Clinical Central Services - Associate Director, Community Based

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Purpose
The Clinical Central Services & Innovation (CCSI) organization is responsible for strategically planning and providing trial support services, clinical trial supplies and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This organization enables innovative and foundational solutions including but not limited to central pharmacy services, mobile healthcare, telemedicine, virtual trial orchestration, recruitment & retention, community screening, new site models, and digital devices. Our mission is to increase clinical research awareness and diversity while reducing the patient and investigator burden in order to speed medicines to those in need. This group is within the broader Clinical Capabilities organization and partners across functions within Clinical Design, Delivery and Analytics (CDDA) and Product Research and Development (PRD) to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio.
The CCSI Associate Director is focused on the operations strategy and implementation for these capabilities. They will be responsible to drive the processes and partner with the clinical & design organizations to provide patient services like pharmacy and medical benefit coverage, direct-to-patient CT material delivery, and community-based research support. This role will also provide interpretation of decentralized trial regulations, clinical trial material regulations while working with global regulatory to align a consistent strategy across the portfolio. This role will also be responsible for vendor management and collaboration to drive implementation and coordinate efforts across the clinical capabilities' teams.
Primary Responsibilities This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Capability Development and Delivery

• Serve as Operational Lead, develop business strategies, processes, and technology as it relates to Clinical Central Services & innovation.
• Partner with study teams, external partners, and vendors to develop innovative solutions for the delivery of trial activities and services at alternative site locations (e.g., patient home, community health center or other HCP location).
• Partner with Clinical, Regulatory, Product Delivery, Quality, Procurement, Finance, BU's and other MDU functions to clearly understand the clinical trial requirements and patient needs to inform decisions around which capabilities best meet those requirements.
• Provide expertise of global regulations governing decentralized clinical research at Community Based health and alternative site locations including the distribution of pharmaceutical products and other trial supplies and develop a strategic plan to align with them.
• Continuously maintain a state of inspection readiness. Perform duties required for internal and external inspections as well as supporting institutions/investigators and alternative site locations in inspection readiness initiatives.
• Drive benchmarking, process improvement, shared learning, between teams.
• Develop critical success factors for pilot programs/projects and monitor progress to ensure clear criteria exists to enable decision making.

Project Management

• Understand business and financial acumen while minimizing the risk, delays, and potential interruption of clinical trial programs.
• Maintain operational alignment and prioritization for clinical services across functional and therapeutic areas.
• Provide guidance and consultation into forecasting and managing expenses.
• Identify project implementation risks and raise issues appropriately.
• Lead progress reporting activities and metrics.
• Manage Third Party Organization qualification process, selection, oversight.

Partnership

• Foster inclusion, innovation, and promote diversity.
• Partner closely within and across teams to effectively plan, forecast, and manage the portfolio and project work.
• Collaborate with vendors and other external partners to improve customer experience and monitor performance.
• Lead organizational change, communication planning and training initiatives.
• Identify, monitor, and communicate global customer (internal and external) needs/requirements related to process and/or technology performance and improvements.

Minimum Qualification Requirements

• Bachelor's degree
• 3 to 5 years of industry or health care related experience (regulatory affairs and/or project management, clinical drug development or a healthcare related field)

Other Information/Additional Preferences

• PharmD or other health care related degree preferred.
• Knowledge of drug development process.
• Strong networking, interpersonal and relationship skills with demonstrated ability to work in teams, across organizational boundaries and achieve results through others.
• Knowledge of emerging healthcare related services and capabilities for clinical research.
• Knowledge of country regulatory guidelines/requirements for clinical research conduct.
• Language Requirements: Must speak fluent English.

Additional Information/Requirements:

• Work outside of core hours may be required to support the portfolio across the globe.
• May require travel domestically and international (less than 10%)

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