Responsible for Preclinical and Clinical ADME (absorption, distribution, metabolism, excretion) and Pharmacokinetic results across all therapeutic areas. The Director is an integral member of the project teams, represents the department, provides subject matter expertise, and strategically leads the application of scientific and regulatory ADME, DDI, and Pharmacokinetic principles for the development of various drug products from preclinical candidate selection (pre-IND) through NDA filings and post-marketing commitments. This role is expected to provide their scientific and technical expertise to design ADME/Pharmacokinetic studies, which includes protocol development, monitoring of external study activities, data review, interpretation and quality control, finalization of reports, and communication of study results. This role will also author bioanalytical content related to drug assay in regulatory submissions and respond to regulatory questions on bioanalytical and ADME/Pharmacokinetic data and interpretation.

Primary Responsibilities

• Effectively representing the department in cross-functional teams to ensure the integration of modern pharmacokinetic principles in designing the toxicokinetic and clinical pharmacokinetic plans
• Perform pharmacokinetic non-compartmental and compartmental analyses and provide interpretation of the pharmacokinetic results for toxicokinetics and Phase 1 studies
• Bridging toxicokinetic findings and prediction of human pharmacokinetics by applying appropriate approaches, such as allometric scaling
• Provide pharmacokinetic input and work collaboratively with study biostatisticians, medical writers, clinical trial managers, and representatives from Regulatory Affairs, in support of the phase I and proof of concept trials
• Responsible for the preclinical and clinical pharmacokinetic-related section in documents, clinical protocols, study reports, investigator brochures, and regulatory documents
• Interacts effectively with members from various fields; serves as pharmacokinetic authority and liaises with partners on projects
• Ensures follow-up of studies and project timelines
• Facilitate establishment of contracts with CRO's selected to perform bioanalytical analyses and handle budget, agreements, and timelines
• Lead bioanalytical activities for studies across several programs and therapeutic areas
• Supervise assay development, validation, generation, and completion of assay performance reports
• Coordinate input into clinical study documents such as the protocol, lab manual, CRFs, and data and bioanalytical report deliverable timelines
• Act as a subject matter expert in bioanalytical compliance and regulatory audits
• Other duties as assigned

Education and Experience

• MD, PhD, or PharmD in pharmacokinetics, pharmaceutics, biopharmaceuticals, or a related field
• Targeting 10 years' experience in the Pharmaceutical Industry working in pharmacokinetics, bioanalysis, and drug metabolism
• An equivalent combination of related education and experience may be considered
• Demonstrated ability to successfully manage the drug metabolism, preclinical and clinical pharmacokinetic components of multiple drug products in early phases of development
• Demonstrated modern knowledge of international regulatory guidance pertaining to bioanalysis and ADME/Pharmacokinetics topics
• Demonstrated ability to successfully lead pharmacokinetic aspects of regulatory agency interactions
• Demonstrated ability to successfully interact with internal staff and manage external bioanalytical vendors
• Strong foundation in preclinical and clinical pharmacokinetics and a detailed understanding of non-clinical and clinical DMPK processes
• A sound working knowledge of regulatory documentation requirements
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Excellent interpersonal, communication, analytical, and organizational skills
• Ability to effectively present information to management, external contractors, and employees at all levels of the organization

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently, overnight, and after hours if required by travel schedule or business issues.