We have an exciting opportunity for an Associate Director,Director Pharmacokinetics, Immunology Therapeutic Area based in North Chicago, IL
Key Responsibilities:
•Provides expert Clinical Pharmacokinetic (PK)/Pharmacodynamic (PD)/Clinical Pharmacology strategic input to R&D, Regualtory Affairs, Medical Affairs, and all levels of CPPM management on critical decisions
•Responsible project reviews and for critically evaluating technical and scientific aspects of Clinical PK/PD projects/programs with CPPM Management
•Conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve Clinical Pharmacology goals and regulatory requirements for multiple functions
•Independently conducts scientific due diligence on compounds
•Anticipates and critically evaluates Clinical Pharmacology and/or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies
•Responsible for leading Clinical Pharmacology/PK/PD aspects
•Serves as Clinical PK/PD liaison to other departments for studies and multiple projects
•Manages of one or more Clinical Pharmacology programs
•Independently leads PK/PD activities and multiple major projects across multiple projects
•Provides critical interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submission
•Is the primary author in high-impact factor peer-reviewed journals, R&D reports, and/or regulatory documents/filings
•Analyzes the impact of PK/PD decisions across multiple projects
•Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact) and competitive information
•Develops productive collaborations and communications with other groups across multiple disciplines
Qualifications
Director, Clinical Pharmacokinetics
PhD in related field
Typically 8 yrs experience in the pharmaceutical industry or equivalent,
Substantial understanding in multiple therapeutic areas or disease state/indications
Knowledge and understanding in application of R&D business procedures and of clinical trial methodology, applicable regulatory guidances, global regulations, ethical issues associated with clinical studies, SOPs
Proven track record of successful projects (report/submissions delivered on time, high quality) in a cross functional team environment
Participated in and is key contributor to initiatives and advancement of CPPM and R&D or equivalent
Advanced knowledge of and experience in multiple therapeutic and/or functional areas.
Experience across range of development phases
Must have demonstrated experience in managing and completing multiple complex projects within CPPM or equivalent experience
Must have demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple complex projects and one or more TAs
Key Leadership Competencies:
•Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
•Learns fast, grasps the 'essence' and can change the course quickly where indicated
•Raises the bar and is never satisfied with the status quo
•Creates a learning environment, open to suggestions and experimentation for improvement
•Embraces the ideas of others, nurtures innovation and manages innovation to reality
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