Good afternoon, this is Richard Babb with The Wilmington Group
(www.wilmingtongroup.com), I am the Vice-president over our retained executive
search firm's pharmaceutical operations and we work across the
biotech/pharmaceutical/CRO arena from Director to CEO/Chairman opportunities.
We are working on an exciting PK/PD Director search with a biopharmaceutical
client in the mid-Atlantic area; they are looking for a Director to Head
pre-clinical PK/PD and collaborate with the Translational Sciences Division.
This position requires technical expertise (dose/concentration response
background) with the strategic know-how to influence several diverse
pre-clinical therapeutic groups. Please review the following job specifications
at your convenience and contact me with any recommendations/questions. Thanks
again for your time and take care.
Richard Babb
Vice President - The Wilmington Group
910-256-1056
<mailto:[EMAIL PROTECTED]> [EMAIL PROTECTED]
Director of Pharmacokinetics/Pharmacodynamics
Position Summary: Provide pharmacokinetic and pharmacodynamic expertise to
pre-clinical research and Translational Sciences teams, actively collaborate
with Translational Sciences and pre-clinical research team members to design
appropriate pre-clinical efficacy/safety/biomarker/pharmacology studies and
utilize PK/PD modeling skills to evaluate results. Apply PK/PD modeling and
simulation for selection of dose and dosing schedule for pre-clinical and
toxicological studies. Provide drug metabolism and pharmacokinetics (DMPK)
expertise.
Major Duties and Responsibilities (including supervising others):
* Plan, design, analyze, interpret and report pharmacokinetic and
pharmacodynamic data from pre-clinical studies
* Provide expert advice on issues relating to PK, PD, metabolism and
dose/regimen selection to pre-clinical research and translational sciences
teams
* Provide expert advice dose/regimen selection for toxicological
evaluation of compounds
* Design appropriate pre-clinical exposure-response studies and evaluate
activity/safety of drug candidates
* Perform PK and PK/PD analysis and interpretation of pre-clinical
studies
* Perform PK, PD and PK/PD simulations of pre-clinical studies
* Identify and investigate relationship between PK and efficacy/safety
biomarkers in pre-clinical studies and advice on their relevance to clinic
* Prepare PK, PD, PK/PD and drug metabolism components of investigator's
brochure, study protocols, study reports, project summaries and development
plans
* Interpret and present project related pre-clinical study results and
recommendations to management and relevant project teams
* Interact cross-functionally with other departments including Research,
Translational Sciences, Clinical Testing, Biostatistics, Clinical Development
and Regulatory Affairs groups.
* Provide PK support for formulation development
* Prepare and/or review PK, PK/PD components of internal documents,
briefing books and regulatory submission documents (e.g. IND and other
regulatory documents)
* Prepare appropriate responses to Health Authority Inquiries on
pre-clinical PK and PK/PD related issues
* Provide pre-clinical drug metabolism and PK and PK/PD expertise in
regulatory and other advisory meetings
* Prepare and review scientific publications and abstracts.
* Pharmacokinetics & Pharmacodynamics department representative on
pre-clinical project teams
Requirements/Qualifications:
Education: Candidates with a Ph.D (or equivalent)
degree in pharmacokinetics, pharmacology, biopharmaceutics or related field
Experience: At least 6 years of pharmaceutical
industry experience. Should have hands-on experience modeling with WinNonlin
and be familiar with pre-clinical pharmacology and translational research
activities.
Special Skills/Abilities:
* Candidate should possess good understanding of pharmacokinetic and
pharmacodynamic principles
* Experience in planning, designing, interpreting and reporting of
pre-clinical pharmacokinetic/ pharmacodynamic studies and translational
research studies is essential
* Strong written and oral communication skills and interpersonal skills are
essential
* Candidate should be proficiency with WinNonlin or other commonly used PK
and PK/PD software is essential
* Candidate should possess good PK/PD modeling skills
* Candidate should possess good translational research skills
* Experience in population PK/PD modeling and simulation using NONMEM is a
plus
Job Complexity: Ability to evaluate and interpret
standard and complex pharmacokinetic and pharmacodynamic scenarios in order to
evaluate drug candidates and explore their activity/safety pre-clinically to
aid rational and informed decision making in drug development.
Supervision: Ability to work independently with
minimal supervision. Should be able to multi-task and prioritize assignments.
Able to work well with interdisciplinary teams and represent pharmacokinetics
and pharmacodynamics effectively on pre-clinical project teams.