Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Program Management Expertise
• Oversees customer-driven design and development activities through leadership and coordination of cross-functional IQVIA and Sponsor delivery teams.
• Manages Design Teams to deliver activities such as Clinical Development plans, program and protocol designs, clinical-commercial planning
• Ensures continuity and linkage of all design activities through to operational planning and execution
• If required by the Sponsor, follows an asset through its contracted asset life-cycle and engage in cross-functional coordination activities between IQVIA and the Sponsor as required to achieve delivery of the Integrated Asset Development Plan or other specified deliverables.
• Participates in all team, Steering Committee, and Advisory Boards as appropriate to achieve the contracted Integrated Asset Development Plan or other specified deliverables.
• Collaborates in the design and subsequent management of a virtual resource network to support product development team activities.
• Maintains a working knowledge of the IQVIA policies, processes and procedures and a working knowledge of IT systems and capabilities tools (in particular, Infosario Design and Infosario Clinical) to be able to serve as an informed advisor/coordinator.
• Participates in proposal and budget development and sales/proposal presentations, as required including evaluation of the feasibility of delivering potential programs
• Serves as a program management liaison with other groups within IQVIA.
Drug Development Subject Matter Expertise (with a particular focus program management & operational scenario planning)
• Provides pharmaceutical/device program management and development operations (time, cost, risk trade-off) subject matter expertise to enhance drug development planning insight.
o Input into an Integrated Asset Development Plan that is aligned with a Target Product Profile (or similar): Ensures integration of any detailed "sub plans" for each functional area. e.g. Clinical Development Plan, Regulatory Strategy, Biostatistics Analysis Strategies, Commercial Strategic Plans, Clinical Operational Plans, CMC Plans, etc.
o Input into structured planning and design processes that result in optimized Clinical programs and protocols that are based on sound scientific rationale and supported by robust data and feasibility assessments (scientific, commercial and operational).
o Building robust cost-time-risk trade-off scenarios that enable sound clinical program decision-making
• Supports asset and portfolio management, including due diligence activities, as appropriate
o Support of governance structures, stakeholder analysis and decision-making processes as required to support Portfolio/ Candidate Drug/Device oversight
o Asset development planning (for active Asset Management activities, see below)
o Due Diligence activities
o Target Product Profile or Disease Area Profile development (including financial and "probability of technical success" assessments)
Asset Management (as appropriate)
o Establishes operational strategy to ensure successful delivery against program/development objectives.
o Develops and manages program level budget.
o Establishes and implements Change Control processes to control project scope and schedules.
o Ensures effective Communication strategies are established including maintenance of program management systems (dashboards, visualizations, etc.)
o Develops Risk Management strategies and ensures ongoing risk assessment/ contingency planning is performed thereby optimizing success of program objectives.
o Develops Quality Management Strategies (based on "Quality by Design" approaches)
o Establishes Resource Management Strategies to ensure resources are available to meet project deliverables and milestones.
o Ensures smooth transitions between all design activities into Operational Delivery (including Reporting)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's degree in life sciences, advanced degree preferred, with specialization in one or more therapeutic areas and 15 years global clinical research relevant experience, including hands on operational delivery and/or drug development experience; or equivalent combination of education, training and experience
• Proven track record in operational delivery and/or drug development
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
QVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at email@example.com to arrange for such an accommodation.
Job ID: R1066688