Dir/Sr. Dir, CPMS (Modelling)Australia, Remote Job ID R0000005239 Category Medical Sciences
About this Role
Project and Program Management
• Analyze clinical PK/PD data as a member of several multidisciplinary development program teams.
• Work with clinical teams to design PK/PD components in various study designs such as first-in-human, Proof of Concept, Phase 2B, bioequivalence and drug-drug interaction studies.
• Author or contribute to clinical PK/PD sections of relevant documents.
• Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of development
• Review scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports
• Maintain a strong working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics
• Develop and maintain a relationship with internal and external clients and scientists
• Author clinical protocols, clinical study reports, regulatory responses and submissions and publications for peer review journals.
• Accountable for the strategic and operational delivery of client programs and projects to time lines, quality expectations and regulatory requirements.
• Drive embedding of LEAN concepts in process deployment and improvement
• Provide subject matter expertise to internal PAREXEL teams as needed
• Initiate and contribute to department and cross-BU improvement and training initiatives.
• Identify, quantify and as appropriate mitigate risks within the team driving business continuity and quality
Client Engagement and Business Development
• Initiate and maintain scientific and consultative relationships with clients contributing to strategy of client programs in CPMS
• Identify and follow through new business opportunities
• Think beyond function, business unit and geography to create new market opportunities
• Promote CPMS capability across Parexel to optimize integration in company and client initiatives.
• Oversee MSA price negotiations, e.g. rate cards and discount structures
• Accountable for the Customer Satisfaction
• Work with Marketing in the preparation and participation of webinars, symposiums, industry conferences, articles and white papers, etc.
• Review and lead preparation of Request for Information (RFI) and Request for Proposal (RFP) for potential clients
• Accountable for overall performance and delivery of direct reports to deliver on time and with first time quality, in alignment with Parexel values
• Manage team through clear and specific definition of accountabilities and expectations, assigning task/projects based on competencies and skills and helping staff to prioritize workload
• Recognize and reward colleague achievements
• Conduct formal review processes such as performance and salary reviews
• Lead and or participates in hiring process
• Responsible for group resourcing and effectively focus staff efforts on activities that are of high value
• Coach, mentor and train colleagues to help them meet organizational and personal career goals
• Create a culture of continuous improvement and lead team through change to deliver desired outcomes
• Excellent knowledge of PK and PD principles
• Strong experience with the design and implementation of Model-Based Drug Development strategies
• Expertise with Pharmacometric methodologies (e.g., disease modelling, conc-QT analysis, clinical trial simulation)
• Experience in Pharsight Software (WinNonlin/Phoenix)
• Experience in other software such as NONMEM, GastroPlus and R is desirable
• Significant experience in clinical drug development of both NCEs and biologicals
• Proven achievement in leading, managing and motivating teams
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• Significant competence in applying networking skills within Parexel and with external key opinion leaders and clients
• Proven record of developing and implementing strategies
• Uses expertise to influence change
• Demonstrated experience in identifying and adopting new technologies and techniques in support of an evolving business domain
• Ability to analyze business needs and act decisively
• Demonstrated experience and influence of strategy, design and implementation of projects and program deliverables
• Excellent problem solving, risk assessment and decision-making skills at the department and enterprise level
• Demonstrated emotional intelligence
Knowledge and Experience:
• Experience leading and managing successful teams
• Significant experience with application of clinical pharmacology, modeling and simulation in drug development and clinical trial conduct in pharmaceutical industry, CRO or academia desired
• Demonstrated expert knowledge of regulatory environment as it relates to CPMS and Drug Development