Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
The Senior Director of Sample Operations will oversee the Sample Operations team within Commercial Operations. This individual will be responsible for leading the strategy and continued development of a comprehensive sample programs complying with the Prescription Drug Marketing Act (PDMA). This will include oversight of the development of written plans, regular audits of operational business functions and implementation of corrective measures where necessary. Candidate shall engage and partner with Senior Leadership to influence decisions and effect implementation of regulatory strategies and considerations in alignment with organization goals.
* Work with key stakeholders to lead the development of new and existing sample programs building a framework for strategic direction and oversight of all direct-to-physician mail programs, ensuring compliance and operational effectiveness.
* Identify solutions that support and enhance the capability to track operational efficiencies and effectiveness of programs; develop and implement new and re-engineered business processes to ensure company's ability to monitor and track activities; analyze trends and lead team to remediate program gaps and issues.
* Direct the team to manage the performance of critical vendors and internal processes to ensure the quality of deliverables, adherence to both internal and external standards and to streamline day-to-day operations and increase efficiency.
* Supervise the development of PDMA compliance training programs and materials as it relates to sample operations. Additionally, monitor, track and analyze the training process for effectiveness and adherence to program business rules to eliminate company exposure.
* Develop and enforce the maintenance of stringent quality control processes and measures that ensure the accuracy of all report information and data extracts.
* Lead alignment efforts with internal departments to develop, implement, and maintain effective processes and documentation.
* Conduct routine internal reviews and audits of vendor activities to ensure ongoing satisfaction based on audit findings and recommend corrective action to ensure action was met.
* Prepare and recommend program operating budgets for approval. Monitor spending for adherence to budget and recommend variances as necessary.
* Develop balanced score cards and Key Performance Indicators to track vendor performance and adherence to statements of work.
* Oversee the development and implementation of standardized sample program work instructions and procedures to ensure compliance with corporate procedures.
* Work with staff to develop objective performance measurements across all sites, to ensure consistent, high-quality evaluation and goal setting for all employees.
* Develop team with respect to capabilities, career paths and self-awareness.