Sr. Manager, Quantitative Clinical Pharmacology

Sarepta Therapeutics; City of Rochester (MA, NY); Remote; USD 132,000 - 165,000; Full time

Job summary

An innovative firm at the forefront of genetic medicine is seeking a Sr. Manager in Quantitative Clinical Pharmacology. This exciting opportunity involves applying advanced modeling methodologies to drive decision-making in drug development. You will play a key role in analyzing diverse data sources and support regulatory communications, contributing to the advancement of therapies for rare diseases. If you are a solution-oriented thinker with a passion for making a difference in patients' lives, this role offers a dynamic environment where your expertise can shine.

Benefits

Physical and Emotional Wellness Programs

Financial Wellness Resources

Support for Caregivers

Competitive Compensation

Work-Life Integration Support

Qualifications

• 3+ years in clinical pharmacology or pharmacometrics required.
• Experience in developing population PK and PK/PD models.
• Strong analytical and strategic thinking skills are essential.

Responsibilities

• Perform advanced quantitative pharmacology and pharmacometrics analyses.
• Manage translational and clinical pharmacology efforts with guidance.
• Support regulatory communications and contribute to IND/NDA/BLA sections.

Skills

Population PK

PKPD Modeling

Disease Progression Modeling

Statistical Analysis

R Programming

NONMEM

Phoenix

Monolix

Project Management

Collaboration Skills

Education

PhD in Pharmaceutical Sciences

PhD in Biomedical Engineering

PhD in Statistics

PhD in Applied Mathematics

Tools

R

NONMEM

Phoenix

Monolix

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 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 supporting them in all aspects of their lives. We aim to maintain a culture that acknowledges people bring their whole selves to work, and we strive to help everyone integrate their work and personal lives while maintaining productivity. Our benefits and work-life resources support areas such as:

• Physical and Emotional Wellness

• Financial Wellness

• Support for Caregivers

For a full list of our benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

The Sr. Manager, Quantitative Clinical Pharmacology, is responsible for delivering translational, clinical pharmacology, and pharmacometrics outputs for development assets from pre-IND to Phase III. This role involves applying quantitative modeling methodologies, including population PK, PKPD, and disease progression modeling, to analyze and interpret diverse data sources such as pharmacokinetics, pharmacodynamics (including biomarkers & imaging), and electronic health records. The Sr. Manager will support pharmacology and pharmacometrics activities essential for dose selection and understanding drug-patient-biological system interactions to identify key predictors.

The Opportunity to Make a Difference

• Perform advanced quantitative pharmacology, pharmacometrics, and disease progression analyses within assigned programs to support decision-making through population PK, PK/PD, and disease progression modeling.
• Manage and develop translational and clinical pharmacology efforts, including study design, protocol development, data analysis, and reporting, with guidance.
• Co-develop and execute the quantitative clinical pharmacology strategy, with minimal oversight.
• Support regulatory communications and contribute to IND/NDA/BLA sections related to clinical pharmacology and pharmacometrics.
• Maintain knowledge of regulatory practices, clinical pharmacology principles, and drug development precedents.
• Contribute to scientific awareness through publications, presentations, and conference participation.
• Perform other related duties as assigned.

More about You

• PhD in pharmaceutical sciences, pharmacometrics, biomedical engineering, statistics, applied mathematics, or related field, with at least 3 years of industry experience in clinical pharmacology or pharmacometrics.
• Experience in developing population PK, PK/PD, exposure-response, and disease progression models to support R&D decisions.
• Proficiency in R, NONMEM, Phoenix, Monolix, or similar software.
• Experience with ASO, GTx, or rare diseases is a plus.
• Knowledge of regulatory perspectives on modeling and simulation.
• Excellent interpersonal, collaboration, and communication skills.
• Strong analytical and strategic thinking skills.
• Proven project management and organizational abilities.
• Self-motivated, with a strong work ethic, capable of working independently.
• Experience working with global stakeholders across the organization.

What Now?

We seek solution-oriented, critical thinkers who are comfortable with ambiguity, relish challenges, and value kindness and integrity in their work and interactions.

#LI-Remote #LI-TD1

This position is remote but may require working on-site at Sarepta's facilities in the U.S. and attending company-sponsored events. The salary range is $132,000 - $165,000, commensurate with experience and other factors. Candidates must be authorized to work in the U.S. Sarepta offers competitive compensation and benefits. We are an Equal Opportunity/Affirmative Action employer and participate in e-Verify.