Job DetailsLevel SeniorPosition Type Full TimeEducation Level 4 Year DegreeSalary Range $110.00 - $170.00 Salary/yearTravel Percentage Up to 25%Job Shift DayDirector of Clinical Affairs
This role requires a results-oriented self-starter with leadership skills that demonstrates abilities to collaborate in a cross-functional environment and adapt quickly. The individual must have a commercial strategic mindset, leveraging clinical trial relationships for future commercial success including KOL engagement, engagement with therapeutically relevant organizations, or otherwise.
Zynex Offers Exceptional Benefits (Full-Time Roles): Premium starting pay Health, dental, & vision insurance 401k with company contribution 8 paid holidays + up to 2 additional floating holidays (1 every 6 months) 3 weeks Paid Time Off (PTO) for sick or vacation time; increases to 4 weeks after 2 years with the company Annual LinkedIn Learning subscription to facilitate employee skill and competency development Health & wellness bonus up to $50/month Frequent opportunities for role transitions and advancements Weekly employee appreciation activities/perks Up to $75/month reimbursement for community volunteer hours Employee product discounts
Essential Job Duties and Responsibilities: Leads the development of the current clinical landscape, competitive analyses, developing the clinical evidence strategies to best position the company for successful regulatory approvals and commercialization Designs and lead execution of clinical studies for regulatory submissions, reimbursement, and market adoption, including clinical study documents (protocol, case report forms, investigator brochures, clinical study reports, etc.), study implementation and data reporting activities. Foster and maintain strong relationships through direct interactions with medical advisors, clinical leaders and study investigators and their staff. Responsible for contract and budget negotiations with hospitals, consultants, investigators, CROs, database management firms and outside vendors. Responsible for administrative activities associated with the clinical department including procedures (SOPs), training of key personnel and preparation and maintenance of objectives and budgets. Oversees and completes clinical data analysis and review. Creates the publication strategy, leads abstract and manuscript writing and submission activities as well as training efforts to understand and interpret available clinical evidence Contributes to writing and review of clinical documents in regulatory agency submissions (IDE, PMA, MDR, etc). Partners with cross-functional team members to meet business objectives. Leadership of internal clinical research and medical science liaison teams and CROs to deliver on business objectives. Ensures that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices. Implements best practices and standards for trial management in collaboration with other members of the team Lead initiatives to build departmental infrastructure. Other duties as assigned.
Minimum Job Qualifications: Bachelor’s degree in a Life Sciences or Equivalent field (Masters Preferred). Minimum of 5-8 years of clinical trial leadership experience, with 3+ years of managerial experience, in a medical device environment, including global experience.
Relevant Experience: Minimum of 5 years of clinical trial leadership experience, with 3+ years of managerial experience, in a medical device environment, including global experience. Experience managing CROs and vendors throughout entire clinical trial life cycle Understands biostatistical concepts and is adept at reviewing data analyses Proven success participating in cross-departmental (senior management, regulatory, engineering, QA, program management, finance, business development, scientific affairs, medical writing) clinical strategy, planning and implementation activities Proven success in leading and coordinating cross-functional clinical trial teams (e.g., clinical operations, data management, biostats, clinical supply chain) Direct experience with sponsor, site, and/or vendor preparation for and participation in regulatory inspections, with global experience preferred Experience with employee development (e.g. coaching, mentoring), talent acquisition, performance management, conflict resolution and providing work direction to teams Excellent working knowledge of FDA regulations and expectations, Good Clinical Practice, ICH guidelines and clinical operations best practices U.S. FDA Pre-Market Application (PMA) and 510(k) experience as well as knowledge of EU MDR Knowledge of electronic data capture systems and web-based clinical trial management tools In-depth understanding of common medical device product development processes / requirements Change agent and collaborative team player Ability to travel 25% of the time
Note: This job description is not intended to be an exhaustive list of all duties, responsibilities or qualifications associated with the job.
**Employees are held accountable for all duties of this job**
Zynex Medical is an Equal Opportunity/Affirmative Action employer
- Business Development
- Business Planning
- Case Report Forms
- Clinical Research
- Clinical Study Reports