Clinical Pharmacology Modeling and Simulation, Associate Director

Key Function:

This role is an experienced scientist, increasingly responsible for the strategy and application of data management, programming, clinical pharmacology and modeling and simulation in client projects where CPMS services are used.The role is recognized for and provides scientific leadership in at least one discipline of CPMS working closely with the client to develop and implement strategies to support drug discovery and development programs.The role may lead client projects in one discipline of CPMS and is accountable for end to end delivery and quality review of all client projects under their leadership.S/he may provide guidance on development of new service lines and provide subject matter expertise to capability development projects within the department and across the integrated Parexel organization.The role serves as a key interface between the client and CPMS team and develops strong relationships with clients.

Job Description:

• 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, bioequivalence and drug-drug interaction studies.

• Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of PK/PD data management, programming, or modeling and simulation initiatives

• Review/author scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports; review and author scientific publications, abstracts, posters

• Review of derived PK/PD data generated by PK Analyst

• Develop and maintain a relationship with internal and external clients and scientists

• Begin to contribute strategically to design and implementation of client programs or projects (with guidance)

• Responsible for the operational delivery of multiple aspects of a client program or project to timelines, quality expectations and regulatory requirement.

• Responsible for quality of results in their areas of operational delivery

• Assist project leaders and/or line management in assessing project resource needs with respect to areas of responsibility

• Proactively recognize, analyze and take steps to mitigate increasingly complex problems that arise during conduct of business processes.

• Use initiative and innovation to remedy problems

• Provide subject matter expertise to internal Parexel teams as needed

• Effectively and independently implement business processes

• Understand LEAN concepts and applies them in day to day delivery of business processes.

• Contribute to the development of standard operating procedures relevant to CPMS

• Contribute to multiple department improvement and training initiatives.

• Provide support for client and regulatory audits

• Identify, develop and manage 3rd party relationships to support on-going delivery of CPMS capabilities

• Coach, mentor and train entry to intermediate level staff to help them meet organizational and personal career goals.

• Contribute to the preparation of marketing materials

• Contribute to the preparation of client proposals to include language

• May deliver sales and marketing presentations to potential clients

• Contribute to the development of training materials for internal Parexel use

• Develops key skills in "packaging" the business benefits of CPMS to Parexel customers.

Qualifications• Excellent knowledge of PK and PD principles

• Experience with the design and implementation of Model-Based Drug Development strategies

• Knowledge of Pharmacometric methodologies (e.g., conc-QT analysis, clinical trial simulation)

• Developing experience in leading projects and program deliverables

• Proficiency with desktop applications such as MS Office

• Capability of handling confidential matters and data

• Excellent interpersonal, verbal and written communication skills

• Collaborates effectively

• Demonstrates independent thought and ability to exercise judgment to influencing design and implementation of projects and program deliverables

• Excellent ability to balance operational and strategic priorities with proven time and project management skills

• Excellent attention to detail

• Clear and precise communication in English

• Experience in pharmaceutical industry, CRO or academia desired

• Experience in clinical drug development of both NCEs and biologicals

• Experience in other software such as NONMEM, SAS, R, Pharsight Software (PKS/WinNonlin/Phoenix) is desirable

• Experience working in UNIX/LINUX environment a plus. Experience with cloud computing a plus.

Education:

• Educated to PhD degree level preferred, relevant experience required