What are the responsibilities and job description for the Director Clinical Pharmacy position at QPS, LLC?
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. We welcome individuals who want to be part of our growing organization. QPS is an innovative, dynamic organization that strives to employ talented, caring and committed employees who will work collaboratively towards achieving our mission of improving human health and the quality of life. QPS offers challenging and rewarding work in its four core business areas and support functions. Underpinning the operation is 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.
Description:
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.
The Director, Clinical Pharmacy plays a pivotal role in our clinical research center, overseeing and managing all pharmaceutical aspects of our operations. 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 our organization.
The Director, Clinical Pharmacy will be responsible to report any noncompliance issues to Vice President, 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 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.
QUALIFICATIONS:
- Ten years or more of related experience, preferably in a clinical environment, clinical research experience preferred.
- Previous experience in any of the following: protocol development, clinical conduct of a study, report writing, project management, or pharmacokinetics.
- Clinical research experience preferred.
- Strong knowledge of FDA/GCP/ICH guidelines.
- Certification / Licensure: State Registered Pharmacist
EEO Minorities/Females/Protected Veterans/Disabled
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.