- 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.
To apply, please visit the careers section of our website: https://lexpharmacareers.silkroad.com/.
For additional information about Lexicon and its programs, please visit www.lexpharma.com.
An Equal Opportunity Employer: race, gender, disability and veteran status
Lexicon Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test, background check and verification of credentials before beginning employment.