Job Description
Position: Director, Pharmacometrics Lead
Location: 100% Remote in the US
Overview
The Director, Pharmacometrics Lead, will be responsible for creating and overseeing the program-level modeling and simulation strategy. This includes selecting suitable modeling vendors and serving as the primary point of contact, collaborating with procurement and vendor management for contracting and onboarding. The role entails oversight of the modeling process, coordinating cross-functional discussions, and reviewing technical aspects of modeling efforts and reports.
Additionally, the Pharmacometrics Lead will contribute to and review clinical modules for regulatory submissions, author and review key regulatory documents, including Investigator Brochures and INDs. They will serve as the primary author for modeling summaries in regulatory submissions.
Responsibilities
Modeling Strategy: Lead early clinical development programs, collaborating with Asset Development Teams (ADTs) to implement model-informed drug development (MIDD) strategies. Focus on optimizing dose selection and assessing pharmacokinetic profiles, including population pharmacokinetic (PopPK) assessments.
Content Development: Author, review, and approve modeling and simulation analysis plans, and interpret key findings for presentations.
Regulatory Interactions: Engage with Health Authorities as needed, ensuring adherence to Good Laboratory Practices (GLP) and Good Clinical Practice (GCP).
Communication: Effectively communicate with regulators, scientific leaders, and physicians.
Required Education, Experience, and Skills
PhD or equivalent degree in pharmaceutics or a related field.
Minimum of five years of experience in the pharmaceutical or biotech industry with expertise in pharmacokinetics, pharmacometrics, and clinical pharmacology.
Proficient in relevant software such as Phoenix, NONMEM, R, SimCYP, Gastroplus, Monolix, Python, or MATLAB.
Experience preparing clinical submission modules and interacting with regulatory agencies.
Preferred Experience and Skills
Experience in Women’s Health is strongly preferred.
Who We Are
Organon is a $6.5 billion global healthcare company dedicated to making a positive impact on women’s health. Our vision is clear: to create a better and healthier every day for every woman. We invest in addressing the unmet needs of Women's Health and expanding access to essential health solutions.
Additional Information
Salary Range: $150,600 - $256,300 (US)
Employee Status: Regular
Relocation: Not applicable
VISA Sponsorship: Not available
Organon is committed to diversity and equal opportunity for all employees and applicants, regardless of race, color, religion, gender identity, sexual orientation, age, disability, or any other characteristic protected by law.
For more details about personal rights under Equal Employment Opportunity, please visit the EEOC website.
Note: Unsolicited assistance from search firms will not be accepted. All candidates must comply with travel and credentialing requirements, including vaccination prerequisites.
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