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new Sr. Director opportunity in clinical pharmacology in MA

From: Brenda Roseberry <broseberry>
Date: Wed, 15 Apr 2020 17:22:42 +0000

Sr. Director role in clinical pharmacology available in MA. This is a fanta=
stic "first in" opportunity. please contact me for more info. Description b=
elow. broseberry

* Lead the Clinical Pharmacology strategy to create sound, inn=
ovative and efficient programs that meet regulatory requirements, corporate=
 and R&D program goals, and facilitate development from Phase 1 to commerci=
* Provide clinical pharmacology expertise in design and analysi=
s of pharmacokinetic (PK) and pharmacodynamic (PD) aspects of clinical stud=
ies, including determining study design details, development of PK/PD model=
s, special populations, dosing, evaluating clinical safety, efficacy, and p=
atient selection strategies and predictive biomarkers
* preparation of the clinical pharmacology portions of regulato=
ry documents such as the pre-IND, IND, IB, briefing documents, clinical stu=
dy reports, CTA and filing documents, while working in collaboration with c=
ross functional team
* Work with the discovery preclinical DMPK colleagues to optimi=
ze preclinical models and inform first in patient clinical dosing strategie=
* Perform with adherence to agreed timelines and budgets to ens=
ure execution of deliverables
* Represent Clinical Pharmacology and provide subject matter ex=
pertise on cross-functional project teams, clinical study teams and transla=
tional medicine teams
* Identify/manage consultants and vendors to support Clinical P=
harmacology studies
* Excellent written and oral presentation skills
* Strong critical thinking and the ability to work effectively =
with cross-functional teams in a matrix environment
* Can work independently with minimal supervision

Position Requirements
Job Requirements:
* MD, PharmD, or PhD with at least 10 years of Clinical Pharmac=
ology experience (Level commensurate with experience-can be adjusted)
* Experience in a pharmaceutical or biotechnology industry role=
 is preferred
* Strong understanding of Clinical Pharmacology principles, the=
 drug development process and regulatory requirements to support Clinical P=
harmacology strategies
* Proven excellence in applying technical knowledge to strategi=
c planning

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

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Received on Wed Apr 15 2020 - 13:22:42 EDT

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