Sr. Manager, Quantitative Clinical Pharmacology

Sarepta Therapeutics, Inc.; Cambridge (MA); Hybrid; USD 132,000 - 165,000; Full time

Job summary

An established industry player is seeking a Sr. Manager in Quantitative Clinical Pharmacology to lead innovative pharmacometrics efforts. This role involves applying advanced quantitative modeling methodologies to support drug development from pre-IND to Phase III. You will collaborate with cross-functional teams, contribute to regulatory communications, and drive impactful analyses that inform critical decision-making. Join a dynamic team committed to transforming the landscape of genetic medicine and make a significant difference in the lives of patients. If you're a solution-oriented thinker with a passion for science, this opportunity is for you.

Benefits

Comprehensive Benefits

Work-Life Resources

Support for Caregivers

Physical and Emotional Wellness Programs

Financial Wellness Programs

Qualifications

• PhD with 3+ years in clinical pharmacology or pharmacometrics in pharma.
• Experience in 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 related to clinical pharmacology.

Skills

Quantitative Modeling

Population PK

PKPD Analysis

Statistical Analysis

Interpersonal Skills

Analytical Skills

Project Management

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:

1. Physical and Emotional Wellness
2. Financial Wellness
3. 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 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

1. 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.
2. With guidance, manage and develop translational and clinical pharmacology efforts such as study designs, protocol preparation, data analytics, and reporting.
3. Co-develop the quantitative clinical pharmacology strategy with guidance and execute or implement strategy with minimum oversight.
4. With guidance, support and contribute to regulatory communications and IND/NDA/BLA sections related to clinical pharmacology and pharmacometrics.
5. Develop and maintain strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent.
6. 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.
7. Perform other related duties as assigned.

More about You

1. 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.
2. 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.
3. Proficiency in R, NONMEM, Phoenix, Monolix or other similar programming languages.
4. Experience in ASO, GTx or rare diseases is a plus.
5. Knowledge of Health Authority perspective on use of modeling and simulation.
6. Excellent interpersonal, collaboration, English communication skills (both written and verbal).
7. Strong analytical skills and strategic thinking.
8. 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.
9. Self-motivated with strong work ethic and the ability to work independently and efficiently.
10. 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.

#LI-Remote

#LI-TD1

This position is remote. However, 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 $132,000 - $165,000 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.