Senior Director Quantitative Clinical Pharmacology Pharmacometrics
Senior Director Quantitative Clinical Pharmacology Pharmacometrics
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$ 216000 - 270000
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 function of Quantitative & Clinical Pharmacology (QCP) at Sarepta Therapeutics is seeking applicants for a Senior Director of Clinical Pharmacology and Pharmacometrics to help drive forward our patientcentric mission scientific innovation and expanding pipeline in precision genetic therapies. This is a highly visible teamfacing and leadership position that will partner closely with two other groups within QCP Translational Pharmacology QSP and Data Analytics as well as crossfunctionally across the R&D organization. The incumbent will serve as a therapeutic area lead in neuromuscular diseases and will enhance the existing capabilities and talents in a highperforming Clinical Pharmacology and Pharmacometrics team. A successful candidate must have a demonstrated trackrecord of driving success in clinical pharmacology MIDD and regulatory negotiations as an individual contributor and team leader.This leadership role will be developing and executing clinical pharmacology and pharmacometrics strategies and deliverables from early through latestage clinical development. Key areas of emphasis will include but are not limited to clinical dose selection and refinement across all phases of clinical development FIH and clinical pharmacology study designs development and handson application of MIDD using population and statistically based methodologies as well as mechanistic and translational PK/PD approaches. This role will manage a team of scientists and serve as a SME on programs.
The Opportunity to Make a Difference
Primary Responsibilities Include:
- Lead clinical pharmacology and pharmacometrics team in neuromuscular diseases (rare disease drug development experience preferred)
- Represent as therapeutic lead and SME in clinical pharmacology strategies clinical study protocol preparation study data review/analysis and study reports
- Lead the development and of pharmacometrics strategies across all stages of drug development through product registration
- Lead and execute modelbased data analyses including population PK PK/PD modeling and simulations metaanalysis disease modeling to inform clinical development
- Represent as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience is a must)
- Supervise mentor and develop a team of highperforming scientists
- Contribute to platformbased pharmacology activities across novel genetic modalities and disease indications
- Encompass leadingedge knowledge in clinical pharmacology and pharmacometrics discipline publish manuscripts advocate scientific leadership at external conferences and scientific community.
More about You
Education and Skills Requirements:
- PhD in Clinical Pharmacology Pharmacometrics Pharmaceutical Sciences or related field with 10 years of experience working in biotech or pharmaceutical industry
- Expertise in clinical pharmacology and pharmacometrics principles strong handson experience in modeling and data analytics and proven success in regulatory interactions from IND through registration
- Demonstrated success in leading and building highperforming teams with a strong commitment to people development
- Excellent communication multitasking and collaboration skills in crossfunctional and matrixed team environments
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:
Exec
Employment Type
Full-Time
