Job Description
The Position
This position can be 100% remote in the US
The Director, Translational Medicine and Early Development (TMED) Lead is responsible for shaping the early clinical development and translational medicine strategy for Organon’s development assets. This role involves designing and overseeing phase 1 to 2a study protocols, collaborating with internal teams (like biostatistics and clinical operations) and external partners (such as CROs and bioanalytical vendors). The TMED Lead ensures that study protocols are scientifically sound and compliant with the latest literature and regulatory guidelines, supporting approved early development plans. Additionally, the TMED Lead serves as the medical monitor or study director for execution and reporting.
The Director will work closely with cross-functional teams—including preclinical science, data science, regulatory affairs, and project management—to develop integrated early development plans (EDP) that utilize clinical pharmacology principles, such as exposure-response relationships, to optimize dose selection and enhance program efficiency. The TMED Lead may also represent the TMED function in asset development teams (ADT) across the portfolio.
Key responsibilities include authoring regulatory submission modules, Investigator Brochures, IND subsections, briefing books, and responding to agency inquiries.
Responsibilities
Required Education, Experience and Skills
Preferred Experience and Skills
Who We Are
Organon delivers innovative health solutions that enable individuals to live their best lives. As a $6.5 billion global healthcare company, we focus on making a difference for women and their families. Our vision is clear: a better and healthier everyday for every woman.
Additional Information
Organon embraces diversity and is committed to equal opportunity in employment for all employees and job applicants.
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