We are seeking a Senior Manager to drive PK/TK analysis supporting both preclinical and clinical programs. This role is perfect for a PhD/PharmD professional who enjoys a mix of hands-on technical work and strategic project leadership.
location: Warren, New Jersey
job type: Permanent
salary: $135,000 - 150,000 per year
work hours: 9 to 5
education: Doctorate
responsibilities:
- End-to-End PK/PD Leadership: Lead the design, execution, and analysis of non-compartmental (NCA) pharmacokinetic and toxicokinetic studies, bridging the gap between discovery research and clinical development.
- Strategic Regulatory Contribution: Drive the preparation of critical regulatory components, including IND/NDA submissions, study protocols, and clinical pharmacology analysis plans to ensure alignment with global health authority standards.
- Vendor & CRO Management: Act as the primary technical lead for external partnerships, overseeing Contract Research Organizations (CROs) to ensure the high-quality delivery of outsourced PK/PD and exposure-response analyses.
- Advanced Data Stewardship: Manage the lifecycle of clinical pharmacology data using industry-standard tools like Phoenix WinNonlin, DS Integral, and PK Submit, ensuring 100% data integrity and QA/QC compliance.
- Cross-Functional Collaboration: Serve as the Clinical Pharmacology subject matter expert (SME) in matrixed teams, influencing project strategy across Clinical Operations, Medical Writing, and Regulatory Affairs.
qualifications:
Education:
- PhD. or PharmD.
- Hands-on experience with non-compartmental (NCA) PK analysis to support preclinical and clinical pharmacokinetic/toxicokinetic studies.
- Proficiency with PK analysis software packages (such as Phoenix WinNonlin).
- Demonstrated experience in writing study reports and regulatory documents.
- Excellent planning, organization and time management skills, including the ability to support and prioritize multiple projects.
skills: Pharmacology, DMPK, PKPD, Pharmacokinetics (PK), Pharmacology and Toxicology Principles
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
