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.
Master’s degree in Regulatory, Public Health, Healthcare Management or other applicable field
Certification by an industry organization for Clinical Research (e.g., ACRP, SOCRA) and as a Clinical Quality Auditor are highly desirable
Minimum of 10 years in pharmaceutical drug development clinical operations roles, including leadership roles in project management and/or monitoring, and at least 3 years in clinical quality-related roles.
At least 5 years of experience in working with and overseeing vendors including CROs.
Expert knowledge of GCP/ICH and the necessary elements of a compliant quality system in clinical research.
Experience in writing and implementing SOPs, Work Instructions, and associated forms and templates.
Proven track record of exercising sound and independent judgment in methods, techniques and evaluation criteria in the area of clinical research, including application of risk management principles.
Experience in identifying and successfully implementing opportunities for process improvement and of leading continuous improvement initiatives.
Ability to effectively work within a small matrixed organization.
Demonstrated ability to be flexible and find “win-win” solutions that accomplish the company’s goals without sacrificing core quality principles.
Strong leadership and project management skills.
High degree of self-motivation, detail-orientation
Highly effective written and oral communication skills.
Willingness and ability to travel up to 40% of the time to investigator sites, the Lexicon site in The Woodlands Texas, to vendors, and clinical sites.
Experience in supporting Sponsor, CROs and/or sites during health authority inspections (FDA, EMA, MHRC)
Experience in supporting the selection, implementation and validation of validated systems for clinical trial data and documentation.
Experience in designing and delivering quality systems training
Understanding of regulatory requirements for validated systems for clinical trial data and documentation management.
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.
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