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Senior Clinical Program Leader
Job Opportunity at
Clinical Dynamix, Inc.
Posted on Aug 4
Job Category: Research & Development
The Senior Clinical Program Leader I3 (Inflammation, Immunology and/or Infectious Disease) is accountable for the operational strategy, planning and execution of the clinical development portfolio up to LIP for the designated Discovery and Translational Area (DTA).
You provide the primary interface between the I3 DTA and pRED’s the Clinical Program Execution (CPEX) function in Clinical Operations, oversight for program and study management, line management of key operational roles. -
As a member of the I3 DTA Portfolio Committee (DTA-PC) and the Development Review Committee (DRC), you are empowered to make key operational strategic decisions and provide technical review on behalf of clinical operations.
As member of these committees, you provide direction and therapeutic area operational expertise and ensures effective implementation.
You are accountable for delivery of programs with respect to quality, timelines, budget and ensures resources from the sub-functions of CPEX are available to the DTA. The SCPL, I3 defines the clinical operations sourcing strategy for their designated DTA and is accountable for the placement of programs.
You will have a good working relationship with internal and external stakeholders and have oversight of the management of Key Accounts with investigators and academic centers.
You will contribute toward the design of pRED CDPs and clinical protocols to enable flexible and innovative development of operational strategies with appropriate scenario planning, which include forecasting of timelines, resources and budget, as well as program level feasibility assessment.
You will have responsibility as line manager of CPLs, SL Team Leaders and Documentation Specialist for the designated therapeutic area: - leading assessments/evaluations on topics that relate to study management and study leadership - talent management and development of Study Leader group, change management, communication for leadership teams.
You have significant post-graduate experience in clinical drug development and preferably Clinical Operations experience after having obtained a Life Sciences degree and higher qualification. In addition, you are/have:
Expert understanding, knowledge and experience of drug development across the value chain with particular focus on early development and clinical pharmacology.
Experience in Inflammation, Immunology and/or Infectious Disease
Experience in the management of a Global Clinical Operations Department, as it relates to systems/processes, staff recruitment, resource management, and talent management is highly desired.
Proven experience in strategic planning across phases. Ability to anticipate and solve problems, strong analytical skills, including previous experience with forecasting and analyzing benchmarking research results.
Proven ability to understand and critically assess global clinical development plans, protocol design, resources needs, global budgets and timelines for multiple programs across multiple DA
Significant direct line management experience as well as demonstrated leadership, influencing, communication and strategic project management skills.
Demonstrated pragmatism and willingness to drive and support change
Demonstrated ability to challenge established practices and concepts
Creates new and novel concepts to resolve complex challenges
Proven ability to support innovation even if taken outside of his/her comfort zone
Highly effective verbal and written communication skills in English, any other language skills may be an asset
Stong Line Management/People Management experience required
Therapeutic area: Inflammation, infectious disease and Immunology
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