Drug Development Leader: Home or Office-based
***This is a Home or Office-based position. Candidates can be from anywhere in the US and/or the EU.
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The Drug Development Lead (DDL) manages cross-functional teams (IQVIA/Sponsor) working on customer-driven design and development activities. The DDL manages the scope of work, objectives, timelines, quality of deliverables, and all other program management activities to ensure high-quality delivery of a design or development program, and contributes input to these activities based on their drug development expertise.
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 and provide scientific input to deliver data driven deliverables such as Clinical Development plans, due diligence evaluations, program and protocol designs, clinical-commercial planning.
Ensures smooth transitions between all design activities into Operational Delivery.
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 (Pipeline Architect) 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.
Develops and manages program level budget.
Establishes and implements Change Control processes to control project scope and schedules.
Drug Development Subject Matter Expertise (with a focus program management & operational scenario planning).
Provide pharmaceutical/device program management and development operations (time, cost, risk trade-off) subject matter expertise to enhance drug development planning insight.
Lead and provide input into Integrated Asset Development Plans: Ensure 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.
Lead and provide 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).
Supports asset and portfolio management, including due diligence activities, as appropriate. Activities include: Support of governance structures; Technical Due Diligence activities; and Target Product Profile or Disease Area Profile development.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In-depth regulatory, clinical, scientific, technical and/or therapeutic expertise.
Strong knowledge of drug development.
Strong project leadership capabilities.
Knowledge of program management procedures and systems and skill in applying them creatively in a resource constrained environment.
Excellent communication and interpersonal skills, including good command of English language.
Proven ability to work through others to deliver results to the appropriate performance metrics.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to balance operational and strategic priorities.
Proficiency with software applications including Microsoft PowerPoint, Excel, Word, Project, Outlook, Teams, and Visio.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
A minimum of a Master’s degree in life sciences or related field; advanced degree (MS, MD, PhD., Pharm. D.) desirable.
Minimum of 10 years industry experience including a minimum of 3 years in a program management role (or equivalent experience).
Direct experience with leading drug development teams in a matrix environment.
Experience in a drug development functional role within the biopharmaceutical / device or CRO industry (e.g., Clinical Operations, Pre-clinical Development; Clinical Development, CMC, PK/PD, Regulatory Affairs, Program Management).
Global-working/international experience in culturally diverse environments.
Experience managing cross-functional teams / programs.
Typically requires up to 30% travel.
Senior level role may have direct reports and require appropriate managerial skills
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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
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.
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