Director / Senior Manager, Pharmacy - Clinical Research Unit, Madison, WI
Fortrea
Clinical Trials Director / Senior Pharmacy Manager What if your pharmacy leadership helped new medicines take their first step in human clinical trials? Fortrea, is one of the world's leading early phase research organizations, delivering first-in-human and early development studies across a global network. Our Madison, WI Clinical Research Unit brings together clinic and cGMP pharmacy under one roof-offering a modern, integrated environment supported by experienced teams, strong academic partnerships, and access to diverse patient populations. If Madison is where new medicines begin their journey, this role exists to lead the pharmacy function that makes that possible. As our next Clinical Trials Director / Senior Pharmacy Manager , you will combine strategic leadership with hands-on operational expertise, leading teams that prepare and deliver investigational medicinal products (IMP) during live clinical trials. This is a full-time, on-site role in Madison, WI. WHY IS THIS ROLE DIFFERENT? This is a rare opportunity to lead pharmacy operations at the front line of first-in-human research. At Fortrea Madison:
- Pharmacy, clinic, and quality operate side-by-side in real time.
- You lead teams preparing IMPs just steps away from dosing.
- Your decisions directly impact patient safety and study outcomes.
- Manage Pharmacists and Pharmacy Technicians with clear expectations and standards.
- Recruit, onboard, and develop talent as the function grows.
- Foster a culture of accountability, collaboration, and excellence.
- Plan and oversee daily operations supporting active trials.
- Ensure readiness for early morning dosing and fast-paced execution.
- Maintain control and consistency in a dynamic environment.
- Apply and expand expertise in clean room pharmacy operations.
- Step into operations as needed to support continuity.
- Lead from the front during complex or time-critical activities.
- Own compliance in GMP-aligned, regulated environments.
- Oversee clean room standards, equipment, and environmental controls.
- Support inspections and audits in collaboration with Quality teams.
- Ensure accurate preparation of investigational products.
- Support teams operating at the highest level of clinical risk.
- Make decisions that directly impact participant safety.
- Registered Pharmacist (PharmD) with active state license.
- We will also consider a Pharmacist with strong management/leadership experience, even if coming from non-clinical research settings, provided there is transferable operational expertise.
- Demonstrated experience leading, developing, and managing teams.
- Background in regulated pharmacy, healthcare, or production environments.
- Ability to scale operations and lead through growth.
- Experience in clean room or controlled production environments (hospital, infusion, institutional, or research).
- Strong understanding of sterile handling, contamination control, and operational discipline.
- Ability to operate in highly regulated, quality-driven environments.
- Experience with USP <797> and USP <800> standards.
- Clean room / sterile compounding background.
- GMP and/or clinical research (Phase I) experience.
- Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
- Occasional drives to site locations, occasional domestic travel.
- Exposure to biological fluids.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
Vacancy posted 1 day ago
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