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

Were seeking an experienced pharmacy leader to join our team in Madison WI where you will play a vital role in advancing earlyphase clinical research. As the Director/Senior Manager of Pharmacy youll oversee the Madison pharmacy operations that support innovative clinical trialsleading a talented team ensuring highquality 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 onsite 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 protocoldriven dosing timelines. Your presence is essential to maintaining inspection readiness supporting participant safety and ensuring consistent and highquality trial delivery at the site.

In this senior position you will serve as the organizations primary pharmaceutical expertguiding feasibility assessments regulatory compliance quality initiatives and operational excellence. If youre passionate about leading highperforming teams and contributing to breakthrough research we encourage you to apply and explore this opportunity with us.

What Youll 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 25 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 ERGs (employee resource groups)

Learn more about our EEO & Accommodations request here.