Director, Clinical Pharmacology

The Clinical Pharmacology (CP), Director role will effectively provide expertise and support for the design, execution, interpretation and reporting of clinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This individual will participate in the selection of Phase 1 CROs for clinical pharmacology studies. Individual will be functional CP Lead and will ensure that the preclinical characterization is adequate and provides support in characterizing the clinical pharmacology profile of a given compound.  CP Lead will also ensure that the CP strategy/plans fully support the selection of dose(s) and regimen for Phase 1, 2 and 3 studies. Individual will serve as CP representative on studies and project teams, and will contribute to the planning, writing, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams and external collaborators. The Clinical Pharmacology, Director may provide oversight and be responsible for the pharmacometric related analyses and activities in support of the clinical pharmacology profile of a compound.  The Director may also serve as a mentor to less experienced staff and as a Clinical Pharmacology resource within the function and across the company (eg. in matters related to due diligence).

• 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

• PharmD and/or PhD degree in Pharmaceutical Sciences or related discipline will be considered
• At least 7+ years of industry experience and a proven track record within the duties mentioned above with a background in PK, PD, Biopharmaceutics, and Pharmacometrics
• Previous experience in leading clinical pharmacology programs. Experience in oncology preferred including a strong understanding of clinical trial design and regulatory requirements
• Preferably a working knowledge of NONMEM, R or other commensurate software utilized in Pharmacometric analyses
• Excellent writing and verbal communication skills
• Ability to work in a matrix environment and with different leadership styles
• Work independently, proactively and effectively