Job Summary In compliance with goals, policies, and objectives established by site and global leadership, this position is responsible for the management of on-going projects at QPS MRA. Leads, oversees, and ensures the accuracy and timely development, implementation and completion of the projects to client and industry expectations and standards. Responsible for managing and ensuring accurate and timely information path to other team members, third party vendors and clients. Leads the project team during all phases of the project, and serves as primary contact for the team to ensure open lines of communication throughout the entire project lifecycle.  

Essential Functions 

-Advises Clinical executive management at QPS MRA and globally on strategic developments in the Clinical Pharmacology field

-Up to date knowledge on relevant international and local law and guidelines for conduct of clinical pharmacology studies at any of QPS’ facilities.

-Advises on study feasibility based on pharmacology, preclinical safety, pharmacokinetics and pharmaceutical aspects of the compound and QPS’ expertise and capacities. 

-Advises project teams on the execution of the clinical studies in order to guarantee flawless conduct of study. After completion of studies, supports in evaluating study and performance as lessons learned activities.

-If necessary advices on processes, staffing and systems to improve study quality and or customer satisfaction.

-Supervises clinical studies from a clinical pharmacology and scientific perspective

-Develops and maintains clinical pharmacology knowledge to serve internal (QPS MR & globally) and External (Client) needs.

-Develops and maintain a global network of experts to support early phase clinical studies.

-Initiates and coordinates strategic initiatives to maintain and improve Early Phase Clinical strength at QPS

-Initiates, coordinates or writes scientific publications

-Reviews and discusses the feasibility of client requests for early phase clinical studies based on scientific design and Client needs

-Provides input on designs of early phase clinical studies for any of QPS facilities taking into account both scientific and operational aspects

-On request develops study designs for clinical pharmacology studies. The Director Clinical Pharmacology will work in close collaboration with subject matter experts (internal or external) and local QPS sites

-Supports of Business Development in the acquisition process and participation in sponsor visits.

-Attendance of scientific meetings to represent QPS.

-Maintains knowledge of relevant international regulatory guidelines (GCP, ICH, FDA, JFDA, EMA, DCGI) and consults with clients, internal staff and other stakeholders  

-Consults with Sponsor on clinical studies and clinical development programs

-Will on request be involved in evaluating the feedback of the sponsor and QPS performance and advises in taking the desired actions to be in line with scientific and Sponsor needs.

-Maintains contact with other QPS site managers/staff on aspects of early stage clinical development projects/studies relevant for that site

-Be involved in the CSR writing and reviewing process e.g. by writing discussion sections of the CSR if applicable, review of the CSR and discussions with the sponsor on review comments

In addition to these tasks, other not described tasks can be performed by the Director Clinical Pharmacology upon discussion with Division Director Clinical Pharmacology.

Knowledge/Skills/Abilities 

-Extensive working knowledge of GCP, ICH and FDA Regulations

-Extensive knowledge of clinical drug development and approval process.

-Excellent written and oral presentation skills

-Ability to work well in a team environment with an ability to lead and facilitate teams effectively.

-Ability to evaluate and revise SOP’s effectively.

-Knowledge and ability to understand complex financial aspects of organization and industry.

Education/Experience The level of education for this function should be at least PhD degree in medical, pharmaceutical or biological sciences.

Minimal 10 years’ experience as Clinical Pharmacologist, Scientist, Research Physician or a comparable function in clinical research.

Experience in clinical pharmacology, project management and knowledge of CROs and pharmaceutical Industry with a focus on early stage clinical development.

Excellent knowledge of the English language.

Employees with different background or experience, to be assessed by the Division Director Clinical Pharmacology can be considered suitable for the function of Director Clinical Pharmacology.

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer.  In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.