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Director, Clinical Pharmacology Lead

10 Nov. 15, 2024
Job Description
Job Type: Full Time 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

The Position

The Director, Translational Medicine and Early Development (TMED) Lead will contribute to or develop the early clinical development and translational medicine strategies supporting assets within the Organon portfolio. The TMED Lead will also oversee the rationale, study design, and phase 1-2a study protocols, in collaboration with internal (biostatistics, clinical operations) and external partners (CROs, bioanalytical vendors). This role ensures that the clinical pharmacology components of study protocols are scientifically sound, based on the latest literature and regulatory guidance.

The TMED Lead will act as a medical monitor and/or study director for study execution and reporting in collaboration with the TMED Operations Lead. They will work closely with cross-functional colleagues to develop integrated early development plans that incorporate clinical pharmacology principles and accelerate the development process.

The Director may represent the TMED function in asset development teams (ADT) or for lifecycle management of mature products. They will also contribute to authoring critical regulatory documents and preparing presentations for governance meetings.


Key Responsibilities

  • Develop early development plans integrating biomarker strategies, PK/PD modeling, and exposure-response relationships to optimize dose selection and expedite program development.
  • Represent the TMED function or serve as a subject matter expert on asset development teams (ADT).
  • Oversee the design, execution, analysis, and interpretation of TMED studies in line with program objectives.
  • Author study protocols, clinical study reports, Investigator Brochures, and regulatory submission documents.
  • Lead responses to health authority inquiries and regulatory questions.
  • Collaborate with internal and external stakeholders to manage vendor relationships and ensure study quality.

Required Education, Experience, and Skills

  • Education: MD or PharmD (Post-doctoral fellowship preferred)
  • Experience: At least 4 years in pharmaceutical or biotech industry, specializing in early clinical development, translational medicine, or clinical pharmacology.
  • Skills:
    • Expertise in drug development, translational medicine, pharmacometrics, drug metabolism, biomarkers, and clinical pharmacology.
    • Knowledge of regulatory guidelines (GCP, ICH, etc.).
    • Ability to effectively communicate clinical and scientific information.
    • Proficient in Microsoft Office (Word, PowerPoint, Excel).

Preferred Experience

  • Post-doctoral, industry-sponsored PharmD Fellowship.
  • Experience in Women’s Health.

Who We Are

Organon is a global healthcare company focused on delivering innovative health solutions for women and their families. We invest in meeting the unmet needs in Women's Health and strive to improve global access to health solutions. Join us in our mission for a healthier tomorrow.


Salary Information

  • US Salary Range: $150,600.00 - $256,300.00 (Annualized)
  • Benefits: Comprehensive healthcare, retirement savings, paid leave, and more.

This job description is intended to convey the general nature and level of work being performed by the individual in this role. This is not an exhaustive list of all responsibilities and tasks that may be required.