Associate Director QCP
Associate Director QCP
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$ 156000 - 195000
1 Vacancy
Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
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 worklife 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: Importance of the Role
The Associate Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical pharmacology and pharmacometrics deliverables from early through latestage clinical development (Ph3 and product registration) with an emphasis on clinical dose selection/refinement and predictive PK/PD modeling inclusive of population and statisticallybased methodologies as well as mechanistic and translationalfocused approaches. This is a highly visible and teamfacing role.The Opportunity to Make a Difference
- Drives the development and of 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 data review/analysis study reports
- Responsible for modelbased data analyses including population PK PK/PD modeling and simulation metaanalysis disease modeling to inform clinical development
- Serves as functional lead for global regulatory strategies and HA engagements
- Maintains leadingedge 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 4 years of experience working in clinical pharmacology or pharmacometrics
- Strong understanding of clinical pharmacology principles strong handson experience with PK/PD modeling analysis and experience in regulatory interactions
- Excellent communication multitasking and collaboration skills
What Now
Were always looking for solutionoriented critical thinkers.
So if youre 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.
Required Experience:
Director
Employment Type
Full-Time
