SK Life Science, Inc. · 2 months ago
Director, Clinical Pharmacology
Paramus, NJ
Full-time
Onsite
Director/Executive
7+ years expSK Life Science, Inc. is seeking a Director of Clinical Pharmacology to provide expertise in the design, execution, and reporting of clinical pharmacokinetic/pharmacodynamic studies. The role involves selecting Phase 1 CROs, mentoring staff, and contributing to regulatory filings and clinical study protocols.
BiotechnologyPharmaceutical
Responsibilities
Act as Clinical Pharmacology representative providing clinical pharmacology expertise to multidisciplinary study teams for one or more early and late-stage clinical and lifecycle management projects/programs
Provide support in the designing and interpreting of Phase 1 as well as other clinical studies/clinical programs that have PK or PK/PD data
Perform or supervise non-compartmental analysis of PK data and ensuring appropriate PK-PD analysis including population PK or PK/PD modeling and simulation analyses
Contribute to appropriate design of clinical study protocols and review of clinical study reports
Contribute to the selection of Phase 1 CROs
Participate in dose selection for Phase 1 as well as for Phase 2 and 3 clinical studies
Work closely with preclinical/nonclinical, biostatisticians, clinical operations colleagues, medical directors, and regulatory affairs personnel within SKLSI as well as in SKBP for the timely completion of clinical studies and regulatory filings
Represent the Clinical Pharmacology group on multi-disciplinary study/project teams
Responsible for and contribute CP related components to regulatory documents (INDs, NDAs, and IBs) as needed
Act as the Clinical Study Lead for all Clinical Pharmacology/Phase 1 studies
Qualification
Required
At least 7+ years of industry experience and a proven track record within the duties mentioned above with a background in PK and PD, Biopharmaceutics and Pharmacometrics
Previous experience in leading clinical pharmacology programs
Excellent writing and verbal communication skills
Ability to work in a matrix environment and with different leadership styles
Work independently, proactively and effectively
Preferred
PharmD or PhD degree in Pharmaceutical Sciences or related discipline will be considered
Experience in oncology preferred including a strong understanding of clinical trial design and regulatory requirements
Preferably a working knowledge of NONMEM and R or other commensurate software utilized in Pharmacometric analyses
Company
SK Life Science, Inc.
SK Life Science, Inc., a U.S. subsidiary of SK Biopharmaceuticals, stands at the forefront of innovation in healthcare.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Hong-Wook Kim
Vice President & Chief Operating Officer
Christine Mapes
CMO Manager, Supply Chain
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