Position: Associate Director/Director Clinical Pharmacology, Drug Metabolism, and Pharmacokinetics
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity. Summary: At Forty Seven, the Associate Director/Director, Clinical Pharmacology functions as the Clinical Pharmacology/DMPK (CPD) team representative for biotherapeutic projects at various stages of research and development (target validation through life-cycle management) and is responsible for all aspects of pharmacokinetic/pharmacodynamics (PKPD) -related support for biotherapeutic products, including design of studies, analysis and reporting of data, and communication of data in regulatory documents and meetings. This position will report to the Senior Director, Clinical Pharmacology, Drug metabolism & Pharmacokinetics Essential Functions: • Provide clinical pharmacology expertise into clinical development plans, including the design, conduct and interpretation of relevant clinical pharmacology studies, analysis of data using advanced PKPD modelling and simulation methodologies, develop and help execute the regulatory strategy (e.g IB/IND, end of phase 1/2, and BLA), perform data analysis, and assist in reporting clinical studies. • Function as the sole point of contact for all CPD activities on projects at all stages of discovery and development and be able to influence team strategy using modelling expertise. • Be pivotally involved in the hands-on analysis and interpretation of clinical and nonclinical PK/PD data, integrating clinical trial simulation strategies and disseminating the relevant risk/benefit implications to the Company's project development teams. • Collaborate with biostatisticians, clinicians and clinical operation managers for the appropriate design of Phase I-III studies; contribute to the preparation of key documents including investigators brochures, clinical study protocols, study reports, and regulatory documents. • Drive clinical pharmacology strategy for projects at all stages of development - IND to BLA - and to defend these strategies at internal and external meetings. • Help design and conduct translational PK/PD modelling and simulation to support drug design goals, design of PK/PD and safety assessment studies, and dosing justifications for first-in-human clinical studies • Collaborate with toxicologists on the design, monitoring, and reporting of nonclinical safety studies; review and approve TK reports. • As a lean but growing department, contribute to the establishment of best practices for CPD activities – e.g. draft department SOPs, establish quality systems, create plan/report templates, etc. Education & Experience: • An advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated expertise in PKPD and clinical pharmacology and strong quantitative skills. • 8+ years of relevant industry experience required. • Proven track record of extensive experience in population modeling and simulations. Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is required. Familiarity with statistical software package Splus, R or SAS. • Knowledge of the use of modelling and simulation, and its role in discovery and development of therapeutics is required. • Strong publication and conference presentation track-record required. • Expertise in other modelling software (e.g. MATLAB, Berkeley-Madonna, etc) is highly desirable • Ability to communicate complex pharmacological concepts clearly and effectively to a wide range of staff members and colleagues, including those with technical and non-technical backgrounds, is required • Ability to function effectively in a highly matrixed environment, and to actively and effectively participate in cross-functional project teams is required. • Knowledge of biologics discovery and development - especially knowledge of bioanalytical strategy and GLP is desirable. • Knowledge of late stage regulatory experience – especially BLA filing desirable Other Information * Position may require occasional evening and/or weekend commitment * Position may require working with biological and/or chemical hazards * Position may require occasional travel (~15%), domestic and international. Location: Menlo Park, CA Position type: Full time
