Filters:
Job Function: Pharmacology
Show
|
Clear
1
1 Result
Free CV Review
75% of applications never get seen. Beat the bots and get through the filters with a free CV evaluation.
AD
Sarepta Therapeutics
Cambridge, Massachusetts, United States (remote)
22 days ago
Sarepta Therapeutics
Cambridge, Massachusetts, United States
(remote)
22 days ago
Job Type
Full-Time
Min Education
Ph.D.
Job Function
Clinical

Description

The Senior Manager will prepare and develop translational and clinical pharmacology plans including dose selections and predictions using mathematical and statistical models to study complex interactions between drugs, patients, and biological systems to understand disease progression and the impact of patient stratification on disease progression and pharmacology. This role contributes to evaluating various clinical pharmacology and modeling strategies and building clinical pharmacology and pharmacometrics infrastructure.

Primary Responsibilities Include:

  • Perform advanced quantitative pharmacology and pharmacometrics analyses and activities within assigned programs to yield high value PK/PD support for critical decisions and dose selection; interprets and presents results and recommends appropriate actions.
  • Manage and develop translational and clinical pharmacology efforts such as study designs, protocol preparation, data analysis and reporting.
  • Supports the development and execution of the quantitative pharmacology strategy of nonclinical and clinical development teams.
  • Provide insightful regulatory strategy for clinical pharmacology and pharmacometrics support of drug filings and is responsible for the respective sections of regulatory documents.
  • Develop and maintain strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent.
  • Develop and maintain scientific awareness and presence in the clinical pharmacology and pharmacometric discipline, publishes manuscripts and posters, presents at scientific conferences and other scientific forums.
  • Perform other related duties as assigned.

Desired Education and Skills: 

  • PhD degree in Pharmacokinetics-Pharmacodynamics, Pharmacometrics, biomedical engineering, statistics, applied mathematics, or a related field with a minimum of 3 years of experience working as a clinical pharmacologist or pharmacometrician within pharmaceutical industry. A MSc degree with relevant experience is also considered with at least 5 years of relevant experience.
  • Experience in developing advanced quantitative system in Pharmacometrics, PK/PD, PBPK models to aid in research and development decision making.
  • Experience in ASO, GTx or rare diseases is a plus.
  • Knowledge of Health Authority perspective on use of modeling and simulation.
  • Excellent interpersonal, collaboration, English communication skills (both written and verbal).
  • Strong analytical skills and strategic thinking. 
  • Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary.
  • Self-motivated with strong work ethic and the ability to work independently and efficiently.
  • Experience working with stakeholders/partners at all levels, globally, across the organization.


Job ID: 73255834

Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at www.sarepta.com.

View Full Profile

Jobs You May Like
Filters
Workplace Type
Job Function
Industry
State