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new clinical pharmacology role in MA

From: Brenda Roseberry <broseberry>
Date: Wed, 29 Jan 2020 16:29:55 +0000

Sr. Manager/Associate Director level role in MA. Please send resume or ques=
tions to broseberry

The Senior Manager/Associate Director of Clinical Pharmacology will be resp=
onsible for all aspects of the clinical pharmacology strategy including ear=
ly (Phase 1) and late stage development (Phase 2/3 and NDA filings). This i=
ndividual will provide strategic leadership and execution of clinical devel=
opment plans that include characterization and prediction of the pharmacoki=
netics, pharmacodynamics, and drug metabolism of the drug candidate in sele=
cted preclinical and all clinical areas. She/he will also provide rationale=
 for dose regimen selection, safety margin assessment and identification of=
 circumstances where dose adjustment or patient selection/stratification sh=
ould be considered.
Key Responsibilities

  * Plan, prepare and review drug development plans and regulatory filing=
  * Determine scope, design, and planning and analysis of phase 1-4 pharm=
acokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations =
required from a drug development and regulatory perspective to take a proje=
ct from concept to commercialization. Responsibilities include describing r=
esults of these studies in regulatory documents (IND's NDA's, IB's, etc.)
  * Responsible for protocol design, study planning, review, data analysi=
s / interpretation, and reporting of individual studies implemented to supp=
ort clinical pharmacology components of project plans
  * respond to regulatory inquires related to DMPK, PK/PD, and clinical p=
  * Ensure appropriate PK/PD analysis including population PK, PK/PD mode=
ling and simulation, meta-analysis, mechanistic modelling, disease state mo=
delling as required to aid in data interpretation, trial design and/or prog=
ram decision-making
  * Participate in writing publications and making scientific presentatio=
ns consistent with development strategies and publication plan
  * Collaborate with preclinical development colleagues on the scientific=
/technical aspects of assigned studies from conception through final report=
, including protocol development, budget, timelines, sample handling/proces=
sing, bioanalysis (through CRO), and PK data analysis/interpretation
  * Maintain knowledge of relevant scientific and regulatory practices, g=
uidance and trends, and ensure that clinical pharmacology aspects of develo=
pment programs are contemporary

  * PhD, PharmD or equivalent training in pharmaceutical sciences, pharma=
cokinetics, mathematics, or a related scientific discipline is required
  * For Sr. Manager, minimum of 3 years of experience in clinical pharmac=
ology, clinical PK/PD or pharmacometrics in the biopharmaceutical industry =
is required for the Senior Manager level. A minimum of 6 - 8 years of relev=
ant experience is required for the Associate Director level
  * Extensive understanding and hands-on experience with Modeling and Sim=
ulation (M&S) techniques in drug development (ie. PK/PD, PB/PK, systems mod=
elling, mechanistic modeling, population PK)
  * Experience preparing regulatory documents, such as IND's and NDA's, a=
s well as prior direct involvement with major regulatory filings
  * Expertise in providing relevant vendor and consultant oversight
  * Thorough knowledge and understanding of Good Clinical Practices (GCP)=
, the clinical research drug development process, clinical investigational =
trials, and corresponding roles and activities
  * Excellent written and verbal communication skills. Ability to create =
high quality written reports and summary documents for use in regulatory su=
  * Ability to work independently and in multi-disciplinary teams

Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
    720-328-9526 - Office
    315-415-4353 - Mobile
    720-475-1176 - Fax

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Received on Wed Jan 29 2020 - 11:29:55 EST

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