Director, Translational Medicine and Early Development (TMED) Lead
Company: Organon
Location: 100% Remote in the US
The Position
As the Director, Translational Medicine and Early Development (TMED) Lead, you will contribute to and develop early clinical and translational medicine strategies for assets within the Organon portfolio. This role includes oversight of phase 1 to 2a study protocols, collaborating with both internal teams (biostatistics, clinical operations) and external partners (CROs, bioanalytical and modeling vendors). You will ensure that study protocols are scientifically sound, based on current literature and regulatory guidance, while serving as the medical monitor and/or study director.
Key Responsibilities
Develop and oversee early development plans (EDP) incorporating biomarker strategies and PK/PD modeling to optimize dose selection and enhance program efficiency.
Represent the TMED function or act as a subject matter expert on asset development teams (ADTs) for early and late-stage development plans.
Lead and participate in ADT sub-team meetings, ensuring collaboration and alignment on project objectives.
Design, execute, and analyze TMED studies in accordance with program plans, collaborating closely with the TMED operations lead and study biostatistician.
Manage vendor selection and oversight for TMED studies, ensuring alignment with internal and external partners.
Author translational medicine and clinical pharmacology components of study protocols, clinical study reports, Investigator Brochures, and regulatory documents.
Provide expertise in responding to health authority inquiries and prepare presentations for governance meetings.
Required Education, Experience, and Skills
MD or PharmD (Post-Doctoral Fellowship preferred).
Board certification in clinical pharmacology is a plus.
In-depth knowledge of drug development and expertise in translational medicine and clinical pharmacology principles, including pharmacometrics and biomarker strategies.
Familiarity with regulatory guidelines relevant to early clinical development and clinical pharmacology.
Strong communication skills, with the ability to convey complex information clearly and effectively.
Collaborative mindset with experience working in cross-functional teams.
Minimum of four years in the pharmaceutical or biotech industry focused on early clinical development or translational medicine.
Preferred Experience
Experience in Women’s Health is strongly preferred.
About Organon
Organon is a $6.5 billion global healthcare company dedicated to women's health and addressing unmet needs. Our vision is to foster better and healthier lives for women everywhere.
Salary Range
The annualized salary range for this position in the U.S. is $150,600 - $256,300, depending on factors such as location and experience.
Additional Information
Organon is an equal opportunity employer, committed to diversity and inclusion.
All applicants must satisfy applicable travel and credentialing requirements.
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Brazil | Sao paulo |Attica :
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