Director of Clinical Affairs

Xtant Medical Holdings Inc•San Diego, CA

9d•Remote

About The Position

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.

Requirements

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
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)
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

Nice To Haves

Certified Clinical Research Professional (CCRP), Regulatory Affairs Certification (RAC), or clinical research certifications are strongly preferred

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
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
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
Complete all documentation accurately and legibly per GDP, retain records according to Xtant Medical’s procedures, and review others’ documentation as needed
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