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Associate Director Pharmacokinetics

Associate Director Pharmacokinetics
Company:

Iqvia - Australia


Details of the offer

A new opportunity within the Australian Biotech Delivery Unit in our Pharmacokinetic team. We provide planning, modelling and analytical support to our biotech customers and this role will be to establish and manage a local team of clinical pharmacology scientists along with working closely with customers to meet their needs. To succeed in this position, candidates must have excellent verbal and written communication skills, highly effective organizational and leadership skills, strong coaching and mentoring skills and the ability to problem solve and think analytically at a high level. You will also have the ability to interact in a cross-functional and multi-cultural environment and establish effective working relationships with direct reports, coworkers, managers, vendors and clients*Responsibilities include:** Design studies, develop or oversee the development of clinical development plans, protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, listings, and figures, and clinical study reports for Phase I-II clinical pharmacology and population PK studies Prepare PK/PD sections of global dossiers for product registration and communicate with regulatory agencies worldwide.* Manage allocation of PK/PD resources, including project assignment and capacity management.* Provide direction, support, and policy development recommendations to Clinical Pharmacology PK/PD staff and the Clinical Pharmacology management team.* Ensure quality, timely, and uniform delivery of Clinical Pharmacology PK/PD deliverables to Quintiles clients.* Recommend and implement quality control (QC) assessment and procedures, as well as scientific review.* Participate in proposal and budget development for Clinical Pharmacology PK/PD components of business proposals.* Provide technical training and mentoring to Clinical Pharmacology PK/PD scientists and other Clinical Pharmacology staff.* May serve as Clinical Pharmacology representative on company-wide task forces, when required.* Participate with management in marketing Clinical Pharmacology PK/PD services, including support for the development of new client and project opportunities.* Participate in the departmental budgeting process and participate in development and harmonization of SOPs and department procedures.* Serve as departmental liaison to other Clinical Pharmacology divisions to promote cross-functional integration and harmonization.* Maintain awareness of overall developments in the field of Clinical Pharmacology and PK/PD based on current literature, application of new technology, attendance at professional meetings, etc., and ensure that direct reports remain current on PK/PD developments.* Maintain close contact with the Business Development and Project Planning Managers and contribute to the formation of the early project team and initial project work.* Perform other duties as assigned by Clinical Pharmacology Management.* Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.Skills and experience required:* Ph D. in Pharmacokinetics / Pharmaceuticals and/or Master's degree in PharmD in Pharmacy or related field with 7 - 9 years industry experience including Clinical Pharmacology and Line Management experience* Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling as required, current therapeutic environment and drug development trends,* Sound knowledge of appropriate PK/PD standards and processes* Good understanding of the principles of the drug development process, ICH GCP, and applicable international and national regulatory requirements* Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, and SigmaPlot graphics, as well as NONMEM, SPlus and basic SAS programming, as required* Ability to work within a matrix team environment* Ability to prioritize, and independently coordinate and manage PK/PD component of complex projectsFor further information regarding this or any other vacancies we have at IQVIA please contact the Talent Acquisition Team on 02 9016 8100 / ***** At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .


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Associate Director Pharmacokinetics
Company:

Iqvia - Australia


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