Classification: Full Time, Exempt

Reports to: Senior Vice President of R&D and Project Management

1. Job Summary

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, and 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.

1. Supervisory Responsibilities
   • This position may manage others/a team, ensuring alignment with department goals, providing guidance and mentorship, and overseeing performance evaluations and development plans. The role involves coordinating daily workflows, delegating tasks, and monitoring performance to ensure efficiency and timely project completion
   • Actively engage in staff development through coaching, training and feedback to enhance skills and performance, while leading team meetings to ensure clear communication and drive project/production success, all while ensuring adherence to company policies, procedures, and quality standards
   • Develop department team goals that are fully aligned with the company goals
   • Assist in the hiring of skilled, responsible, and ethical individuals for the company
   • Review and approve PTO requests for employees within department, as applicable
   • Administer performance reviews and corrective action plans as necessary, ensuring fairness, effectiveness, and compliance with Xtant’s performance review program
2. Duties and Responsibilities
   • Develop and maintain an understanding of relevant industry standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485, ensuring compliance with these requirements across the organization.
   • Actively contribute to the fulfillment of Xtant Medical’s mission, values and quality policy
   • Maintain a safe, clean work environment and ensure proper disposal of hazardous and non-hazardous waste according to OSHA guidelines and Xtant Medical standard operating procedures (SOP)
   • Develop and maintain an understanding of Xtant Medical products
   • Understand the interaction of departmental activities with the Quality System and their impact on the production of medical devices and human cells, tissues, and cellular and tissue-based products (HCT/Ps)
   • Adhere to Xtant Medical SOPs, Good Documentation Practices (GDP), and safety protocols
   • Implement and maintain processes for all aspects of clinical studies
   • Work closely with the R&D, Marketing, and Regulatory teams to determine beneficial studies to guide product development initiatives, obtain device approvals, support product marketing claims, develop product publications, and drive reimbursement objectives
   • Lead the creation/maintenance of clinical documents (e.g., protocols, study plans, study training materials, and study reports)
   • Coordinate all aspects of clinical studies, including identification of candidate sites, initiating discussions with potential investigators, conducting pre-qualification visits, meeting with clinicians to maintain engagement, completing routine monitoring visits, and finalizing site closures
   • Coordinate and participate in the review and approval of clinical white papers
   • Maintain expertise of relevant company and competitive product clinical publications to support Product Development and Risk Management activities
   • Offer clinical expertise and product support to further the progress of clinical initiatives
   • Identify, contract, and manage clinical study vendor(s), as needed
   • Manage Investigator and Advisory Board meetings
   • Ensure compliance with appropriate regulatory (FDA, IRB, etc.) and internal guidelines
   • Other duties as assigned
3. Financial Responsibilities
   • Submit timely expense reports and abide by the Expense Reimbursement Policy
   • Prepare budget estimates for potential studies
   • Maintain proper accounting for study expenses
   • Approve, as necessary, payment of study related expenses
   • Ensure adequate control and safeguarding of materials for site distribution
4. Training
   • Write, review, and revise a variety of technical documents including Standard Operating Procedures), specifications, and training documents.
   • Legibly and accurately complete all documentation associated with assigned duties
   • Complete required training, including but not limited to initial orientation and environmental health and safety training prior to performing tasks
   • Participate in training programs, ensuring timely completion and accurate, up-to-date training records
   • Complete annual SOP review and safety training as applicable
   • May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
5. Document Control and Record Control
   • Complete all documentation accurately and legibly per GDP, retain records according to Xtant Medical’s procedures, and review others’ documentation as needed
6. Performance of Duties
   • Perform duties and responsibilities to the highest standards with efficiency, professionalism, and attention to detail; adapt to job changes and contribute to team success
   • Maintain confidentiality of donor and recipient information according to HIPAA
7. Required Skills/Abilities
   • Must possess high level leadership and management skills, with the ability to motivate and inspire teams
   • Excellent communication and presentation skills required
   • 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, with the ability to collaborate effectively with health care providers and cross-functional teams
   • Ability to work in a fast-paced, dynamic environment with changing priorities
   • Strong attention to detail and ability to manage multiple projects simultaneously
   • Efficiently organizes and prioritizes work within a multifaceted framework and set deadlines
   • Demonstrated ability to train, cross train, direct, and mentor others
8. Education & Experience
   • Bachelor’s degree (or higher) in life sciences, health sciences, nursing, or related field is required. (Will substitute an Associate’s degree with advanced degree or MBA)
   • Certified Clinical Research Professional (CCRP), Regulatory Affairs Certification (RAC), or clinical research certifications are strongly preferred
   • Minimum of seven (7) years’ experience in clinical practice, clinical operations, clinical research, or clinical study developent.
   • Minimum of five (5) years in clinical leadership or management with oversight of clinical staff, multidisciplinary teams, budget and resource planning
   • Hands on experience designing, managing, or overseeing clinical trials and clinical studies (early feasibility through post-market), clinical evidence generation strategies, protocol development, CRFs and study reports.
   • Demonstrated responsibility for clinical trial execution, site selection, investigator engagement and KOL relationships.
   • Proven experience with managing budgets, timelines, and resourcing.
   • Tissue and biologics, including biologic device experience is required
   • Strong working knowledge of global regulations related to clinical trials
   • Strong understanding of how clinical data supports product development, market access, label expansion and lifecycle management
   • Experience in conducting performance reviews and issuing performance correction notices, as necessary
9. Working Conditions
   • This position is primarily based in an office environment
   • Standard work hours are Monday – Friday; 8:00 am – 5:00 pm, with occasional overtime or weekend work based on project/production needs
   • Work will require periodic travel, domestically. The amount of travel will vary depending on business needs, with an estimated 75% of the time spent on travel
   • This position is U.S. remote based, with flexible hours available based on department needs
   • This position may sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves, etc.
   • Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver
10. Physical Requirements
    • Ability to sit, stand, and work at a computer for prolonged periods
    • Ability to lift, carry, push or pull items of varying weight, typically up to 50 lbs.
    • Requires hand-eye coordination and manual dexterity for tasks such as typing
    • Ability to see clearly, whether with or without corrective lenses
    • Ability to hear and understand safety signals, alarms, and customer requests in a noisy environment
    • Ability to safely operate a motor vehicle, including cars, trucks, or commercial vehicles, as required by the position. This includes the ability to drive for extended periods, in various weather conditions, and on different road types (urban, rural, highways, etc.)

Note: This Job Description is not designed to include a detailed listing of the activities, duties or responsibilities that may be required of the employee. This job description does not constitute an employment contract, implied or otherwise, and is subject to change by the employer as the needs of the employer and requirements of the job change.

Xtant Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.