, German or Spanish is a plus. Must be detail-oriented, computer proficient in a Windows environment and possess superior interpersonal and organizational skills.

Location:	Sylmar, CA United States