Senior Director – Quantitative Clinical Pharmacology & Pharmacometrics

Sarepta Therapeutics; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player in genetic medicine is seeking a Senior Director of Clinical Pharmacology and Pharmacometrics. This pivotal role involves leading a high-performing team, driving innovative strategies in drug development, and ensuring regulatory success. The ideal candidate will possess extensive experience in clinical pharmacology, a track record of successful regulatory interactions, and a passion for mentoring. Join a forward-thinking organization dedicated to making a difference in the lives of patients with rare diseases. If you are a solution-oriented leader with a commitment to excellence, this opportunity is for you.

Benefits

Physical and Emotional Wellness Support

Financial Wellness Resources

Caregiver Support

Qualifications

• PhD in Clinical Pharmacology or related field with ≥ 10 years in biotech/pharma.
• Strong expertise in clinical pharmacology and proven regulatory success.

Responsibilities

• Lead clinical pharmacology and pharmacometrics team in neuromuscular diseases.
• Develop and execute pharmacometrics strategies across drug development.

Skills

Clinical Pharmacology

Pharmacometrics

Data Analytics

Regulatory Interactions

Team Leadership

Communication Skills

Education

PhD in Clinical Pharmacology

Pharmaceutical Sciences

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

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 Clinical Pharmacology and Pharmacometrics 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, Translational Pharmacology, QSP and Data Analytics, as well as cross-functionally across the R&D organization. The incumbent will serve as a therapeutic area lead in neuromuscular diseases and will enhance the existing capabilities and talents in a high-performing Clinical Pharmacology and Pharmacometrics team. A successful candidate must have a demonstrated track-record of driving success in clinical pharmacology, MIDD, and regulatory negotiations as an individual contributor and team leader.

This leadership role will be developing and executing clinical pharmacology and pharmacometrics strategies and deliverables from early through late-stage clinical development. Key areas of emphasis will include but are not limited to clinical dose selection and refinement across all phases of clinical development, FIH and clinical pharmacology study designs, development and hands-on application of MIDD using population and statistically based methodologies, as well as mechanistic and translational PK/PD approaches. This role will manage a team of scientists and serve as a SME on programs.

The Opportunity to Make a Difference

Primary Responsibilities Include:

• Lead clinical pharmacology and pharmacometrics team in neuromuscular diseases (rare disease drug development experience preferred)
• Represent as therapeutic lead and SME in clinical pharmacology strategies, clinical study protocol preparation, study execution, data review/analysis, and study reports
• Lead the development and execution of pharmacometrics strategies across all stages of drug development through product registration
• Lead and execute model-based data analyses including population PK, PK/PD modeling and simulations, meta-analysis, disease modeling to inform clinical development
• Represent as functional lead for global regulatory activities and HA engagements (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 clinical pharmacology and pharmacometrics discipline, publish manuscripts, advocate scientific leadership at external conferences and scientific community.

More about You

Education and Skills Requirements:

• PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or related field with ≥ 10 years of experience working in biotech or pharmaceutical industry
• Expertise in clinical pharmacology and pharmacometrics 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, multitasking, and collaboration skills in cross-functional and matrixed team environments

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.