Director Pharmacometrician - EPM Scientific

Job Title: Director of Clinical Pharmacometrics

Job Type: Full-Time

Location: New Jersey

We're representinga leading biopharmaceutical company dedicated to discovering and developing innovative medicines that improve patient outcomes. We are committed to advancing the science of pharmacometrics to support drug development and regulatory decision-making.

Position Summary: We are seeking a highly skilled and experienced Director of Clinical Pharmacometrics to lead our pharmacometrics team. The successful candidate will play a critical role in developing and implementing quantitative modeling strategies to support clinical drug development programs. You will oversee all pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions.

This position requires a deep understanding of pharmacokinetics (PK), pharmacodynamics (PD), and disease progression modeling.

Key Responsibilities:

• Lead and manage the clinical pharmacometrics team, providing strategic direction and mentorship.
• Develop and implement quantitative modeling strategies to support clinical drug development.
• Collaborate with cross-functional teams, including clinical development, biostatistics, regulatory affairs, and medical writing.
• Interacts with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies.
• Design and conduct population PK/PD analyses, exposure-response modeling, and disease progression modeling.
• Interpret and communicate modeling results to internal and external stakeholders
• Manage pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.
• Contribute to the preparation of regulatory submissions and responses to regulatory agencies.
• Stay current with advancements in pharmacometrics and modeling methodologies.
• Publish research findings in peer-reviewed journals and present at scientific conferences.

Qualifications:

• Ph.D. in Pharmacometrics, Pharmacokinetics, Pharmacology, or a related field.
• Minimum of 8 years of experience in clinical pharmacometrics, with a strong emphasis on modeling.
• Proven track record of leading and managing a team of pharmacometricians.
• Extensive experience with population PK/PD modeling, exposure-response modeling, and disease progression modeling.
• Proficiency in modeling software such as NONMEM, Monolix, or similar tools.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively in a fast-paced, dynamic environment.

Preferred Qualifications:

• Experience in regulatory interactions and submissions.
• Strong publication record in peer-reviewed journals.
• Familiarity with advanced modeling techniques such as machine learning

Benefits:

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company match.
• Generous paid time off and holiday schedule.
• Professional development opportunities.