Reports to: Head of Clinical Pharmacology and Pharmacometrics
The Pharmacokinetic Scientist is responsible for providing scientific and operational support to studies aimed at determining the pharmacokinetics (PK) and pharmacodynamics (PD) of clinical drug candidates within PMV Pharma’s oncology portfolio. The PK Scientist will work with the Head of Pharmacology and cross-functional teams to develop and execute Clinical Pharmacology Plans and clinical study protocols in accordance with company Standard Operating Procedures (SOPs) and industry regulatory guidelines (GxP).
This is a hybrid home/office-based position with regular visits to New Jersey HQ (several days per month; up to 1 week per month).
- Contributes to the development of the Clinical Pharmacology Plans for pipeline products together with the Head of Clinical Pharmacology
- Contributes to design and execution of Clinical Pharmacology studies in collaboration with cross-functional teams.
- Contributes to modeling and simulation plans
- Applies Pharmacokinetics/Pharmacodynamics principles and model-based analyses to perform real time PK data analysis and reporting
- Contributes to the provisioning of clinical biomarker datasets and supports the clinical biomarker lead on the analysis and interpretation of biomarker data
- Contribute to the clinical development strategy of pipeline products
- Contributes to the interpretation of PK, biomarker, pharmacogenomic, PK/PD, population PK, and exposure-response results
- Presents study results to the cross-functional study team and/or Development Team as appropriate.
- Prepares PK/PD, population PK, and E-R study reports and other regulatory documents
- Collaborates with the cross-functional Development team on preparation of key regulatory documents, interactions with health authorities and regulatory submissions
- Contributes to the preparation of scientific presentations and publications
- Contributes to departmental continuous improvement initiatives
- Assists with training and developing employees
- MS, PhD or PharmD or equivalent in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields
- Proficient in PK, PK/PD, and Model Informed Drug Development (MIDD) principles and analyses
- 2+ years of industry or academic experience working in R&D with demonstrated knowledge of Clinical Pharmacology and Pharmacometrics and the drug development process
- Proficiency in software used for pharmacokinetic and modeling analysis (e.g., Phoenix NLME, NONMEM, R, WinNonlin. SAS, Splus, etc.)
- Able to perform dataset construction
- Knowledge of current practices and issues in Clinical Pharmacology and Pharmacometrics
- Strong written and oral communication skills necessary to report on and deliver scientific presentations
- Demonstrated ability to work in a dynamic team-oriented environment
- Quantitative data analysis, POP PK/PD, and data visualization skills are highly desired
- PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.
How to Apply
PLEASE, NO PHONE CALLS or AGENCIES
PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.