OverviewThe Clinical Pharmacology (CP) Associate 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 will ensure that the preclinical characterization is adequate and provides support in characterizing the clinical pharmacology profile of a given compound; and 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. This individual may provide oversight and be responsible for the pharmacometric related analyses and activities in support of the CP profile of a compound and 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.
Responsibilities
- Act as CP representative providing CP 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 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, statisticians, clinical operations colleagues, medical directors, and regulatory affairs personnel and with other internal and external partners for the timely completion of clinical studies and regulatory filings
- Represent the CP 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
Qualifications
- PhD or PharmD degree in Pharmaceutical Sciences or related discipline
- At least 7 years of industry experience and a proven track record within the duties mentioned above with a background in PK and PD
- Previous experience in leading CP programs
- Highly skilled in compartmental/non-compartmental analyses
- Preferably a working knowledge of NONMEM and R
- Excellent writing and verbal communication skills
- Ability to work in a matrix environment and with different leadership styles
- Ability to work independently, proactively and effectively
- Ability to multitask
- Adapts to change
- Maintain composure under pressure
- Ability to follow verbal or written instructions and use of effective verbal communications
- Adapts change, adjust change and grasps information quickly
- Examine and observe details
