Job Description
Are you passionate about transforming healthcare and making a real difference in people's lives? We're on a mission to improve the quality of life for those with chronic respiratory diseases. With our first product now FDA-approved and our innovative pipeline in development, we're dedicated to providing relief for patients with conditions like COPD, cystic fibrosis, and asthma.
Join our dynamic team and be a part of our journey to challenge the status quo in drug development. We offer a supportive and inclusive work environment where your contributions make a significant impact. If you're ready to shape the future of clinical supply chains, we want to hear from you!
What You'll Do:
Lead Clinical Supply Planning: Oversee the strategic planning and execution of clinical supply chains for global studies. Ensure timely manufacturing, packaging, labeling, and distribution of clinical supplies.
Collaborate Across Teams: Work closely with Clinical Operations, Regulatory Affairs, and Quality Assurance teams to align on study protocols, distribution strategies, and supply needs.
Manage Supply Chain Projects: Handle procurement, inventory management, and vendor oversight. Ensure smooth execution of cross-functional plans and address any vendor performance issues.
Forecast and Plan: Develop accurate forecasts and contingency plans to meet clinical study requirements, and present these to senior management.
Ensure Compliance: Maintain adherence to internal procedures and GXP requirements. Serve as a subject matter expert for Interactive Response Technology (IRT) and ensure compliance throughout the study.
Risk Management: Identify potential supply risks and implement corrective actions to ensure uninterrupted supply.
Contribute to Regulatory Submissions: Author key documents and responses for regulatory submissions and represent the company at global investigator meetings.
What You'll Need:
Experience: 10+ years in Clinical Supply Chain Management within pharmaceutical or biotech industries, with extensive experience in clinical forecasting and supply chain networks.
Skills: Strong understanding of GXP, GMP/GCP, and clinical regulations. Excellent problem-solving skills, with the ability to develop creative solutions for complex supply chain issues.
Education: Bachelor's degree in science or business (preferred). A Master's degree is a plus.
Flexibility: Ability to adapt to changing schedules and project demands. Willingness to travel 10-15% both domestically and internationally.
Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project). Experience with IRT systems is highly desirable.
Why Join Us?
Impactful Work: Be a part of a team dedicated to improving lives through innovative respiratory treatments.
Flexible Environment: Enjoy the flexibility of remote work with occasional office visits in Raleigh, NC.
Competitive Benefits: We offer generous paid time off and other benefits to support your well-being and work-life balance.
Inclusive Culture: Work in a diverse, supportive environment where your contributions are valued and make a real difference.
Ready to lead the way in clinical supply chain management? Apply now and help us shape the future of respiratory healthcare!
Employment Type: Full-Time
Salary: $ 77,800.00 Per Year
Job Tags
Full time, Relief, Remote job, Flexible hours,