Associate Director, Quantitative Clinical Pharmacology
The Importance of the Role
The Associate Director, Quantitative Clinical Pharmacology is responsible for providing translational, clinical pharmacology, and pharmacometrics deliverables for development assets from pre-IND to Phase III. This incumbent will apply quantitative modeling methodologies inclusive of population PK, PKPD, disease progression modeling using multivariate statistical and empirical approaches to integrate, analyze and interpret diverse data sources (e.g., pharmacokinetics, pharmacodynamics including biomarker & imaging, electronic health records).
This incumbent will drive and support pharmacology and pharmacometrics activities involved for dose selection and characterizing the interactions between drugs, patients, and biological systems to identify key predictors.
This is a highly visible and team-facing role.
The Opportunity to Make a Difference
- Drives the development and execution of quantitative pharmacology strategies across all stages of development through product registration
- Led clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, study reports
- Responsible for advanced quantitative pharmacology and pharmacometrics analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to yield high value PK/PD support for critical clinical decisions and dose selection
- Serves as functional lead for global regulatory strategies and regulatory documents
- Maintains leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publishes manuscripts, presents at scientific conferences and scientific forums.
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.
More About You
- PhD in Pharmaceutical Sciences, mathematics/engineering or related field with minimum of 5 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
- Experience in developing advanced pharmacometrics, PK/PD, PBPK models to aid in research and development decision making.
- Skilled in using pharmacometrics analysis software (e.g., NONMEM, R, Phoenix).
- Excellent communication, multitasking, and collaboration skills
- Strong analytical skills and strategic thinking
What Sarepta Offers
- At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives.
- We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity.
- We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
Pay and Schedule
The targeted salary range for this position is $160,800 - $201,000 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.