Position Title: Director, Pharmacometrics Lead
Location: Remote (US-based)
Company Overview: Organon is a global healthcare company delivering innovative health solutions to improve the lives of women, their families, and communities worldwide. With a $6.5 billion portfolio, we focus on advancing women’s health, expanding access to biosimilars, and offering trusted health solutions. Our vision is to foster a better, healthier future for every woman.
Position Summary: The Director, Pharmacometrics Lead, will be responsible for shaping the program-level modeling and simulation strategy. This role includes overseeing vendor selection, managing vendor contracts and onboarding, and providing guidance on the modeling process. The Pharmacometrics Lead will contribute to regulatory submissions and support clinical development programs.
Key Responsibilities:
Lead early clinical development programs, incorporating model-informed drug development (MIDD) strategies and utilizing exposure-response principles for optimal dose selection.
Develop and oversee modeling strategies, including authoring/reviewing analysis plans, outputs, and interpretation.
Collaborate with cross-functional teams to ensure alignment with organizational goals.
Engage with health authorities and contribute to regulatory submissions, including writing modeling summaries for INDs and Investigator Brochures.
Supervise vendor management for outsourced research activities, including vendor selection, contract management, and performance oversight.
Ensure adherence to GLP, GCP, and relevant SOPs.
Provide scientific insight on pharmacokinetics and pharmacometrics for drug development and business opportunities.
Contribute to the development of the Organon product portfolio in line with clinical pharmacology guidelines.
Required Qualifications:
PhD or equivalent in pharmaceutics or related sciences.
Minimum of 5 years’ experience in the pharmaceutical or biotech industry, with expertise in pharmacokinetics, pharmacometrics, and clinical pharmacology.
Proficiency with modeling software such as Phoenix, NONMEM, R, SimCYP, Gastroplus, Monolix, Python, MATLAB, or similar platforms.
Regulatory experience with clinical submission modules and product labels, including interactions with health authorities.
Strong leadership skills with the ability to effectively communicate complex ideas to cross-functional teams.
Experience in vendor management and global project teams.
Preferred Qualifications:
Experience in Women’s Health.
Additional Information:
Salary Range (US): $150,600 - $256,300 annually
Benefits: Includes retirement savings, paid vacation, medical benefits, and more.
Work Arrangements: 100% remote.
VISA Sponsorship: Not available.
Commitment to Diversity: Organon values diversity and is committed to providing equal opportunities for all employees. We welcome applicants from all backgrounds and identities.
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