SENIOR MANAGER, QUANTITATIVE

2 weeks ago

Cambridge MA USA, United States Sarepta Therapeutics Inc. Full time
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.

#LI-TD1

#LI-Remote

This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $132,000 - $165,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

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