Director / Senior Manager, Pharmacy - Clinical Research Unit, Madison, WI

Fortrea•Madison, WI

3d•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

Equivalent relevant experience may be considered in place of formal education.

Responsibilities

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.