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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 standards.
• Continuously and efficiently manages stakeholders at various levels, across all US Medical functions.
• Addresses and resolves project challenges, keeping leadership informed of critical considerations (e.g., resources, performance concerns). Provides clarity and direction in urgent or unexpected situations.
• Provides clear and targeted messaging to teams, translating corporate priorities into clear and meaningful team goals
• Identifies ways to accelerate the project execution where possible while maintaining high quality standards.
• Manage the planning, operational and reporting logistics of the Research and/or other teams (including but not limited to: meeting schedule management, meeting facilitation, development of meeting materials with contributors, capture and follow up of action items and deliverables, distribution of minutes, and maintenance of relevant SharePoint site (or equivalent).
• Partners with the Head of US Medical Clinical Research to lead and manage Research Team meeting, or other teams, through the project plan execution and holds to the highest standards for operational excellence and compliance in all US Medical activities.
• Drive and deliver all aspects of clinical study execution from study concept to final reporting, coordinate and ensure team deliverables for project completion for assigned research activities across all functions.
• Responsible for building quality relationships with key cross functional stakeholders, that result in valued and trusted partnerships and program support.
• Proactively identifies potential issues or obstacles and achieves resolution or plans contingencies and follows issues through to resolution.
• Provides financial oversight for program/study budgets. Includes consolidation, vetting and prioritization of spending risks and opportunities, in partnership with Head of US Medical Clinical Research, and in collaboration with US MA Medical and Scientific Leads.
• Leads the project risk management process and generates the cross-functional project risk register for assigned projects. Ensure that the risks identified for US Medical activities are reported up through to the Program Manager and Medical and Scientific.
• Independently resolves complex issues and competing priorities that may impact achievement of goals, and creates mitigation plans and drives to resolution.
• Works closely with the US Medical Strategy Team/Medical Unit and/or other cross functional teams, to balance operational execution with Research strategy.
• Manages project status reporting and dashboards for a given program, including scheduled as well as ad-hoc updates.
• Participates in regular project portfolio reviews at the Medical Franchise Unit for a given TA to ensure accurate information, timelines and budgets are completed to support project recommendations to Senior Management.
• Generates collaboration, cooperation and communication across functions ensuring that team goals are achieved.
• Provides direction, mentors junior colleagues, as applicable, looks for opportunities for junior staff to demonstrate their abilities; uses effective coaching techniques; leads by example. May have responsibility for line management of Senior Managers, as well as contractors or CRO service providers.
• Orchestrates the involvement of appropriate cross-regional or cross-functional stakeholders in relevant communications, decisions and working group.
• Establish best practices and embrace an open, learning, sharing culture.
• Implement novel trial designs, including digital interventions, as applicable. DIMENSIONS AND ASPECTS
Technical/Functional Expertise
• Comprehensive understanding of the pharmaceutical industry and regulations governing medical functions within industry activities and medical regulatory process, including clinical research, study design, and good clinical practice.
• Strong clinical research and program management experienced in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function. Clinical Science experience a plus.
• Experience managing study budgets across multiple Therapeutic Areas
• Applied knowledge of performance management (e.g., metrics, dashboards) Decision-making and Autonomy
• Ability to predict issues, anticipate risks and solve problems
• Ability to articulate & establish processes to foster cross-functional efficiency or resource scalability Interaction
• Flexibility, tolerance and diplomacy to best manage change and differing opinions
• Ability to work in a highly complex, multi-cultural, often stressful environment
• Highly effective communications skills - written and verbal
• Demonstrated ability to concisely communicate/prepare presentations for management
• Excellent organizational skills
• Effective negotiation and positive influencing abilities
• Proven ability to work effectively and diplomatically in conflict situations Innovation
• Experience in identifying and driving opportunities for process improvements with significant organizational impact and takes on, as needed, non-project responsibilities, which can include project management to implement new processes and systems Complexity
Management of multiple tasks of varied complexity to enable successful delivery of multiple and/or complex projects within a single or across therapeutic areas for US Medical
EDUCATION . click apply for full job details
Date Posted: 04 May 2025
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