NONMEM Users Network Archive

Hosted by Cognigen

Manager/AD role clinical pharmacology in MA

From: Brenda Roseberry <broseberry>
Date: Thu, 13 Feb 2020 18:50:32 +0000

Manager/ Associate Director role available in Massachusetts, please contact=
 me for more info 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. This individual will also provide =
 dose regimen and patient selection rationale.
 Responsibilities

  * Plan, prepare and review drug development plans and regulatory filing=
s
  * 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
  * Represent Dicerna with regulatory agencies and respond to regulatory =
inquires related to DMPK, PK/PD, and clinical pharmacology
  * 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
Qualifications

  * PhD, PharmD or equivalent training in pharmaceutical sciences, pharma=
cokinetics, mathematics, or a related scientific discipline is required
  * Minimum of 3 years of experience in clinical pharmacology, clinical P=
K/PD or modeling/simulation in the biopharmaceutical industry is required f=
or the Senior Manager level. A minimum of 6 - 8 years of relevant experienc=
e 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
  * Partner with CRO's
  * knowledge and understanding of Good Clinical Practices (GCP), the cli=
nical research drug development process, clinical investigational trials, a=
nd corresponding roles and activities



[cid:image001.png
Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
    720-328-9526 - Office
    315-415-4353 - Mobile
    720-475-1176 - Fax
   [cid:image002.png
ew?id=19937880&authType=name&authToken=b5d_>



image001.png
(image/png attachment: image001.png)

image002.png
(image/png attachment: image002.png)

Received on Thu Feb 13 2020 - 13:50:32 EST

The NONMEM Users Network is maintained by ICON plc. Requests to subscribe to the network should be sent to: nmusers-request@iconplc.com.

Once subscribed, you may contribute to the discussion by emailing: nmusers@globomaxnm.com.