Director of Clinical Affairs

Austin, Texas (On-site)          ·        Full time

About the job

The Role

The Clinical Affairs Director will be responsible for the development and execution of clinical study strategies and building the operational team to support human clinical research. The Director will be responsible for study protocol development and lead the cross functional teams supporting this effort. The Director will be heavily involved in FDA submissions pertaining to clinical studies and strategy, including Q-Subs and IDE applications, and would be expected to collaborate directly with FDA alongside Regulatory and Executive Management. This role will plan and execute the clinical study operational requirements, including protocol development, identifying necessary resources (internal/external), site and investigator selection, IRB/ethics requirements, study initiation activities, data collection, monitoring, data analysis and reporting, other required elements of clinical studies under IDE, and budget management. This role will work cross-functionally and collaborate closely with Regulatory, Quality, Product Development, and the Neuroscience teams.

This position is instrumental in supporting the company’s continued growth and future success, and requires an individual with a “can-do,” self-starter attitude who is excited about working collaboratively and diving into hands-on, detailed clinical work in an early-stage medical device company. This individual must be able to step back to view the bigger picture and understand where we are as a company to set priorities, strategy, and direction. This position is based on-site in Austin, Texas and will have less than 5% travel.

Responsibilities include:

• Lead the development and implementation of clinical study strategies, ranging from first in human to pivotal IDE, in close collaboration with Executive Management and external clinician advisors.
• Lead protocol development work encompassing the entirety of a clinical investigation plan, leveraging individual effort coupled with collaboration across internal teams and external resources.
• Lead clinical operations efforts including site and investigator selection, IRB/ethics requirements, study initiation activities, data collection process (including case report form development), monitoring process, data analysis and reporting plans, safety oversight workflows, other required elements of clinical studies under IDE (such as annual reporting), and budget management.
• Establish the clinical operational plan and lead the operational team that will be active in the field during study launch and enrollment/follow-up.
• Identify future workflows and the necessary resource plan to ensure success, including the vetting of potential 3rd parties such as a CRO.
• Directly supporting FDA submissions and FDA engagement in conjunction with Regulatory and Executive Management during the pre-submission process and the IDE submission process.
• Develop clinical study strategies for regions/markets outside the U.S.
• Ensure compliance with applicable regulations and standards, including Good Clinical Practices. This will require creating the necessary SOPs, work instructions, and other tools that are revision controlled and maintained in document control, along with the required training plans for internal and external resources.
• Effectively communicate clinical study requirements and strategies across the organization, from the core project team level to senior management.
• Participate in internal and external audits, as needed.
• Represent the company at various meetings and present/explain clinical study strategies and progress towards goals. This will include internal events and external events.

Required Qualifications

• Bachelor’s degree in an Engineering, Science, or related technical or clinical research field.
• 7-10 years of Clinical Affairs and/or Clinical Research experience in medical device companies, working on behalf of the sponsor. Experience in neurostimulation, neuromodulation, deep brain stimulation, brain computer interface, and other active implantable devices or neural implants is highly desired.
• Extensive experience leading the development and implementation of clinical study strategies, ranging from first in human to pivotal IDE.
• Extensive hands-on experience with protocol development work encompassing the entirety of a clinical investigation plan.
• Extensive hands-on experience with clinical operations efforts including site and investigator selection, IRB/ethics requirements, study initiation activities, data collection process (including case report form development), monitoring process, data analysis and reporting plans, safety oversight workflows, other required elements of clinical studies under IDE (such as annual reporting), and budget management.
• Extensive experience establishing clinical operational plans and leading operational teams that will be active in the field during study launch and enrollment/follow-up.
• Experience identifying future workflows and implementing the necessary resource plans to ensure success, including the vetting of potential 3rd parties such as a CRO.
• Experience directly supporting FDA submissions and FDA engagement during the pre-submission process and IDE submission process.
• Experience developing and implementing clinical study strategies outside the U.S.
• Demonstrated current knowledge of regulations and standards applicable to human clinical research.
• The desire to develop creative solutions to complex problems that meet regulatory requirements and business needs, while sharing knowledge and building consensus amongst stakeholders.
• The desire to thrive in a team environment with a diverse group of people, where individual contributions are highly valued.
• The desire for continuous learning and improvement.
• Excellent communication skills both orally and in written form with a desire for in-person communication. This includes experience leading meetings, projects, and presentations to small and large audiences.
• Excellent organizational skills and the ability to manage competing priorities and plan accordingly.
• Proficient skills with Microsoft Office Suite, Google G-Suite, and other PC based systems.

Preferred Qualifications

• Advanced degree(s) in Engineering, Science, or another related field.
• Experience working directly in the brain-computer interface space or deep brain stimulation including active implantable devices, neural implants, and/or brain-computer interfaces.
• Experience with active electronic medical devices containing software.
• Certification(s) in a clinical affairs or clinical research discipline.

Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Please click here to apply.