Director, Clinical Pharmacology
Organon
full-time
Posted on:
Location Type: Office
Location: Plymouth Meeting • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $152,300 - $259,200 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Contribute to and devise clinical pharmacology strategy supporting Organon development assets
- Design, provide rationale for, and oversee phase 1 to 2a study protocols in collaboration with internal and external colleagues
- Serve as medical monitor and/or study director responsible for execution and reporting of TMED studies
- Develop strategic early development plans (EDP) integrating PK/PD modeling, exposure-response relationships, and biomarker strategy to optimize dose selection
- Provide vendor selection input and vendor oversight (CROs, bioanalytical, modeling vendors)
- Author translational medicine and clinical pharmacology components of protocols, clinical study reports, Investigator Brochures, IND subsections, submission modules, briefing books, and regulatory responses
- Participate in health authority meetings and prepare TMED presentations for governance
- Collaborate across preclinical science, data science, clinical operations, regulatory affairs, CMC, project management and other partner groups
- Attend and actively participate in asset development and sub-team meetings, clinical study teams, modeling and vendor meetings
- Contribute to scientific communication and events and engage with regulators, scientific leaders, and physicians as needed
Requirements
- MD or PharmD (Post-Doctoral Fellowship preferred), clinical training preferred
- Board certification in clinical pharmacology a plus
- A minimum of six years of experience in the pharmaceutical or biotech industry with a focus in early clinical development, translational medicine and/or clinical pharmacology
- Post-doctoral, industry-sponsored PharmD Fellowship strongly preferred (for PharmD candidates)
- Experience in Women’s Health strongly preferred
- Extensive working knowledge of small molecule drug development and translational medicine and clinical pharmacology principles including pharmacometrics, drug metabolism and human ADME, biomarkers, exposure-response assessment, and biopharmaceutics
- Demonstrated technical and scientific knowledge of pharmacokinetics, pharmacometrics, and clinical pharmacology disciplines
- Good working knowledge of regulatory guidance for early clinical development, exposure-response analysis, PK/PD modeling, and nonclinical and biopharmaceutics guidelines
- Working knowledge of GCP, ICH and other regulatory standards
- Ability to understand and interpret clinical and scientific information and communicate it appropriately
- Skillful technical writing and ability to summarize clinical and scientific information
- Functional capability with Microsoft Word, PowerPoint, Excel
- Must satisfy travel and credentialing requirements, including associated vaccination prerequisites
- US and PR Residents Only
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 in accordance with the terms and conditions of the applicable plans
- Flexible Work Arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical pharmacologytranslational medicinepharmacokineticspharmacometricsdrug metabolismhuman ADMEbiomarkersexposure-response assessmentbiopharmaceuticsPK/PD modeling
Soft skills
technical writingcommunicationcollaborationscientific communicationorganizational skills
Certifications
MDPharmDBoard certification in clinical pharmacology