Director, Clinical Pharmacology Lead

4+ years

$150,600.00 - $256,300.00

Boston California Jersey City North Carolina Plymouth Meeting

10 Nov. 24, 2024

Job Description

Job Type: Full Time Education: MD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Director, Translational Medicine and Early Development (TMED) Lead

Position Overview

Location: 100% Remote (US-based)
Job Type: Regular
Travel Requirements: Must meet applicable travel and credentialing requirements, including vaccination prerequisites.
Relocation: Not provided.
Salary Range (US): $150,600 – $256,300 annually
Reports To: Senior Leadership

The Director, Translational Medicine and Early Development (TMED) Lead, will oversee early clinical and translational medicine strategies for Organon's development portfolio. This includes phase 1 to 2a study design, execution, and reporting, while ensuring adherence to scientific rigor and regulatory standards.

The role requires cross-functional collaboration to create integrated Early Development Plans (EDPs) that incorporate clinical pharmacology principles, biomarker strategies, and pharmacokinetic/pharmacodynamic (PK/PD) modeling to optimize drug development efficiency.

Key Responsibilities

Strategic Development & Oversight
- Develop and implement EDPs for assets from first-in-human to Phase 2a.
- Optimize dose selection and program efficiency via biomarker strategies and PK/PD modeling.
- Represent TMED in Asset Development Teams (ADTs) for drug candidates, late-stage plans, or lifecycle management (LCM).
Clinical Study Management
- Design, execute, analyze, and interpret TMED studies.
- Collaborate with TMED Operations Leads, biostatisticians, and external vendors (CROs, bioanalytical/modeling vendors) for successful study execution.
- Serve as medical monitor or study director for early clinical trials.
Regulatory Submissions
- Author modules 2.7.1, 2.7.2, and contribute to 2.7.3, 2.7.4, 2.5, and labeling for submissions.
- Develop Investigator Brochures, IND subsections, briefing books, and agency responses.
- Engage with regulators during meetings as needed.
Cross-Functional Collaboration
- Work closely with internal teams (preclinical, data science, regulatory, CMC, clinical operations).
- Participate in governance, sub-team, and scientific meetings.
- Ensure data integrity and quality in all deliverables.
Scientific Communication
- Present TMED strategies and outcomes to internal and external stakeholders.
- Contribute to scientific publications, events, and conferences.

Qualifications

Education & Training:

MD or PharmD (post-doctoral fellowship preferred); clinical training desired.
Board certification in clinical pharmacology is a plus.

Experience:

Minimum 4 years in pharmaceutical/biotech industry with early clinical development, translational medicine, or clinical pharmacology focus.
Industry-sponsored post-doctoral fellowship strongly preferred (for PharmD candidates).
Experience in Women’s Health is strongly preferred.

Technical Expertise:

Strong knowledge of:
- Drug development, clinical pharmacology, and PK/PD modeling.
- Biomarkers, pharmacometrics, drug metabolism, exposure-response assessments.
- Regulatory guidelines (GCP, ICH) and clinical pharmacology standards.
Functional proficiency in software such as Microsoft Word, Excel, PowerPoint.

Skills:

Exceptional technical writing and verbal communication skills.
Effective collaborator with cross-functional teams.
Strong data interpretation and presentation capabilities.
Proven track record of functional representation in product development teams.

Company Overview

Organon is a $6.5 billion global healthcare company focused on delivering innovative solutions in Women’s Health, biosimilars, and a diverse portfolio of trusted health solutions. Organon values diversity and equal opportunity, providing a supportive environment for career growth and development.

Employment Notes

Diversity Commitment: Organon is an equal opportunity employer committed to inclusivity.
Search Firm Policy: Unsolicited CVs from search firms will not be considered without a pre-existing agreement.

For more details on Equal Employment Opportunity rights, please review:

EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule

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Director, Clinical Pharmacology Lead

Job Description

Job Description: Director, Translational Medicine and Early Development (TMED) Lead

Position Overview

Key Responsibilities

Qualifications

Company Overview

Employment Notes

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