Director / Senior Manager, Pharmacy - Clinical Research Unit, Madison, WI
We're seeking an experienced pharmacy leader to join our team in Madison, WI, where you will play a vital role in advancing early-phase clinical research. As the Director/Senior Manager of Pharmacy, you'll oversee the Madison pharmacy operations that support innovative clinical trials-leading a talented team, ensuring high-quality investigational product preparation, and shaping pharmacy strategy from study design through execution.
The Madison Pharmacy operates within a cGMP environment and plays a critical role in ensuring safe, compliant, and uninterrupted investigational product preparation and release. This on-site leadership role provides direct oversight of cleanroom operations, staff competency, adherence to USP <797>, <795>, and <800>, and close coordination with Clinical Operations to meet protocol-driven dosing timelines. Your presence is essential to maintaining inspection readiness, supporting participant safety, and ensuring consistent and high-quality trial delivery at the site.
In this senior position, you will serve as the organization's primary pharmaceutical expert-guiding feasibility assessments, regulatory compliance, quality initiatives, and operational excellence. If you're passionate about leading high-performing teams and contributing to breakthrough research, we encourage you to apply and explore this opportunity with us.
What You'll Do
- Provide strategic direction for the pharmacy function and ensure alignment with organizational goals.
- Serve as the lead pharmacist on clinical trials, advising on pharmaceutical aspects from protocol design through study completion.
- Oversee staffing, workflow management, hiring, training, performance, and professional development for the pharmacy team.
- Ensure compliant preparation, storage, and dispensing of investigational products; maintain facilities to required standards.
- Lead SOP development, quality systems, audits, and continuous improvement initiatives.
- Partner with clients, sponsors, and internal teams; participate in protocol development, feasibility assessments, and sponsor visits.
- Review new proposals and support global pharmacy metrics and reporting.
- Interact with regulatory bodies as needed and ensure strict adherence to safety and GxP requirements.
- Perform dispensing functions as needed.
What You Bring
- Registered Pharmacist/PharmD with appropriate state licensure, or Non-pharmacist Manager/Director with clean room experience (ISO 7/8 environment) and demonstrated management experience.
- 10+ years of pharmacy experience, including 5+ years in clinical research and 2-5 years in leadership roles.
- Experience overseeing pharmacy operations, staff, and quality systems.
- Equivalent relevant experience may be considered in place of formal education.
Work Environment:
- 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.
Physical Requirements:
- Ability to work in an upright and /or stationary position for 10-12 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.
The important thing for us is you are comfortable working in an environment that is:
- Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
- Changing priorities constantly asking you to prioritize and adapt on the spot.
- Teamwork and people skills are essential for the study to run smoothly.
- Technology based. We collect our data directly into an electronic environment.
What do you get?
Regular, full-time, or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:
- Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
- 401(K)
- Paid time off (PTO)
- Employee recognition awards
- Multiple ERG's (employee resource groups)
Learn more about our EEO & Accommodations request here.