Director Clinical Pharmacy

QPS, LLC•Springfield, MO

7h•Onsite

About The Position

The Director, Clinical Pharmacy works in conjunction with the Vice President and Principal Investigators to execute clinical trials in adherence to FDA/ICH and other state and local regulations following Good Clinical Practice standards while conducting clinical research trials. This key leadership position requires a seasoned professional with a deep understanding of USP guidelines, and FDA requirements, and a thorough knowledge of the regulatory landscape in clinical trials. The Director, Clinical Pharmacy will be responsible for ensuring compliance, implementing best practices, and contributing to the advancement of pharmaceutical services within the organization. The Director, Clinical Pharmacy will be responsible to report any noncompliance issues to Vice President, Clinical Operations, and Investigators as soon as noticed.

Requirements

Ten years or more of related experience, preferably in a clinical environment.
Previous experience in any of the following: protocol development, clinical conduct of a study, report writing, project management, or pharmacokinetics.
Strong knowledge of FDA/GCP/ICH guidelines.
Certification / Licensure: State Registered Pharmacist

Nice To Haves

Clinical research experience

Responsibilities

Stay abreast of evolving USP guidelines, FDA requirements, and other relevant regulatory standards.
Advise on drug development strategies, including formulation, stability, and regulatory submissions.
Ongoing review, maintenance, and approval of established Standard Operating Procedures (SOPs) related to pharmaceutical services.
Potential of implementing SOPs to meet GMP standards to allow for encapsulation, labeling, etc. in accordance with Sponsor direction and regulatory guidelines.
Potential of preparing complex compounding drugs in a fully functional USP797 pharmacy
In depth knowledge, understanding and execution of randomization used for each study, including being responsible for ensuring study specific randomization is followed when dispensing and transferring study medication for each IP administration for each study.
Represent the pharmaceutical services department in cross-functional meetings and communicate effectively with stakeholders.
Collaborate with external partners, including sponsors and regulatory agencies, to enhance the center's reputation and capabilities.
Provide regular budget updates, forecasting future needs and identifying areas for optimization.
Oversee relationships with pharmaceutical vendors, negotiating contracts, and ensuring compliance with service level agreements.
Executes clinical research trials in strict compliance with study protocol, standards of Good Clinical Practice, ICH guidelines, Standard operating procedures, QA/QC procedures, OSHA guidelines, Food and Drug Administration (FDA) guidelines, and other state and local regulations where applicable.
Participate in sponsor Investigator's meetings which may require travel off-site.
Recruits, leads, and supervises the Pharmaceutical Services staff, work closely with the Clinical Research Coordinators and other delegated pharmacy staff members.