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 Associate Director/Director, PKS Oncology you will provide ADME/DMPK project support/representation for a portion the small molecule portfolio in Oncology from Discovery through IND filing. In this unique role you will collaborate with partner PK Sciences functions including in vitro and in vivo ADME, biotransformation and bioanalytics and will represent the PK Sciences organization within project teams.
Your main accountabilities will be to:
- Support teams in developing the strategy for, and coordinate the implementation of, the characterization and selection of lead compounds and drug candidates with favorable PK/ADME properties, elucidate PK/PD relationships driving efficacy/safety and contribute to human PK prediction and dose and regimen selection.
- Provide matrixed leadership across the organization to 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).
- Proactively contribute to develop candidate drug products from early discovery and beyond, providing expert pharmacokinetic / drug metabolism and clinical pharmacology input.
- 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 within agreed timelines and which meet regulatory requirements as well as prepare appropriate responses to Health Authority questions (globally).
- 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. Our organization further offers the opportunity to seamlessly gain exposure to different stages of development, different drug modalities and cross-train in multiple indications.
What you will bring to the role:
• Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related biologic back ground.
• A minimum of 5-10 years in a drug discovery/early development function including 2-5 plus years of experience in a lead role overseeing ADME/DMPK 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 drug discovery and development.
• 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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