Director of Clinical Affairs

Job not on LinkedIn

🕒 June 12

🏄 California, Montana – Remote

🏄 California – Remote 🦬 Montana – Remote

💵 $125k - $175k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Xtant Medical

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

🤝 B2B

💰 $5M Post-IPO Equity - Xtant Medical on 2024-08

Biotechnology • B2B

Xtant Medical is a Montana-headquartered tissue bank and developer of orthobiologics and spinal fixation systems. The company vertically integrates donor recovery, tissue processing, and distribution to provide allografts, biologics (e. g. , viable bone, DBM, allogeneic proteins), synthetic bone grafts, and complementary spinal implants designed to work with their biologic products. Xtant emphasizes clinical performance, traceability, and honoring tissue donation while serving surgeons and healthcare providers with scientifically engineered solutions.

📋 Description

• Lead the company’s clinical affairs initiatives • Involve in all stages of clinical projects, including health care provider engagement around clinical matters • Manage all aspects of clinical studies • Work with health care providers to maintain study progress through closeout and publication • Regularly interact with the Executive leadership team (ELT), R&D, Regulatory, Quality, Marketing, and Commercial teams • Manage a team, ensuring alignment with department goals, providing guidance and mentorship • Oversee performance evaluations and development plans • Coordinate daily workflows, delegating tasks and monitoring performance to ensure efficiency and timely project completion • Engage in staff development through coaching, training and feedback to enhance skills and performance • Develop understanding of relevant industry standards and regulations ensuring compliance across the organization

🎯 Requirements

• Bachelor’s degree (or higher) in life sciences, health sciences, nursing, or related field is required • 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 development • 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 • 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

🏖️ Benefits

• 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