Director, Quantitative Clinical Pharmacology: PK/PD Modeling & Strategy

Sarepta Therapeutics; Connecticut; Hybrid; USD 186,000 - 232,000; Full time

Benefits offered by this job

Physical Wellness

Financial Wellness

Caregiver Support

Job summary

Sarepta Therapeutics in the United States is seeking a Director of Quantitative & Clinical Pharmacology to lead pharmacology and pharmacometrics across early through late-stage development, with emphasis on dose selection and PK/PD modeling.

The role drives model-based analyses (population PK, PK/PD, meta-analysis) and serves as the functional lead for global regulatory strategies and HA engagements, collaborating across translational teams and regulatory bodies.

Qualifications

• PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years in clinical pharmacology or pharmacometrics.
• Strong understanding of clinical pharmacology principles and hands-on PK/PD modeling.
• Experience interacting with regulatory agencies and clinical development teams.
• Excellent communication, multitasking, and collaboration skills.

Responsibilities

• Lead quantitative pharmacology strategies across all stages from development to registration.
• Provide clinical pharmacology expertise in translational development, protocol prep, execution, and data review.
• Model-based analyses including population PK, PK/PD modeling, meta-analysis, and disease modeling.
• Serve as functional lead for global regulatory strategies and HA engagements.

Skills

PK/PD modeling

Regulatory interactions

Communication

Multitasking

Collaboration

Education

PhD in Pharmaceutical Sciences

Mathematics/Engineering related field

Tools

NONMEM

R

Job description

Why Sarepta? Why Now?

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. 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 Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Ph3 and product registration), with an emphasis on clinical dose selection/refinement and predictive PK/PD modeling inclusive of population and statistically-based methodologies, as well as mechanistic and translational-focused approaches. This is a highly visible and team-facing role.

The Opportunity to Make a Difference

• Drives the development and execution of the 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 execution, data review/analysis, study reports

• Responsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to inform clinical development
• Serves as functional lead for global regulatory strategies and HA engagements

• Maintains leading-edge 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 7 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

• Excellent communication, multitasking, and collaboration skills
• Experience in NONMEM & R highly preferred
• siRNA and/or CNS experience is preferred

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.

#LI-HybridThis position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $185,600 - $232,000 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.