Associate Director, Strategic Planning and Feasibility Lead

Main responsibilities:

• Accountable and responsible for developing trial level feasibility and strategic allocation plans, aligned with global indication/program feasibility and allocation strategy, within assigned Development Unit(s), and according to portfolio prioritization.

• Leads multidisciplinary Trial Feasibility Team with GCTs and/or CTTs, Regions and COs to develop validate and refine allocation strategy, including timelines and scenarios and risk mitigation plans. Identifies and resolves events in the indication landscape that represent operational risks for the execution of clinical trials within the given indication/program. Leads integration of regional and local indication strategies within global execution plans.

• Key contributor to feasibility strategy within assigned trial(s); provide global feasibility input into protocol development and/or trial design, based on health insights and feasibility assessment from Global Health Insight Directors, Regions and/or Countries. Ensures feedback from feasibility assessment is addressed.

• Leads analyses of clinical intelligence data describing the indication landscape, including scientific and epidemiology data, competitive intelligence, treatment paradigms and potential site partners globally, from external and internal research data sources, based on the clinical intelligence package received from Health Insights Manager.

• Develops risk management strategies for clinical trial(s) highlighting feasibility-related operational risks and mitigation actions for program and trial feasibility and allocation.

• Leads development of innovative solutions in trial allocation strategic plans to ensure adequate patient accessibility, patient engagement, and alignment with regional and country strategies.

• Performs ongoing analysis and reassessment of feasibility against recruitment throughout the lifecycle of the trial, including re-allocation or corrective actions when needed.

• Ensures alignment of feasibility and allocation strategy and seamless start up planning with Global Feasibility Director, in collaboration with teams/associates responsible for regional feasibility.

• Partnering with Global Health Insights Director(s), builds center of excellence in strategic feasibility and allocation planning by developing process standards and tools to achieve strategic feasibility and allocation excellence in GDO.

• Drives multidisciplinary taskforces and supports implementation of initiatives to optimize best practices for strategic feasibility to support continuous improvement and other management initiatives.

• Key contributor and lead for Global Feasibility Management forums, initiatives, or working groups. Serves as faculty member for franchise training programs.

Ideal background

• Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred.

• Fluent English (oral and written)

• At least 5 years of pharmaceutical clinical drug development experience recommended (with ≥3 years in planning/execution global clinical trials recommended)

• Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study.

• Possess strong, resourceful research skills to locate unusual information and have capacity to develop a deep domain specific knowledge base.

• Understand the Clinical Trial matrixed process from research through post marketing phase IV, health authority guidelines, country challenges as well as sources for therapeutic area data.

• Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but able to coordinate the activities of others. 

• Demonstrated experience in feasibility for global clinical trials.

• Demonstrated ability to navigate in matrix environment.

• Has experience in or understanding of trial level budgeting.

• Has coached, mentored, on boarded peers and/or new associates.

• Has had success in identifying, proactively flagging, and resolving risks; experience with strategic scenario planning and management.

• Excellent negotiation and conflict resolution skills. 

• Excellent organizational, interpersonal skills with extensive networking expected. 

• Communicates effectively with leaders in a local/regional/global matrixed environment.

• Proven ability on strategic planning and managing operational challenges at global, regional or country level.

• Good project management capabilities with demonstrated ability to problem solve and mediate complex issues. 

• Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authority regulations, and clinical development process.  

• Good understanding of global competitive landscape and implications on clinical development.

• Good medical/scientific understanding; ability to translate to business knowledge and trial execution.

• Good understanding of pharmaceutical industry, key competitors in disease area, commercial strategy integration into clinical trials.

• Strong leadership and negotiation skills.

• Demonstrated strong presentation and diplomacy skills.

• Demonstrated ability to influence without direct authority.

• Location: EMEA & USA

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