Mallinckrodt Pharmaceuticals Bedminster , NJ 07921
JR000008834 Clinical Pharmacologist (Open)
US Specialty Brand Headquarters - USA501
Mallinckrodt is seeing an enthusiastic, creative and highly motivated Clinical Pharmacologist to join the Clinical Pharmacology group at our US headquarters in Bedminster, NJ. The Clinical Pharmacologist is a highly scientific role, reporting to the Sr. Director, Clinical Pharmacology. The main responsibility of this role is to provide the support to the projects on all clinical pharmacology related issues, including study design such as dosing selection, PK/PD analyses, and reporting. This position is also the scientific and medical/clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), medical affairs, commercial, etc.
As an employee of Mallinckrodt, you will actively contribute to the clinical development from early to late stages. You will have opportunity to work with colleagues within clinical pharmacology group, as well as collaborating with team members across the organization. Mallinckrodt supports our employees in their career growth, fostering a healthy working environment, diversity and inclusion, as well as work-life balance.
Managing/reviewing bioanalytical analysis, conducting PK/PD analysis, and reporting.
Working with project team members to support any clinical pharmacology related issues from clinical operation to regulatory submission.
Participating clinical pharmacology program design to support regulatory submission, such as preparing clinical pharmacology sections in regulatory documents including IB, IND/NDA/sNDA package, and Briefing Books.
Working with preclinical colleagues to ensure sufficient preclinical PK/PD knowledge to support the first-in-man study, as well as clinical pharmacology program.
Participating project team meeting as the representative of clinical pharmacology line function.
Department specific/Non-essential responsibilities:
Participating in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
Participating and contributing to clinical pharmacology group discussions on principles of clinical pharmacology including clinical study design, analysis, and interpretation, as well as the application of these approaches to drug development from early to late stages.
PhD in pharmacology or related field, or Pharm D with a minimum of 1 year post graduation training.
Experience / Skills:
Minimum of 0-2 years' pharmaceutical industry experience required.
Excellent hands-on experience in using Phoenix WinNonlin or other software to conduct compartmental, and noncompartmental PK analysis.
Hands-on experience in conducting PK-PD modeling and simulation.
Proven ability to analyze data and interpret the data with the understanding of PK, transporter, DDI, and organ dysfunction.
Knowledge in population PK/PD modeling using NONMEM, R, or other software.
Excellent written and oral communication skills
Ability to organize and work simultaneously on multiple projects.
Ability to work in a matrix, project-oriented environment.
Independent, reliable and efficient
Interpersonal/influencing skills, and ability to work in a continually changing environment.