Senior/ Scientific Director, Quantitative Pharmacology

Employer
Location
, Europe
Salary
Competitive
Posted
Dec 06, 2017
Closes
Dec 14, 2017
Ref
959700886
Contract Type
Full Time
Summary of Key Responsibilities:

- Represent PK 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
- Develop model-based justifications for optimal doses selected for pivotal clinical trials, while working in close partnership with pharmacometrics, clinical Development and statisticians.
- Develop an understanding of the relationship between clinical data and preclinical findings to inform individual development programs as well as broader technology platform research initiatives.
- Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.
- Design and oversee the conduct of clinical pharmacology studies (either standalone or within broader clinical trials) to generate high quality and relevant data.
- Network with external expert consultants, CRO partners and academic sites to problem solve and develop scientific solutions to clinical pharmacology issues.
- Lead and prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
- Participates in the preparation of abstracts and manuscripts for publication
- Closely partner with Research, Bioanalytical, Clinical functions, Regulatory, Project Management, and other R&D functions.

Qualifications:

- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 3-6 years' experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience
- Strong working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology.
- Proficient in using Phoenix WinNonlin, NONMEM, or other pharmacokinetic and modeling 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.