Pharmacology Researcher with PKPD Expertise
2 weeks ago
We are seeking a highly skilled Senior Scientist to join our Clinical Pharmacology team. This position will support the development of RNAi therapeutics and involve working with clinical stage project teams to provide PKPD support and guidance.
About the Role- Represent Clinical Pharmacology and provide PKPD support and guidance to clinical stage project teams.
- Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data.
- Conduct PK/PD analyses to guide development decisions on project teams.
- Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.
- Prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data.
- Preparation of abstracts and manuscripts for publication.
- Closely partner with Research, Bioanalytical, Clinical functions, Regulatory, Project Management, and other R&D functions.
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with some experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience.
- Working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology.
- Proficient in using Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling and data visualizations software.
- Strong communication skills (verbal and written) and presentation skills are required. Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential.
This salary range is based on industry standards and takes into account factors such as location, experience, and qualifications. We offer a competitive benefits package and opportunities for professional growth and development.
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