Sr/Director/Associate/Principal Clinical Pharmacologist/Pharmacometrician
- Employer
- Umbilical Life
- Location
- Wilmington, Delaware, Philadelphia, Baltimore, Maryland, New Jersey
- Salary
- Per Annum
- Start date
- 28 Sep 2022
- Closing date
- 25 Oct 2022
View more
- Discipline
- Data Management / Statistics, Data Analyst, R & D , Pharmacokinetics, Pharmacology
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Clinical Pharmacokinetics Experts
My client, a leading Biopharmaceutical company, is looking to grow their clinical PK group.
Looking for an accomplished clinical pharmacologist/pharmacometrician to provide strategic clinical PK support to the clinical development of small molecule and biologics drugs.
There are multiple openings in this team, seniority is based on experience,
Positions available: Director / Sr. Director, Associate Director, Principal Investigator
Responsibilities
Responsible for all aspects of clinical PK and Model informed Drug development, working across clinical project teams
Work between teams (clinicians, Biostatisticians, Translational Scientists etc.)
Design and conduct pharmacometrics analysis (author pharmacometrics data analysis plans and reports, simulation-based trial design and dose selection, population PK/PD analysis, PBPK modeling)
Review and write regulatory and registration documentation in relation to Drug Development including (clinical trial protocols and reports, investigator brochures and regulatory submission packages)
You are providing clinical pharmacology support and leadership (Written and Oral)
Present work at internal and external scientific meetings and publish manuscripts in peer-reviewed journals.
Your Profile
PHD (or Equivalent) with Industry experience (years below) in Clinical Pharmacology and Pharmacometrics
8+ years = Director / Sr. Director
5+ years = Associate Director/Director
3+ years = Principal / Associate Director
Deep understanding of Pharmacokinetics and Pharmacodynamics concepts and modeling
Broad understanding of ADME/Biopharmaceutical Properties of Small Molecules
Software: Phoenix, R, NONMEM, Monolix, MatLab, Simcyp, GastroPlus, (or other pharmacokinetic, modeling and data visualizations software)
Experience in clinical development programs and understanding of model-informed drug development strategies in relation to clinical pharmacology
Experience of regulatory submissions, such as CTAs and/or NDA/sNDA/MAA,
(Management experience is a plus)
Company
Umbilical will be a world leading provider of workforce solutions in Science, Technology and Engineering.
Blending innovation and a commitment to entrepreneurship, we will ensure our customers and colleagues achieve the highest levels of satisfaction.
With nearly 75 years of workforce industry experience between us we know a lot, but not everything.
We have created a Mission, Vision and a set of clear Values, providing‘guiding light’ as we all start building this Culture, or as we call it the CODE.
- Website
- http://umbilical.co/
- Telephone
- 011 6 461 0070
- Location
-
Premier House
9 Rutland Street
Leicester
LE1 1RE
United Kingdom
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