[NMusers] Biopharmaceutical PK/PD Position - Assistance

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:richardb_at_wilmingtongroup.com> richardb_at_wilmingtongroup.com

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.
  


Received on Fri Jun 29 2007 - 14:53:30 EDT