Senior Director, Clinical Pharmacology

Responsibilities:

• Contributing to and implementing a comprehensive clinical pharmacology development strategy for our investigational compounds
• Designing and overseeing complex clinical pharmacology studies and/or assessments in healthy volunteers and in patients
• Serving as the departmental representative on project teams supporting nonclinical and clinical development
• Providing subject matter expertise in cross functional teams and collaborating with other team members
• Strictly adhering to agreed timelines to ensure prompt and accurate execution of deliverables
• Analyzing, interpreting, and reporting nonclinical and clinical data
• Plotting and evaluating animal and human pharmacokinetic data
• Reviewing and approving pharmacokinetic and/or toxicokinetic reports
• Reviewing and approving bioanalytical and method validation reports
• Understanding, establishing, and integrating innovative tools and technologies to accelerate drug development
• Authoring and owning the pharmacokinetic-related content of Investigator Brochures, study protocols, analysis plans, bioanalytical reports, and study reports
• Authoring, leading, and owning nonclinical and clinical pharmacokinetic-related documents for regulatory submissions, including INDs, NDAs, MAAs etc
• Supporting global regulatory interactions including preparing for and/or attending formal regulatory meetings, and responding to questions/requests from regulators
• Managing and mentoring direct and indirect reports
• Overseeing and managing vendors and consultants

Preferred Skills, Qualifications and Technical Proficiencies:

• Hands-on and in-depth knowledge of current versions of data analysis software such as Excel, GraphPad, WinNonlin, Monolix, NONMEM, R and/or other pharmacokinetic/pharmacometrics tools
• Hands-on and in-depth knowledge of current versions of PowerPoint and Word etc
• Thorough understanding of current regulatory requirements
• Excellent written and oral communication skills
• Proven ability to critically analyze problems, provide creative solutions, and influence senior leaders
• Discipline and confidence to work in teams and to work independently

Preferred Education and Experience:

• 10-15 or more years of industry experience and a PhD, PharmD or MD degree with emphasis in pharmacokinetics, clinical pharmacology, or a related field