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Classification: Full Time, Exempt

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

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.

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

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

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

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

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

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

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

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

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

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.

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