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Job type: Permanent

Discipline: Pharmacovigilance

Location: United States

Director of Pharmacometrics - Permanent - Remote US

Shape your future with the freedom to work where you thrive! Join our client with this Director position that fits your life.

��Ƶ is seeking a Director of Pharmacometrics to lead and manage a team within the Quantitative Medicine Program.

Primary Responsibilities:

In this role, you will collaborate with cross-functional teams and external partners to design and implement modeling and simulation strategies that support drug development. You will play a key role in optimizing dosing regimens, study designs, and regulatory submissions through quantitative methods. This position requires expertise in clinical pharmacology, pharmacometrics, and regulatory practices.

Skills & Requirements:

Strong understanding of pharmacokinetics (PK), pharmacodynamics (PD), and pharmacology relevant to drug development.
Familiarity with clinical trial phases, mixed-effects models, survival analyses, and model-based meta-analyses.
Knowledge of FDA, EMA, and PMDA regulatory requirements.
Proficiency with quantitative software such as NONMEM, R, Simcyp, Monolix, or Phoenix WinNonLin.
Excellent time management, problem-solving, and analytical skills.
Proven ability to prioritize, delegate, and manage multiple projects effectively.
Strong verbal and written communication skills in English.
Advanced degree (PharmD or PhD) in a relevant field.
Experience in drug development, clinical pharmacology, or regulatory affairs within the pharmaceutical or biotech industry.
Demonstrated scientific contributions through publications in Clinical Pharmacology and Pharmacometrics.

The Director of Pharmacometrics' responsibilities will be:

Lead and manage a Pharmacometrics team within the Quantitative Medicine Program.
Provide expertise in pharmacometrics, including analysis and regulatory-compliant data structures.
Represent MIDD on cross-functional teams, supporting internal decisions and regulatory contributions.
Plan and direct clinical pharmacology and modeling components of development programs.
Collaborate with internal and external stakeholders to design, conduct, and report clinical pharmacology and modeling activities.
Develop and implement modeling strategies aligned with industry best practices.
Apply quantitative methods to integrate pharmacokinetics, pharmacodynamics, patient characteristics, and disease status.
Summarize and interpret data analyses to inform quantitative drug development tools.
Prepare scientific summaries and reports for regulatory interactions, submissions, and publications.
Provide leadership in quantitative medicine aspects of regulatory submissions.
Develop novel modeling methodologies and establish platforms to improve development timelines and efficiency.

Compensation:

$210,000 to $214,900 per annum.

If you are having difficulty in applying or if you have any questions, please contact Jakub Hanas at j.hanas@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��Ƶ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��Ƶ is acting as an Employment Agency in relation to this vacancy.

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