Sr. Manager, Quantitative Clinical Pharmacology

Sarepta Therapeutics; Cambridge (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Sr. Manager in Quantitative Clinical Pharmacology to lead innovative projects in genetic medicine. This role involves advanced modeling and analysis to support drug development decisions, contributing to the understanding of pharmacokinetics and disease progression. The ideal candidate will possess a PhD and a strong background in pharmacometrics, with proficiency in tools like R and NONMEM. Join a forward-thinking organization that values collaboration and integrity, and make a significant impact in the field of rare diseases and gene therapy. If you thrive in a dynamic environment and are passionate about patient outcomes, this opportunity is for you.

Benefits

Physical Wellness Support

Emotional Wellness Support

Financial Wellness Support

Caregiver Support

Qualifications

• PhD in relevant field with 3+ years in clinical pharmacology or pharmacometrics.
• Experience in developing population PK, PK/PD, and disease progression modeling.

Responsibilities

• Perform advanced quantitative pharmacology and pharmacometrics analyses.
• Manage translational and clinical pharmacology efforts with guidance.
• Support regulatory communications and maintain knowledge of best practices.

Skills

Quantitative Pharmacology

Pharmacokinetics (PK)

Pharmacodynamics (PD)

Statistical Analysis

Project Management

Collaboration Skills

Analytical Skills

Communication 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 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

The Importance of the Role

The Sr. Manager, Quantitative Clinical Pharmacology is responsible for providing translational, clinical pharmacology and pharmacometrics deliverables for development assets from pre-IND to Phase III. This incumbent will apply quantitative modeling methodologies inclusive of population PK, PKPD, disease progression modeling using multivariate statistical and empirical approaches to integrate, analyze and interpret diverse data sources (e.g., pharmacokinetics, pharmacodynamics including biomarker & imaging, electronic health records). The Sr. Manager will drive and support pharmacology and pharmacometrics activities involved for dose selection and characterizing the interactions between drugs, patients, and biological systems to identify key predictors.

The Opportunity to Make a Difference

• Perform advanced quantitative pharmacology, pharmacometrics, and disease progression analyses and activities within assigned programs to yield high value population PK, PK/PD, and disease progression modeling support for critical decision making.
• With guidance, manage and develop translational and clinical pharmacology efforts such as study designs, protocol preparation, data analytics, and reporting.
• Co-develop the quantitative clinical pharmacology strategy with guidance and execute or implement strategy with minimum oversight.
• With guidance, support and contribute to regulatory communications and IND/NDA/BLA sections related to clinical pharmacology and pharmacometrics.
• Develop and maintain strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent.
• Develop and maintain scientific awareness and presence in the clinical pharmacology and pharmacometrics discipline, publishes manuscripts and posters, presents at scientific conferences and other scientific forums.
• Perform other related duties as assigned.

More about You

• PhD degree in pharmaceutical sciences, pharmacometrics, biomedical engineering, statistics, applied mathematics, or a related field with a minimum of 3 years of experience working as a clinical pharmacology or pharmacometrician within pharmaceutical industry.
• Experience in developing Population PK, PK/PD, exposure-response, disease progression modeling, and other model based-analyses to aid in research and development decision making.
• Proficiency in R, NONMEM, Phoenix, Monolix or other similar programming languages.
• Experience in ASO, GTx or rare diseases is a plus.
• Knowledge of Health Authority perspective on use of modeling and simulation.
• Excellent interpersonal, collaboration, English communication skills (both written and verbal).
• Strong analytical skills and strategic thinking.
• Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary.
• Self-motivated with strong work ethic and the ability to work independently and efficiently.
• Experience working with stakeholders/partners at all levels, globally, across the organization.

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.