Sr. Therapeutic Stategy Director - (R1026995) in Research Triangle Park, NC at IQVIA™

Date Posted: 7/28/2018

Job Snapshot

Job Description

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.

Description

PURPOSE
 
Reporting to a VP of Strategic Drug Development, 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.
 
RESPONSIBILITIES
 
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 provides scientific input to deliver data driven deliverables such as clinical development plans, due diligence evaluations, program and protocol designs, and 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 (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.
Drug Development Subject Matter Expertise (with a 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.
 
Examples include:
 
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    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).
 
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
 
Examples include:
 
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    Standalone technical Due Diligence activities and coordination for integrated commercial and technical due diligence
 
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)

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
 
• In-depth 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
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• 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
• Good team leadership skills
• Strong influencing and negotiation skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Ability to balance operational and strategic priorities
• Excellent customer service skills
• Good judgment and decision-making skills
• Good understanding of other IQVIA functions and their inter- relationship with Innovation Portfolio / Candidate Management
• Strong software and computer skills, including MS Office applications
• Senior level role may have direct reports and require appropriate managerial skills
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
 
•         A minimum of a bachelor'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);
•         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
 
PHYSICAL REQUIREMENTS          
.
•         Extensive use of keyboard requiring repetitive motion of fingers.
•         Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
•         Regular sitting for extended periods of time.
•         Typically requires 30% travel.
EEO Minorities/Females/Protected Veterans/Disabled

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™.


Job ID: R1026995