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Pharmacometrics Role

From: Brendan Johnson <Brendan.johnson>
Date: Mon, 26 Feb 2018 16:20:34 +0000

Associate Director, Pharmacometrics

Roivant Sciences is seeking an associate director (or other based on qualif=
ications) of pharmacometrics to join our growing team!
Roivant is dedicated to transformative innovation in healthcare. Our missio=
n is to systematically reduce the time and cost of the drug development pro=
cess. We partner with innovative biopharmaceutical companies and academic i=
nstitutions to ensure that important medicines are rapidly delivered to pat=
ients. Our goal is to serve our partners, contribute positively to the heal=
thcare system, and improve the lives of patients around the world.
Roivant is the parent of a growing family of companies focused on diverse t=
herapeutic areas including neurology, dermatology, urology, endocrinology, =
women's health, and rare diseases.

This individual will be responsible for pharmacometrics support of drug dev=
elopment programs across therapeutic areas and all phases of clinical devel=
opment. The pharmacometrician will inform dose selection, trial design, and=
 Go/No-Go decisions using model-based analyses. The individual will support=
 project teams and clinical pharmacology team members by providing expertis=
e in quantitative pharmacology and modelling and simulation. They may perfo=
rm pharmacometric analyses under the supervision of senior clinical pharmac=
ologists/pharmacometricians and provide scientific oversight of pharmacomet=
ric analyses performed at CROs. Responsibilities will include writing and r=
eview of regulatory documents and pharmacometric analysis plans and reports=
. They will also assist in due diligence efforts for potential acquisition=
 of new products and/or technologies by applying pharmacometric analysis me=

  * Serve in the role of pharmacometrician to provide data analyses, mode=
ling, and simulation to support asset development in support of a project t=
eam or for the clinical pharmacology lead
  * Develop model-based analyses to inform key drug development decisions
  * Provide population analyses for Phase 2 and Phase 3 studies
  * Support pharmacometric aspects of regulatory submissions including wr=
iting and review of relevant sections
  * Provide support to due diligences of potential acquisitions providing=
 pharmacometric analysis that will inform decision making
  * Provide scientific oversight of pharmacometric analyses performed at =
  * Occasional travel (< 5% of time)

  * Bachelors, MD, PharmD, or PhD degree
  * Minimum 2 years' experience in the pharmaceutical industry planning, =
conducting, reporting, and managing pharmacometric analyses
  * Experience includes a supportive role on a drug development project t=
eam or as a consultant to a drug development team
  * Experience with pharmacometrics support for regulatory submissions an=
d interactions
  * Experience with Population PK/PD modeling is required
  * Experience with PBPK modeling is preferred

  * Deeply motivated self-starter with an entrepreneurial spirit
  * Desire to work in a quickly changing, fast-paced environment
  * Unrelenting dedication to delivering results and a desire to shape th=
e strategic goals of the business
  * Ability to overcome ambiguity and challenge the status quo
  * Willing to roll up your sleeves to get the job done

Brendan M. Johnson, Ph.D.
Senior Director, Pharmacokinetics
Roivant Sciences, Inc.
324 Blackwell St, Suite 1220,
Durham, NC 27701<mailto:brendan.johnson<>

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Received on Mon Feb 26 2018 - 11:20:34 EST

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