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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