Associate Director PKDM
10 hours ago
*Urgent*
Associate Director PKDM – Cambridge, MA or New Jersey
50% home working on offer
Pharmacology, Pharmacokinetics, PKPD, Clinical, Modelling & Simulation, Drug Development
KEMIO are working with a global pharmaceutical company buiilding on their capabilities in Pharmacokinetics, Dynamics, and Metabolism. This Associate Director role will be based either in Cambridge or New Jersey (hybrid working on offer) and it will be perfect for a candidate with a PhD and at least 5 years of experience in clinical PK/PD, pharmacometrics, and/or clinical pharmacology. We will look for up to 10-15 years working experience if you hold an MS or BS.
You will join an established PK department who contribute to the safe and effective therapeutic treatment by applying appropriate pharmacokinetic and pharmacodynamic (PKPD) principles to drug development. We are seeking an experienced individual to serve as a PK/PD expert to accelerate projects where possible and be involved in the following:
Responsibilities:
- Serving as a PKDM representative on project team/s
- Participating in clinical phase development projects in different therapeutic areas
- Works in close collaboration to progress drug candidates from IND through early phase/late phase to successful approval
- Designing, planning and overseeing relevant studies, as well as PK/PD analysis, interpretation, and reporting of results for molecules/compounds in clinical stage
- Applying quantitative skills, via modeling and simulation, to provide dose selection and complex issues at various stages of drug development.
- Responsible for clinical pharmacology contributions to regulatory documents and inquiries.
- Interfacing with discovery research during the pre-IND stages of drug development to ensure sufficient PK/PD knowledge exists for translation to the clinic.
Experience required:
- Earned Ph.D. degree in clinical pharmacology, pharmacokinetics, pharmacometrics, mathematics, engineering, computational biology or a related field required, with or without post-doctoral experience plus 5 years of relevant experience
- OR MS/MA degree in fields listed above plus at least 12 years of relevant experience
- OR BS/BA degree in fields listed above plus at least 14 years of relevant experience
- 5 years+ of experience in clinical PK/PD, pharmacometrics, and/or clinical pharmacology
- Proficient in PK modeling software/platforms.
- Effective communication and interpersonal skills.
- Strong presentation skills
Please send along your resume to Jade @ KEMIO Consulting for a confidential discussion about the role and company. We look forward to hearing from you
Keywords: Clinical Pharmacology, Pharmacokinetics, Drug Metabolism, Clinical, PK/PD, Pharmaceuticals, Research and Development, Boston, Cambridge, New Jersey
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