Director, Clinical Pharmacology
Organon
Google Cloud Platform
Associate Director, Biopharmaceutics
Organon
full-time
Posted on:
Location Type: Office
Location: Plymouth Meeting • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $125,400 - $213,100 per year
Job Level
Senior
About the role
- Provide expert biopharmaceutical guidance on the pharmacokinetic performance of drug products
- Support the Biopharmaceutics Lead on early clinical development programs
- Design bioavailability/ bioequivalence study synopsis
- Interpret study results and review protocols and reports
- Identify formulation-related considerations
- Contribute to scientific communications and internal knowledge-sharing events
- Support interactions with Health Authorities
- Engage with regulators and stakeholders as needed
Requirements
- PhD or equivalent degree in pharmaceutics, pharmaceutical sciences, biopharmaceutics, or related discipline
- Minimum of 3 years of experience in the pharmaceutical or biotech industry
- Demonstrated technical and scientific knowledge of pharmacokinetics, formulation development and biopharmaceutics, and clinical pharmacology
- Working knowledge of early clinical development and clinical pharmacology-, modeling- and bioanalytical-related regulatory guidelines and GxP requirements
- Regulatory experience including the preparation of submission modules, briefing books and/or product labeling
- Excellent organizational and interpersonal skills
- Ability to process and articulate complex ideas clearly
- Ability to prioritize and provide solution-oriented recommendations
- Experience with management and oversight of vendors supporting outsourced research activities
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacokineticsformulation developmentbiopharmaceuticsclinical pharmacologybioavailability study designbioequivalence study designregulatory submission preparationbioanalytical methodsGxP compliancemodeling
Soft skills
organizational skillsinterpersonal skillscommunication skillsproblem-solvingprioritizationsolution-oriented thinkingcollaborationknowledge sharingstakeholder engagementarticulation of complex ideas
Certifications
PhD in pharmaceuticsPhD in pharmaceutical sciencesPhD in biopharmaceutics