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 Senior Quantitative Clinical Pharmacology position will preferably be held by a senior scientist interested in the clinical pharmacology strategy planning, designing and interpreting data from clinical pharmacology studies as well as strategic planning, executing and reporting PK and PKPD analyses.
- Provide expert consulting to clients
- Develop and implement strategic plans to answer important clinical pharmacology questions
- Support dose/dosing regimen decisions throughout drug development
- Design clinical studies and interpretation of PK and PKPD results from the studies
- Evaluate and plan non-clinical PK and PD studies
- Contribute to regulatory documentation, interactions and meetings.
- Develop strategic Modeling and Simulation plans, execute and review PK and/or PKPD analyses, write reports to regulatory standards
- Represent qPharmetra to potential new customers and contribute to strategic plans to grow the quantitative clinical pharmacology business
- Write statements of work
- Collaborate within qPharmetra by, for example, training and supervising less experienced consultants or development of internal capabilities.
- Produce high quality publications and presentations
You hold a PhD within Clinical Pharmacology or Pharmacokinetics or a PharmD (or equivalent) and you have minimum 5 years 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 designed and interpreted the results of clinical pharmacology studies (e.g. ADME, BE, DDI and studies in special populations) and pharmacodynamic studies (e.g. target, biomarkers and tQTc) in new drug development. You are familiar with population PK and PKPD modeling, model-informed drug development and design of pediatric studies. You have experience interpreting results from nonclinical studies (e.g. protein binding, absorption, metabolism, transporters, inhibition and induction studies). We expect you to have a good understanding of regulatory requirements of the overall clinical pharmacology program. Preferably, you have experience working with small and large molecules in several therapeutic areas. You have a strong intellectual curiosity and desire to learn more about different therapeutic areas as well as a desire to expand your quantitative skills.
Alternatively, you have minimum 5 years’ experience in hands on population PKPD modelling and a genuine interest in developing quantitative clinical pharmacology strategy and learning regulatory requirements and guidance.
- Consulting experience
- Experience of representing Quantitative Clinical Pharmacology in cross-functional project teams
- Hands on experience performing PK and/or PKPD analyses (NCA and/or Population PK and or PKPD)
- 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
- Publication track record and visibility in the clinical pharmacology community or pharmacometrics community
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.