450 projects straddling discovery through development in PK Sciences (PKS) for you to represent the PK/PD/ADME discipline on discovery and development project teams. As a project team member, you will also suggest and implement strategies and tactics to advance high-quality entities as part of the overall program(s).
PK Sciences (PKS) is a global organization of about 300 associates, situated within Translational Medicine (TM), the clinical research arm of NIBR. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application. PK Science is an enterprise organization, working across both NIBR and the Global Drug Development (GDD) organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology.
In the role of Director, PKS Oncology you will develop and implement clinical pharmacology strategies to support small and large molecule drug development from early discovery through late clinical development. This unique role will provide matrix leadership to collaborate, align and influence across the cross-functional team to identify and mitigate key project issues related to the pharmacokinetic sciences [PKS] discipline (PK, PK/PD, metabolism and clinical pharmacology).
You will be expected to proactively contribute to develop candidate drug products from early discovery through late clinical development providing expert pharmacokinetic / drug metabolism and clinical pharmacology input.
In addition, you will be responsible for the PK, PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND / IMPDs and NDA/BLAs within agreed timelines and which meet regulatory requirements as well as prepare appropriate responses to Health Authority questions (globally). You will have the opportunity to oversee or perform PK and PK/PD analyses using a variety of tools and approaches and integrate, interpret and report data to project teams and other customers.
• Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related biologic back ground. • A minimum of 10 years in a drug development function including 5 plus years experience in a lead role overseeing clinical pharmacology strategy of compound development. • Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation, experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences. • Hands-on project experience with low molecular weight as well as biologics modalities; experience in cell-based and/or gene-based therapies desirable. • Proven record as leader with good negotiation, organizational and project management skills. • Strong coaching, mentoring or people management skills are desired. • Ability to evaluate in-licensing opportunities and carry out Due Diligence activities as required.
Position will be filled at level commensurate with experience
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