Job Description
The Senior Manager, Pharmacy Support Services (PSS) serves as a highimpact subject matter expert in investigational product (IP) management and pharmacy operations across our clinical portfolio. In this role, you will guide best practices for IP handling, preparation, and administration; develop highquality pharmacy documentation and training; and support global clinical sites to ensure safe, compliant, and streamlined trial execution. You will partner closely with Formulation Development Group (FDG), Clinical Operations, and CDSL leadership to shape strategy, improve processes, and directly influence the success of our trials. This is an opportunity to elevate your clinical and scientific expertise in a role that blends technical depth, operational leadership, and crossfunctional collaboration. A Typical Day In This Role Looks Like Lead Pharmacy & Clinical Trial Support Act as the primary SME on investigational product preparation, administration, blinding, and pharmacyrelated ancillary supplies. Shape the development of pharmacy manuals, clinical study documents, and training materials supporting biologics and gene therapy programs. Partner with Clinical Operations, CROs, and site pharmacy teams to ensure IP readiness, compliance with regulatory requirements, and optimal preparation workflows. Drive Study Execution Excellence Lead or contribute to KickOff Meetings, Site Initiation Visits, Investigator Meetings, and IPfocused training for global clinical teams. Support the review and resolution of IPrelated deviations and practicebased issues to maintain protocol integrity and patient safety. Manage ancillary supply compatibility assessments in collaboration with FDG. Uphold Quality, Compliance & Continuous Improvement Provide guidance on IPrelated quality assurance issues and support risk mitigation strategies. Ensure adherence to GCP, ICH guidelines, and federal/international regulatory standards. Identify opportunities to enhance processes and elevate site experience through datadriven improvements and feedback mechanisms. Develop & Mentor Talent Create engaging training modules for internal teams, monitors, and research sites. Play a key role in onboarding new colleagues and fostering a culture of scientific excellence, collaboration, and shared knowledge. This Role May Be For You If You Have - Expertise in sterile product preparation and infusionbased drug administration Experience with biologics; cell and gene therapy exposure preferred Strong understanding of clinical supply chains and clinical trial execution Exceptional communication, documentation, and presentation skills Ability to manage complex projects and influence crossfunctional teams Adaptability, critical thinking, and a continuousimprovement mindset Familiarity with PCAB, FDA, USP /, NABP/VPP, and EU CTR guidelines- Strong analytical, decisionmaking, and problemsolving capabilities In order to be considered qualified , a minimum of a bachelors degree in pharmacy or nursing with 8+ years of experience in hospital pharmacy, clinical research, or pharma/biotech. Or a PharmD with 6+ years of experience in hospital pharmacy, clinical research, or pharma/biotech. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other countries specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, a