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Clinical Feasibility Strategist & Optimizer

Main purpose

The Clinical Feasibility Strategist & Optimizerhelps to manage and coordinate the conduct of indication, protocol and site feasibility assessments. The Clinical Feasibility Strategist & Optimizer liaises with Program Teams/Study Teams to integrate demand, frame and solve problems, communicate analytics insights and support interpretation to shape implementation in specific business contexts - from program design to study planning. This especially requires to support the orchestration and interpretation of data-driven insights obtained from the internal team and specialized external vendors.

The position is supporting to drive continuous and integrative dialogue across the organization to identify stakeholder and customer needs and transparently share internal and external best practices / lessons learned across projects and portfolio to foster a continuous learning environment and standards across the organization (incl. Oncology, Radiology and Cell & Gene).

Scope

Global

Key tasks & Responsibilities

• Support cooperation with Program and Study Teams to identify and integrate demand for CTFA services into CTFA pipeline and support CTFA leadership in demand prioritization and portfolio management activities
• Help with the conduct of indication, protocol and site feasibility assessments; use internal and external analysis and data to identify alternate scenarios, derive strategic (e.g. cost, timelines) and operational (e.g. resource and start-up time) implications, and provide robust, data-driven recommendations to PTs/STs
• Closely collaborate with Insights Extractor/ Quality Controller, steering/coordinating activities by pointing out business needs, and supporting definition of analysis scope to ensure value creation in collaboration with internal analytics and vendors
• Support PTs/STs in interpretation of CTFA analysis and translating insights into options for Clinical Operations Roadmaps. Support Data/Solution Scout & Purchaser in evolving CTFA data/solution landscape by providing business needs. Support to critically evaluate and challenge external data and insights generated by vendor solutions​ in collaboration with the Insights Extractor/ Quality Controller, especially ensuring consistency across tools/ external vendors used along different services
• Support evolution of CTFA services by collecting and integrating customer feedback as well as by continuously reviewing, challenging, and improving ways of working, selection and use of external vendors, TA/ MoA-specific knowledge, and more
• Support improvement on CTFA process based on lessons learned from study execution

Key work relations internal/external (internal and external partners/customers)

• Head CTFA and team members
• IPT, GPT and CT members (e.g. GCL/ECL, PDL, CPM)
• Clinical Customer Experience Manager and other CCC team members
• CD&PE Heads and capability team members
• Related CD&PE and R&D functions, including platform companies
• External Customers (e.g. Thought Leaders, HCPs/investigators, networks, advocacy groups, medical/operational experts)
• External vendors/suppliers (e.g. business and competitive intelligence)

Qualifications & Competencies (education, skills, experiences, behavior, values)

The incumbent is a highly successful manager with extensive professional and academic experience. Key competencies needed by the candidate include the following:

• University degree (Bachelor) in science, business administration or an equivalent qualification with relevant work experiences
• 2-3+ years of experience in the pharmaceutical industry with focus on clinical development, either directly or from an intersecting function, like IT, Consulting, or CRO with specialization on clinical development
• Advanced understanding of the clinical drug development and commercialization process, regulatory requirements and guidelines (e.g., ICH, GCP, from protocol writing and study management to medical results reporting and submission)
• Knowledge and experience (min 3+ years) in clinical operations, feasibility assessment of clinical studies, protocol assessments, site identification, trial and site performance metrics including enrollment forecasting and modelling
• Basic experience of customer-engagement strategies and solutions in the clinical development area
• Strategic, problem solving and strong analytical skills with respect to complex clinical development data
• Ability to communicate effectively, fluent in written and spoken English and simplify complex and data-heavy topics
• Basic technical skills and specific experience in clinical intelligence tools and sources
• Good interpersonal skills to work in cross-functional and cross-cultural project teams
• Ability to self-organize, collaborate effectively without hierarchical authority and with accountability, pro-active and inclusive mindset, strong display of DSO behaviors

YOUR APPLICATION

This is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer. Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Location:

Spain : Cataluña : Barcelona

Division:

Pharmaceuticals

Reference Code:

864621