Sarepta Therapeutics

Director, Quantitative Clinical Pharmacology: PK/PD Modeling & Strategy

Sarepta Therapeutics • $185K — $232K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • PhD in Pharmaceutical Sciences, mathematics/engineering or related field.
  • 7+ years of experience in clinical pharmacology or pharmacometrics.
  • Strong understanding of clinical pharmacology principles.
  • Hands-on experience with PK/PD modeling analysis.
  • Experience in regulatory interactions.

Responsibilities

  • Drive development and execution of quantitative pharmacology strategies.
  • Lead clinical pharmacology expertise in development strategies and protocol preparation.
  • Oversee model-based data analyses including population PK and PK/PD modeling.
  • Serve as functional lead for global regulatory strategies.
  • Maintain cutting-edge knowledge in clinical pharmacology and publish manuscripts.

Benefits

  • Hybrid work environment with on-site expectations at facilities.
  • Opportunities to attend company-sponsored in-person events.
  • Competitive compensation and benefits package.
Full Job Description
The Importance of the Role
The Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Ph3 and product registration), with an emphasis on clinical dose selection/refinement and predictive PK/PD modeling inclusive of population and statistically-based methodologies, as well as mechanistic and translational-focused approaches. This is a highly visible and team-facing role.

The Opportunity to Make a Difference
  • Drives the development and execution of the quantitative pharmacology strategies across all stages of drug development through product registration
  • Leads clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, study reports
  • Responsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to inform clinical development
  • Serves as functional lead for global regulatory strategies and HA engagements
  • Maintains leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publishes manuscripts, presents at scientific conferences and scientific forums.


More about You
  • PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years of experience working in clinical pharmacology or pharmacometrics
  • Strong understanding of clinical pharmacology principles, strong hands-on experience with PK/PD modeling analysis, and experience in regulatory interactions
  • Excellent communication, multitasking, and collaboration skills


What Now?

We're always looking for solution-oriented, critical thinkers.

So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

#LI-Hybrid

This position is hybrid, 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 $185,600 - $232,000 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.

About Sarepta Therapeutics

Sarepta Therapeutics, Inc. is an American biotechnology company focused on the discovery and development of RNA-targeted therapeutics. The company's lead product candidate is eteplirsen, a treatment for Duchenne muscular dystrophy (DMD). The company is also developing other RNA-targeted therapeutics for the treatment of other neuromuscular and infectious diseases. Sarepta Therapeutics was founded in 1980 as AntiVirals, Inc. and changed its name to AVI BioPharma, Inc. in 2000. The company changed its name to Sarepta Therapeutics, Inc. in 2012.
Learn more about Sarepta Therapeutics
Size
840 employees
Market Cap
$11.3 billion
Industry
Net Income
-$554.1 million
Founded
1980
5 Year Trend
+164.5%
Revenue
$540 million
NASDAQ

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