What are the responsibilities and job description for the Director of Clinical Affairs position at Aerin Medical Inc?
Description
We are changing the standard of care for millions of untreated sufferers of ENT conditions. We improve patient access to life-changing relief through safe, practical, and effective innovation that changes how and where patients are served. Aerin differentiates itself with our commitment to providing straightforward and clinically proven products so that ENTs and their patients can make treatment decisions together without limits.
At Aerin Medical, our values show up as : always seeking the collective good, holding ourselves and each other accountable, showing respect with compassion, creation and innovation, and being all in.
As a Director of Clinical Affairs, you will be an essential part of our mission-driven team, dedicated to transforming the lives of those with untreated ENT conditions. Your role will involve contributing directly to our commitment to innovation and improved patient care.
PURPOSE OF THE JOB :
The Director of Clinical Affairs is responsible for implementing the company's clinical plan by leading the clinical operations team, developing and implementing clinical strategies, overseeing trial portfolios, managing large budgets, and ensuring high standards for trial execution. The Director of Clinical Affairs will also represent the clinical research team at executive level meetings. Additional activities include providing clinical input into product development and clinical project management.
MAJOR DUTIES AND RESPONSIBILITIES :
- Contribute to and lead implementation of company's clinical strategies for product indications, labels, publications, etc.
- Oversee the development of clinical protocols with appropriate outcome measures, ensuring alignment throughout the study life cycle (e.g., enrollment, data collection, analysis, and reporting).
- Oversee preparation of compliant and accurate informed consent documents and IRB submission and review processes.
- Oversee identification and selection of appropriate clinical sites for trial participation, negotiating budgets and timing and ultimately driving successful completion of the clinical studies with outcomes that support the strategy of the company.
- Travel to clinical sites, sometimes frequently, to conduct co-monitoring visits, support clinical staff, work with study coordinators, physicians, etc. to monitor and conduct clinical studies.
- Maintain all United States (and other countries, as applicable) related clinical documents, primary responsibility for ensuring complete and compliant trial master files; ensure audit readiness of department.
- Support Marketing, Regulatory Affairs, Quality Assurance, and Engineering departments with appropriate guidance related to clinical studies, strategies, and restrictions.
- Prepare and review clinical documents required for regulatory submissions.
- Review product technical, promotional, and training materials and labeling to ensure accuracy in clinical data cited, provide input and lead clinical study trainings for sales team as needed.
- Represent the clinical affairs leadership in investigator interactions, investigator meetings, and other key opinion leader interactions.
- Responsible for developing and ensuring compliance with department standard operating procedures (SOPs) as well as applicable organization SOPs.
- Responsible for leading clinical team members, including development of individualized career pathways, supporting individual development, and ensuring that each team member is supported to accomplish key goals and milestones.
- Directly responsible for achieving key study-related milestones.
- Provide input into study designs, evidence generation plans, publication and presentation plans, and clinical study reports.
EDUCATION REQUIREMENTS :
EXPERIENCE REQUIREMENTS :
OTHER QUALIFICATIONS :
BENEFITS AND PERKS :
Our culture is rooted in our core values every day, in everything we do. Our benefits focus on the 5 dimensions of wellbeing : physical, financial, emotional, career, and community. Physical benefits include Medical – PPO & HSA with co-contribution, Dental, Vision, Accident Insurance, Critical Illness, Hospital Indemnity, and onsite Tonal & Peloton. Financial benefits include HSA / FSA, 401k with company match, Lifestyle Spending Account, Long Term Disability, Life Insurance, a monthly stipend to cover phone and tech costs, employee discounts, and weekly office lunches. Emotional benefits include Employee Assistance Program, 5 free counseling sessions per issue per year, 80 hours sick leave, 13 holidays, and flexible vacation (exempt employees). Career and Learning & Development opportunities with Aerin led leadership trainings. Community initiatives which include Aerin “give back” week, family days as well as Aerin holiday giving.
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