Senior Director Translational Pharmacology
Senior Director Translational Pharmacology
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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 Translational Pharmacology 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 Clinical Pharmacology & Pharmacometrics QSP & Data Analytics as well as crossfunctionally across the R&D organization. The incumbent will serve as functional area head leading nonclinical INDenabling pharmacology activities through early clinical development including nonclinical PK/PD ADME DMPK deliverables to drive FIH dose selection and translational deliverables in nonclinical efficacy and safety characterization using biomarkers. A successful candidate must have demonstrated success in DMPK/ADME IVIVE translational and mechanistic PK/PD modeling and regulatory negotiations as an individual contributor and team leader. Experience in oligonucleotide therapeutics (siRNA antibodyoligo conjugates ASOs) is a must. This role will manage a team of scientists and serve as a SME on programs.The Opportunity to Make a Difference
- Lead Translational Pharmacology team across all modalities (RNA and GT) and therapeutic areas at Sarepta
- Lead the development and of nonclinical PK/PD ADME and DMPK evaluations including strategy development study design and data analyses to inform lead optimization candidate selection and nonclinical drug development
- Lead the strategy development and of translational and mechanistically based PK/PD modeling to enable identification of FIH dose early characterization of efficacy and safety using biomarkers and disease animal models
- Functional SME/lead for global regulatory strategies and regulatory documents including study protocols and reports
- Guide and manage effective communication of data and interpretation to teams and management and contribute as functional SME in departmental and crossdepartmental initiatives
- Represent as functional lead for global regulatory activities and HA engagements (IND 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 DMPK ADME and Translational PK/PD methodologies for RNA and/or GT therapeutics.
- Advocate scientific leadership at external conferences and scientific community.
More about You
- PhD in Pharmaceutical Sciences Pharmacology or related field with 10 years of experience working in biotech or pharmaceutical industry
- Expertise in pharmacology ADME/DMPK IVIVE and translational PK/PD 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
This position is hybrid on site at one of Sareptas facilities in the United States.
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
