Clinical Pharmacist

Description Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Stage Clinical and Phase I IV Clinical Research services. QPS welcomes individuals who want to be part of our growing organization. It is an innovative, dynamic organization that strives to employ talented, caring and committed employees who work collaboratively towards improving human health and the quality of life. QPS offers challenging and rewarding work across its four core business areas and support functions, underpinned by a culture that values diversity, innovation and accountability. Employees are encouraged to take responsibility and achieve their best, both as individuals and as team members. The Clinical Pharmacist 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 professional with an understanding of USP guidelines, FDA requirements, and an expertise in ensuring compliance, implementing best practices, and contributing to the advancement of pharmaceutical services within the organization. The Clinical Pharmacist will report any noncompliance issues to the Vice President of Clinical Operations and Investigators as soon as noticed. 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 SOPs related to pharmaceutical services. Implement SOPs to meet GMP standards for encapsulation, labeling, etc. in accordance with sponsor direction and regulatory guidelines. Prepare complex compounding drugs in a fully functional USP797 pharmacy. Execute randomization protocols for each study, ensuring study‑specific randomization is followed when dispensing and transferring study medication. Represent the pharmaceutical services department in cross‑functional meetings and communicate effectively with stakeholders. Collaborate with external partners, sponsors, and regulatory agencies to enhance the center’s reputation and capabilities. Provide regular budget updates, forecast future needs, and identify areas for optimization. Oversee relationships with pharmaceutical vendors, negotiate contracts, and ensure compliance with service‑level agreements. Execute clinical research trials in strict compliance with study protocol, GCP, ICH guidelines, SOPs, QA/QC procedures, OSHA guidelines, FDA guidelines, and applicable state and local regulations. Recruit, lead, and supervise the Pharmaceutical Services staff. Qualifications Clinical research experience preferred. Knowledge of FDA/GCP/ICH guidelines preferred. Certification / Licensure: State Registered Pharmacist. EEO Statement QPS is an equal opportunity employer. In accordance with anti‑discrimination law, it is the purpose of this policy to effectuate these principles and mandates. QPS prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. QPS conforms to the spirit as well as to the letter of all applicable laws and regulations. #J-18808-Ljbffr