Xtant Medical Holdings Inc

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Director of Clinical Affairs leads the company’s clinical affairs initiatives. This position will be involved in all stages of clinical projects, including: - Health care provider engagement around clinical matters - Managing all aspects of clinical studies - Working with health care providers to maintain study progress through closeout and publication This position regularly interacts with the Executive leadership team (ELT), R&D, Regulatory, Quality, Marketing, and Commercial teams. Supervisory Responsibilities - Manage a team, ensuring alignment with department goals - Provide guidance and mentorship - Oversee performance evaluations and development plans - Coordinate daily workflows and delegate tasks - Monitor performance to ensure efficiency and timely project completion - Engage in staff development through coaching, training, and feedback - Lead team meetings to ensure clear communication and drive project success - Develop department team goals aligned with company goals - Assist in hiring skilled individuals - Review and approve PTO requests - Administer performance reviews and corrective action plans Duties and Responsibilities - Develop and maintain understanding of relevant industry standards and regulations (e.g., 21 CFR 820, 21 CFR 1271, AATB, MDSAP, ISO 13485) - Contribute to the fulfillment of Xtant Medical’s mission, values, and quality policy - Maintain a safe, clean work environment and ensure proper waste disposal - Develop and maintain understanding of Xtant Medical products - Understand interaction of departmental activities with the Quality System - Adhere to Xtant Medical SOPs, Good Documentation Practices (GDP), and safety protocols - Implement and maintain processes for clinical studies - Work closely with R&D, Marketing, and Regulatory teams - Lead creation/maintenance of clinical documents (protocols, study plans, training materials, reports) - Coordinate all aspects of clinical studies - Coordinate and participate in review and approval of clinical white papers - Maintain expertise of relevant clinical publications - Offer clinical expertise and product support - Identify, contract, and manage clinical study vendors - Manage Investigator and Advisory Board meetings - Ensure compliance with regulatory and internal guidelines - Other duties as assigned Financial Responsibilities - Submit timely expense reports - Prepare budget estimates for potential studies - Maintain proper accounting for study expenses - Approve payment of study-related expenses - Ensure adequate control and safeguarding of materials for site distribution Training - Write, review, and revise technical documents - Complete all documentation accurately - Complete required training - Participate in training programs - Complete annual SOP review and safety training - May require OSHA training and other safety training Document Control and Record Control - Complete all documentation accurately per GDP - Retain records according to Xtant Medical’s procedures - Review others’ documentation as needed Performance of Duties - Perform duties to the highest standards with efficiency and professionalism - Maintain confidentiality of donor and recipient information according to HIPAA Required Skills/Abilities - High level leadership and management skills - Excellent communication and presentation skills - Strategic thinking and clinical decision-making - Ability to translate clinical data into business decisions - High ethical standards and patient-centric mindset - Risk management and problem solving in complex clinical environments - Vendor and stakeholder management - Strong understanding of clinical data interpretation and publication strategy - Strong interpersonal skills - Ability to work in a fast-paced, dynamic environment - Strong attention to detail and ability to manage multiple projects - Efficiently organize and prioritize work - Demonstrated ability to train and mentor others Education & Experience - Bachelor’s degree (or higher) in life sciences, health sciences, nursing, or related field required - Certified Clinical Research Professional (CCRP), Regulatory Affairs Certification (RAC), or clinical research certifications preferred - Minimum of seven (7) years’ experience in clinical practice, clinical operations, or clinical research - Minimum of five (5) years in clinical leadership or management - Hands-on experience designing, managing, or overseeing clinical trials - Demonstrated responsibility for clinical trial execution and site selection - Proven experience with managing budgets, timelines, and resourcing - Tissue and biologics experience required - Strong working knowledge of global regulations related to clinical trials - Experience in conducting performance reviews and issuing performance correction notices Working Conditions - Primarily based in an office environment - Standard work hours: Monday – Friday; 8:00 am – 5:00 pm - Occasional overtime or weekend work based on project needs - Periodic travel, domestically (estimated 75% of the time) - U.S. remote based, with flexible hours available - May require wearing personal protective equipment (PPE) - Hepatitis B vaccine is highly recommended Physical Requirements - Ability to sit, stand, and work at a computer for prolonged periods - Ability to lift, carry, push or pull items up to 50 lbs. - Requires hand-eye coordination and manual dexterity - Ability to see clearly, with or without corrective lenses - Ability to hear and understand safety signals and customer requests - Ability to safely operate a motor vehicle as required