Dir/Sr. Dir, CPMS (Modelling)

Key Accountabilities:

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

People Management

 • 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

Skills:

• 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