Senior Director, Translational Pharmacology

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 limb-girdle 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.
 

We’re 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 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
 

The 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 patient-centric mission, scientific innovation and expanding pipeline in precision genetic therapies. This is a highly visible, team-facing and leadership position that will partner closely with two other groups within QCP, Clinical Pharmacology & Pharmacometrics, QSP & Data Analytics, as well as cross-functionally across the R&D organization. The incumbent will serve as functional area head leading nonclinical IND-enabling 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, antibody-oligo 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 execution of non-clinical PK/PD, ADME and DMPK evaluations including strategy development, study design and execution, data analyses to inform lead optimization, candidate selection and nonclinical drug development
• Lead the strategy, development and execution 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 cross-departmental 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 high-performing scientists
• Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications
• Encompass leading-edge 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 hands-on experience in modeling and data analytics, and proven success in regulatory interactions from IND through registration
• Demonstrated success in leading and building high-performing teams, with a strong commitment to people development
• Excellent communication, mu