[Hiring] Head of Clinical Affairs @InnoTech Staffing

Role Description

InnoTECH Staffing has partnered with an exciting medical device start-up and is looking to hire a fulltime permanent Head of Clinical Affairs. This is a REMOTE position.

We are seeking an experienced and hands-on Head of Clinical Affairs to lead clinical strategy, starting with the execution of our pivotal study. This individual will serve as the clinical leader for the program, providing both strategic oversight and day-to-day operational guidance to ensure successful study execution.

Key Responsibilities

• Clinical Strategy & Leadership
  • Lead the overall clinical strategy, ensuring alignment with regulatory and business objectives.
  • Develop and execute strategies for site selection, enrollment, risk management and data quality.
  • Manage partners and process to facilitate shipment of clinical study products from the US to a clinical site in Sao Paulo, Brazil.
  • Serve as the primary clinical subject matter expert for executive leadership, the Board of Directors, investors, and external stakeholders.
  • Collaborate closely with company team members to support FDA interactions, including pre-submissions, IDE submissions and responses to agency feedback.
• Clinical Study Readiness & Execution Plan
  • Develop and execute a plan to demonstrate the Company’s enrollment targets are achievable within the timeframe budgeted for in the operating plan.
  • Manage preparation of clinical study infrastructure, operational controls, and vendor (CRO, EDC, TMF) selection and management.
  • Lead process for clinical site readiness, including finalizing site budgets, contracts, IRB approvals, site qualifications and site initiation visits.
  • Partner with clinical sites to develop a robust site specific patient recruitment plan to achieve their enrollment targets.
  • Identify operational risks and implement mitigation plans to ensure study success.
• Clinical Operations Oversight
  • Oversee the execution of the IDE clinical study, ensuring milestones, timelines, enrollment targets, and budgets are achieved.
  • Monitor study progress, enrollment, data quality, protocol compliance, site performance, and patient retention.
  • Ensure that clinical investigation strictly adheres to GCP guidelines and ISO 14155.
  • Partner with investigators and clinical sites to support successful study conduct and participant recruitment.
  • Assist with preparation of clinical materials for regulatory submissions, investor presentations, scientific publications, and conference presentations.

Qualifications

• 10+ years of clinical study execution & submission experience in the medical device industry.
• Demonstrated experience leading FDA IDE pivotal clinical studies through execution.
• Deep understanding of FDA regulations governing medical device clinical trials, including IDE requirements, Good Clinical Practice (GCP), and ISO 14155.
• Experience managing CROs and external clinical vendors.
• Strong knowledge of clinical study design, execution, monitoring and data management.
• Excellent leadership, communication, and stakeholder management skills.
• Ability to operate effectively in a fast-paced startup environment with limited resources.
• Experience implementing clinical SOPs.

Personal Attributes

• Strategic thinker who is also willing to engage in day-to-day operational execution.
• Highly organized with strong project management capabilities.
• Collaborative and team-oriented leadership style.
• Comfortable navigating ambiguity and helping build processes from the ground up.
• Strong sense of accountability and ownership.

Compensation

• Competitive salary, benefits and equity commensurate with experience.