Job Summary:

The Director/Senior Director, Clinical Pharmacologist will contribute to the development and/or optimization of proprietary drug candidates by providing pharmacokinetic and toxicokinetic evaluation in non-clinical and clinical studies. This team member will provide oversight to relevant CROs and consultants in conjunction with the R&D leadership.

Duties/Responsibilities:

• Establishing pharmacokinetic testing strategies and analyzing pharmacokinetic-related data generated during clinical trials, providing summaries as requested.
• Thorough understanding of pharmacokinetic principles, including in-life aspects, modeling procedures (e.g., noncompartmental and compartmental), and interpretation of pharmacokinetic data
• Development and characterization of bioanalytical assay systems to be used in pharmacokinetic studies
• Identifying suitable CROs for PK studies, establishing good working relationships and installing contracts for respective studies
• Supervising monitoring of contracted pharmacokinetic studies as well as data interpretation
• Provides strategic and scientific advice regarding DMPK to Peer Review Committees and Senior Leadership
• Reporting of pharmacokinetic studies including integration of results in summary documents (e.g. IB, NDA and IMPD)
• Planning, monitoring and reporting of studies on time, on budget and by meeting highest scientific and regulatory quality standards
• Represent the PK/PD/ADME discipline on project teams
• Responsibility for PK assessments in toxicology and clinical studies and managing related activities at CROs including assay validation, sample analysis and reporting
• Contributing to Project Team activities by providing overviews, strategic planning and expert advice related to pharmacokinetic topics and tasks

Qualifications:

• PhD or advanced degree in Life Sciences (e.g. pharmacokinetics, drug metabolism, biochemistry, pharmaceutical sciences, or related)
• A minimum of 8+ year’s relevant experience in the field, with a minimum of 5 years industry experience. In-depth knowledge of pharmacokinetics, clinical pharmacology (including drug metabolism and PK/PD evaluation) and familiarity with standard ADME/PK modelling tools
• Significant experience designing, interpreting, and reporting nonclinical and clinical pharmacokinetic and PKPD modeling studies required to support regulatory submissions
• Experience in authoring regulatory documents with knowledge of global regulatory requirements and the relevant guidance documents
• Must have excellent writing and communication skills, attention to detail, and strong problem-solving skills, as well as the ability to work in a multidisciplinary team environment
• Experience in working in project teams
• Understanding of GXP compliance and ICH guidelines