1 день назад
Director, Pharmacometrics, Clinical Pharmacology (Pharmaceuticals)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Director, Pharmacometrics, Clinical Pharmacology (Pharmaceuticals): Leading the design and execution of modeling and simulation approaches for drug development programs with an accent on MIDD, PK/PD, and regulatory strategy. Focus on shaping dose selection and trial design for therapies targeting rare diseases.
Location: Must be based in the United States
Company
A pharmaceutical partner company focusing on the development of therapies for rare diseases.
What you will do
- Develop and execute end-to-end modeling and simulation strategies across early- and late-stage clinical development programs.
- Lead PK/PD, population PK, exposure-response, and disease progression modeling activities.
- Define pharmacometric strategies for regulatory submissions, including dose justification and trial design support.
- Act as the subject matter expert and scientific authority in Model-Informed Drug Development (MIDD).
- Collaborate with clinical and regulatory teams to integrate modeling outputs into broader development plans.
- Guide exploratory and advanced modeling approaches, including QSP and empirical frameworks.
Requirements
- PhD or PharmD in Pharmaceutical Sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering, or related field.
- 6+ years of relevant industry experience in pharmacometrics and model-based drug development.
- Strong expertise in NLME methods, population PK/PD modeling, and clinical trial simulation.
- Hands-on experience with NONMEM and R.
- Deep understanding of clinical pharmacology principles and rare disease therapeutic areas.
- Must be based in the United States.
Culture & Benefits
- Competitive base salary with short-term and long-term incentive compensation, including equity.
- Comprehensive medical, dental, and vision insurance for employees and dependents.
- Retirement savings plan with employer matching contributions.
- Generous paid time off and flexible vacation policies.
- Flexible work arrangements with a remote-based structure.
- Wellness programs and employee support resources.
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