Associate Director, Clinical Pharmacology & Pharmacometrics - Pasadena - ref. w52059115

Job Duties:

• Integrates pharmacokinetic and pharmacology expertise to support preclinical and clinical activities for programs including T-cell engaging bispecifics, dual checkpoint inhibitors and anti-cytokines
• Supports pre-IND activities including FIH dose selection
• Collaborates cross-functionally with Research/Biometric/Bioinformatics/Clinical/ Translational team to analyze and integrate PKPD and activity readouts to inform dose optimization, dose-escalation/expansion and RP2D decisions
• Leads the execution of clinical pharmacology studies
• Authors and reviews documents including clinical protocols, and regulatory submissions such as briefing documents, INDs, IB, clinical study reports, CTAs and NDAs
• Manages functional contractors to support additional workload as needed
• Maintains current knowledge of the field and area(s) of scientific and technical expertise and development

Education/Experience/Skills:

• Position requires a Masters degree in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Applied Mathematics, or a related discipline, plus a minimum of 5 years of related experience; a PhD with 5 years of related experience is preferred.
• Experience managing external service providers and CROs with timely delivery of clear, accurate and well-written study findings also required.
• Strong immunology knowledge and experience and prior experience with T cell engagers or anti-cytokine therapies is preferred.
• Proficiency with hands-on data analysis, modelling, and reporting using Phoenix WinNonLin, MATLAB, Rstudio, NonMem, or equivalent
• Strong knowledge and user competency in additional common software and data analysis packages (e.g., Microsoft Office Suite, SoftMax Pro, GraphPad Prism, JMP)
• Strong knowledge of drug development and FDA and ICH guidance documents
• Excellent communication skills, including technical writing and verbal communications for productive cross-functional team interactions.
• Occasional travel may be required, including travel between our offices. Work for this position is generally performed at the worksite and requires full-time commitment.