Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science, based on Nobel Prize-winning technology, to discover and develop precise medicines for patients with serious, chronic conditions.
Our world class research and commercialization teams are located in Basking Ridge, New Jersey and The Woodlands, Texas. Lexicon employees are inspired by the idea that their work can improve patients' lives and we know that our employees are important to the success of our mission. We are dedicated to making Lexicon a great place to work by providing employees with the benefits, services, and programs which will allow them to reach their full potential.
Lexicon Pharmaceuticals is currently recruiting for an agile, resulted focused Associate Director/Director of Clinical Quality Management to join our team in Basking Ridge, New Jersey.
The Associate Director/Director of Clinical Quality Management will lead the development and implementation of a quality management function within Clinical Operations. This position will work closely with Clinical Operations and Clinical Quality Assurance team members to ensure the highest possible levels of compliance with company SOPs and applicable guidance and regulations through process evaluation and improvement, training of staff, development and reporting of quality metrics, direct evaluation of department and vendor work product, and assisting in remediation efforts.
Key Responsibilities include but will not be limited to:
- Monitoring performance of Clinical Operations relative to applicable Policies, SOPs, Work Practices and Study Plans to evaluate compliance. Working with department leaders to plan and execute preventative and remediation activities to correct any gaps.
- Serving as a Clinical Operations subject matter expert (SME) on matters of clinical quality to ensure “inspection readiness” of the Clinical Operations function and its vendors/CROs as required.
- Spearheading continuous improvement activities to implement best practices and enhance compliance.
- Overseeing development and implementation of Clinical Operations SOPs
- Assisting in selection of clinical operations vendors, monitoring their performance and resolving quality and performance issues.