Director, Translational Medicine And Early Development (Clinical Pharmacology Lead)

Organon

7+ years

$150,600.00 - $256,300.00 (U.S.)

Plymouth Meeting Remote, USA

10 Oct. 16, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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

Develop early development plans that include biomarker strategies and leverage PK/PD modeling for optimized dose selection.
Represent the TMED function or serve as a subject matter expert on ADTs for early clinical development (first-in-man to Phase 2a) and lifecycle management (LCM) for mature products.
Design, execute, analyze, and interpret TMED studies, collaborating with study teams and overseeing vendor management.
Author the clinical pharmacology components of study protocols, reports, and regulatory documents.
Lead responses to health authority questions and participate in health authority meetings as needed.
Prepare presentations for governance meetings and contribute to scientific communication efforts.

Required Education, Experience and Skills

MD or PharmD (Post-Doctoral Fellowship preferred).
Board certification in clinical pharmacology is a plus.
Strong knowledge of drug development, with expertise in translational medicine and clinical pharmacology principles.
Familiarity with regulatory guidelines for early clinical development, including GCP and ICH standards.
Ability to interpret and communicate complex clinical and scientific information clearly.
Minimum of four years of experience in the pharmaceutical or biotech industry, focusing on early clinical development and translational medicine.

Preferred Experience and Skills

Experience in Women’s Health is strongly preferred.

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

Salary Range: $150,600.00 - $256,300.00 (U.S.)
Employee Status: Regular
Relocation: No relocation offered
VISA Sponsorship: Not available
Flexible Work Arrangements: Available

Organon embraces diversity and is committed to equal opportunity in employment for all employees and job applicants.

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Director, Translational Medicine And Early Development (Clinical Pharmacology Lead)

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