Job Title: Director of Clinical Pharmacometrics
Job Type: Full-Time
Location: New Jersey
We're representing a 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.
