Associate Director, Pharmacometrics
Roivant Sciences is seeking an associate director (or other based on
qualifications) of pharmacometrics to join our growing team!
Roivant is dedicated to transformative innovation in healthcare. Our mission is
to systematically reduce the time and cost of the drug development process. We
partner with innovative biopharmaceutical companies and academic institutions
to ensure that important medicines are rapidly delivered to patients. Our goal
is to serve our partners, contribute positively to the healthcare system, and
improve the lives of patients around the world.
Roivant is the parent of a growing family of companies focused on diverse
therapeutic areas including neurology, dermatology, urology, endocrinology,
women's health, and rare diseases.
JOB SUMMARY
This individual will be responsible for pharmacometrics support of drug
development programs across therapeutic areas and all phases of clinical
development. 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 expertise in
quantitative pharmacology and modelling and simulation. They may perform
pharmacometric analyses under the supervision of senior clinical
pharmacologists/pharmacometricians and provide scientific oversight of
pharmacometric analyses performed at CROs. Responsibilities will include
writing and review 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 methods.
RESPONSIBILITIES
* Serve in the role of pharmacometrician to provide data analyses,
modeling, and simulation to support asset development in support of a project
team 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
writing 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 CROs.
* Occasional travel (< 5% of time)
QUALIFICATIONS
* 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 team
or as a consultant to a drug development team
* Experience with pharmacometrics support for regulatory submissions and
interactions
* Experience with Population PK/PD modeling is required
* Experience with PBPK modeling is preferred
REQUIRED CHARACTERISTICS
* 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 the
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
brendan.johnson_at_roivant.com<mailto:[email protected]>
http://www.roivant.com/
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