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    Director, Clinical Pharmacology Lead

    Organon
    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

    1. 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).

    2. 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.

    3. 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.

    4. 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.

    5. 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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