Director, Clinical Pharmacology Lead @9000 Organon LLC

[Hiring] Director, Clinical Pharmacology Lead @9000 Organon LLC

Mar 31, 2025 - 9000 Organon LLC is hiring a remote Director, Clinical Pharmacology Lead. 💸 Salary: $150,600.00 - $256,300.00. 📍Location: USA.

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Role Description

This position can be 100% remote in the US. The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the early clinical development & translational medicine development strategy supporting development assets within the Organon portfolio.

Responsible for the rationale, study design and oversight of phase 1 to 2a study protocols, in collaboration with internal and external partners.
Ensure the scientific and clinical pharmacology components of study protocols are sound, based on the most up-to-date literature and regulatory guidances.
Serve as the medical monitor and/or study director responsible for execution and reporting.
Work collaboratively with cross-functional colleagues in various departments to develop strategic TMED plans.
Facilitate and provide oversight to ensure scientific and data integrity, rigor, and quality.
Represent the TMED function in asset development teams (ADT) across the portfolio.
Responsible for authoring regulatory submission documents and other related materials.

Qualifications

MD or PharmD (Post-Doctoral Fellowship preferred), clinical training preferred.
Board certification in clinical pharmacology a plus.
Excellent working knowledge of drug development, with specific expertise in translational medicine and clinical pharmacology principles.
Good working knowledge of regulatory guidances and requirements pertaining to early clinical development.
Working knowledge of GCP, ICH and other regulatory standards.
Ability to understand and interpret clinical and scientific information and data.
Skillful at technical writing with an ability to summarize clinical and scientific information clearly.
Track record of effective functional representation on product development teams.
Excellent verbal and written communication skills.
Collaborative mindset with a positive, transparent and inclusive approach.
Functional capability with various software platforms including Microsoft Word, PowerPoint, Excel.
A minimum of four years of experience in the pharmaceutical or biotech industry.
Experience in Women’s Health strongly preferred.

Requirements

Participate in or lead ADT sub-team meetings, as appropriate.
Responsible for the design, execution, analysis and interpretation of TMED studies.
Provide input to vendor selection and oversight for TMED studies.
Author translational medicine and clinical pharmacology components of various regulatory documents.
Participate in health authority meetings, as necessary.
Prepare presentations for governance meetings.
Engage and communicate effectively with regulators, scientific leaders, and physicians.

Benefits

Retirement savings plan
Paid vacation and holiday time
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental, and vision coverage

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📍	Be aware of the location restriction for this remote position: USA
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Director, Clinical Pharmacology Lead @9000 Organon LLC

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Salary 💸 $150,600.00 - $256,300.00	Remote Location USA
Job Type full-time	Posted Mar 31, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Director, Clinical Pharmacology Lead @9000 Organon LLC

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