Associate Director, Clinical Research, Value & Evidence Generation, US Medical

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Job Description

Associate Director, Clinical Research, Value & Evidence Generation, US Medical

Lexington, MA

Hybrid

OBJECTIVES/PURPOSE:

Provides clinical project management and leadership to ensure successful operational execution of all US Medical Clinical Research including, Medical Affairs Company Sponsored Studies (MACS) collaborative studies and Investigator Initiated Research (IIR). Specific objectives include:

• Partners with Head of US Medical Clinical Science Lead to translate strategy into efficiently executable research plan; predicting and planning solutions to achieve successful operational execution to meet study objectives and strategic objectives; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies to get back on plan and navigating through the internal governance for projects.
• Responsible for the design and conduct of MACS, collaborative studies and IIR within assigned TA in accordance with all applicable internal legal and compliance policies as well as external US-specific regulatory guidelines.
• Partners with US Medical TA leadership to determine project prioritization according to TA medical strategy. Proposes resource needs according to study complexity. Leads operational planning activities; reports on program progress; manage individual study budgets and communicates status to appropriate TA project manager; and execute communication and change management plans.
• Represents and supports US Medical Clinical Research including synopsis and protocol development with all relevant stakeholders. Oversee reporting of study and/or program progress; ensure appropriate invoicing/budget management. Represents US Medical externally with external collaborators and investigators to develop and ensure execution of research plans, as applicable.  
• Identifies and drives innovative process improvements with significant organizational impact and takes on, as needed, non-project responsibilities, which can include project management processes and systems.
• Lead and matrix-manage high performing study teams, collaborating across the organization.

ACCOUNTABILITIES

Research Study Delivery

• Defines annual IIR key objectives and KPI’s in partnership with Clinical Science Lead and TA Medical Teams,as applicable.
• Provides ongoing reporting on individual studies program progress to inform budget management/invoicing, publications planning, and general progress on TA medical strategy(ies).
• Ensures that regular reporting (e.g., key product dashboards, financial aspects) are delivered with high quality and partner with TA Project Managers as necessary.
• Oversees & manages external CRO partners accountable to support operational execution of IIR work.

MACS and Externally Sponsored Research

• Defines annual Research key objectives and KPI’s in partnership with Clinical Science Lead and TA Medical Teams.
• Drive and deliver all aspects of clinical trial execution from study concept to final reporting

Research and Strategic Implementation Excellence

• Identifies scalable and consistent reporting methods to transparently inform on key TA or medical products.
• Provides direction and obtains buy-in from relevant internal stakeholders and team members to therapeutic, functional, or operational strategy.
• Identifies ways to accelerate the project execution where possible while maintaining high quality