We have a current opportunity for a Director Pharmacometrics on a permanent basis. The position will be a hybrid based role in Pennsylvania. For further information about this position please apply.
Job Title: Director of Pharmacometrics
Location: Pennsylvania, USA
Company: Mid Sized Pharma
Job Type: Full-Time
Job Summary: We are seeking a highly skilled and experienced Director of Pharmacometrics to lead our pharmacometrics team. The successful candidate will be responsible for developing and implementing pharmacometric strategies to support drug development programs, from early discovery through late-stage clinical development and regulatory submissions.
Key Responsibilities:
- Lead and manage the pharmacometrics team, providing strategic direction and mentorship.
- Develop and implement pharmacometric modeling and simulation strategies to support drug development programs.
- Collaborate with cross-functional teams, including clinical pharmacology, biostatistics, regulatory affairs, and clinical development, to ensure alignment of pharmacometric activities with overall project goals.
- Conduct population pharmacokinetic (PK) and pharmacodynamic (PD) analyses, exposure-response modeling, and clinical trial simulations.
- Provide and implement constructive collaboration within development teams and other internal partners (ex: , Regulatory Affairs, DMPK, Clinical Development, and Biostatistics).
- Prepare and review pharmacometric reports and regulatory submission documents.
- Represent the company in interactions with regulatory agencies and external stakeholders.
- Stay current with advancements in pharmacometric methodologies and software tools.
- Contribute to the development of best practices and standard operating procedures for pharmacometric analyses.
Qualifications:
- Ph.D. in Pharmacometrics, Pharmacokinetics, Clinical Pharmacology, or a related field.
- Minimum of 10 years of experience in pharmacometrics within the pharmaceutical or biotechnology industry.
- Proven track record of leading pharmacometric teams and successfully supporting drug development programs.
- Expertise in population PK/PD modeling, exposure-response analyses, and clinical trial simulations.
- Proficiency in pharmacometric software tools such as NONMEM, Monolix, R, and MATLAB.
- Strong understanding of regulatory requirements and guidelines related to pharmacometrics.
- Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
- Strong problem-solving skills and the ability to think critically and strategically.
Benefits:
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan with company match.
- Generous paid time off and holidays.
- Professional development opportunities.
- Relocation assistance, if applicable.
