Introduction:
qPharmetra provides clinical pharmacology and pharmacometrics expertise to clients in pursuit of new medicines to treat unmet patient need. We are located in the US and Europe and provide career opportunities for scientists that share our commitment to help our clients make better decisions for developing medicines to improve the lives of patients.
The clinical pharmacology team is responsible for providing clients and the team at qPharmetra with guidance on clinical strategy and the design, execution, analysis, and reporting of clinical pharmacology studies. We also work with our colleagues for the integration of pharmacometric methodologies during all phases of drug development. At every opportunity, whether working with clients, business partners, or regulatory agencies, we strive to communicate clearly and with a sound scientific rationale.
This Quantitative Clinical Pharmacology Consultant position will preferably be held by a scientist interested in both hands-on PK and/or PKPD analyses and the entire clinical pharmacology development program.
Responsibilities:
- Provide consulting to clients
- Together with senior colleagues, develop and implement strategic plans to answer important clinical pharmacology questions
- Contribute to design of clinical studies and interpretation of study results
- Evaluation of non-clinical data
- Contribute to regulatory documentation, interactions and meetings.
- Perform and Report PK and/or PKPD analyses to regulatory standards
- Support dose/dosing regimen decisions throughout drug development
- Represent qPharmetra at conferences and in meetings with potential new clients
Requirements:
You hold a PhD within Clinical Pharmacology or Pharmacokinetics or PharmD (or equivalent) and you have ≥2 years of industry or regulatory experience. You are positive, self-motivated, are comfortable working independently and collaboratively, and you possess excellent communication skills; you deliver high quality work within defined timelines.
You have hands-on experience performing PK analyses and reporting, you have a keen interest in clinical pharmacology. You have a strong intellectual curiosity and desire to learn more about various therapeutic areas, quantitative clinical pharmacology, model informed drug development, and regulatory guidelines and requirements.
Desirable Characteristics:
- Understanding of regulatory requirements and guidance for clinical pharmacology studies
- Hands on experience performing PK and or PKPD analyses (NCA and/or Population PK and/or PKPD)
- Experience in interpreting results from nonclinical studies (e.g. protein binding, absorption, metabolism, transporters, inhibition and induction studies, target binding or other pharmacodynamic in vitro studies)
- Experience in planning and interpreting results from clinical pharmacology studies e.g. ADME, BE, DDI, organ impairment and pediatric studies.
- Use of and/or interpretation of results from typically used software tools (NONMEM, Berkeley Madonna, PK-Sim/MoBi, SimCyp, etc.)
- Experience with R and LateX
If you want to join us please send your resumé to .
qPharmetra does not accept unrequested help from recruiters for this job opening. Resumes (in whatever shape or form) that are sent by recruiters to qPharmetra or any employee of qPharmetra without a written assignment of a recruiter, will automatically be considered property of qPharmetra and not constitute a basis for any claim or any form of compensation to the recruiter payable by qPharmetra.
