BioSpace
Associate Director, Global Feasibility Lead
BioSpace, King Of Prussia, Pennsylvania, United States, 19406
Overview
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Associate Director, Global Feasibility Lead
is responsible for leading the strategic planning and execution of global feasibility assessments across clinical development programs. This role ensures that feasibility activities are data-driven, regionally informed, and aligned with the broader clinical and operational strategy. Operating within a matrixed and cross-functional environment, the Associate Director partners with therapeutic area leads, clinical operations, and external service providers to deliver robust feasibility insights that inform country and site selection, enrollment forecasting, and risk mitigation strategies. The role also oversees the development and deployment of feasibility tools, manages feasibility data integrity, and ensures timely delivery of feasibility outputs to support protocol finalization and study startup. This position plays a critical role in early engagement with investigators and sites, shaping the feasibility narrative and contributing to the operational design of clinical trials. The Associate Director is expected to proactively identify feasibility risks, propose mitigation strategies, and escalate issues as needed to ensure successful trial execution. Responsibilities
Feasibility Strategy Development: Lead the design and implementation of global feasibility strategies to support protocol optimization and country/site selection. Cross-Functional Collaboration: Partner with clinical operations, therapeutic area leads, and external vendors to gather input and align feasibility outputs with study needs. Data Analysis & Forecasting: Analyze historical data, epidemiology, and site performance metrics to generate enrollment forecasts and identify potential risks. Feasibility Tool Management: Oversee the development and deployment of feasibility tools and templates to ensure consistency and quality across programs. Stakeholder Engagement: Facilitate early engagement with investigators and sites to validate feasibility assumptions and support study startup planning. Act as the primary point of contact both internally and externally for study-related matters (e.g., vendors). Maintain up-to-date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations. Support audits/inspections and resolution of findings. Support development of new SOPs, guidelines, and participation in working groups on new processes. Functional leadership and mentorship of junior staff; advise other ClinOps colleagues within and across therapeutic areas. Provide oversight and direction for assigned studies/programs, ensuring appropriate delegation, inter-program efficiencies, and applied learnings. Job Qualifications And Experience
Education At minimum, bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related area preferred. Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist). Experience Minimum of 10 years’ relevant clinical research (or related) experience within the pharmaceutical industry. Solid understanding of the drug development process and each step within the clinical trial process. Experience in running feasibility activities for large and/or complex global clinical trials. Robust budget forecasting and management experience. Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process. Competencies Demonstrated ability to lead teams and work in a fast-paced team environment. Experience in working within a matrix environment and resolving interpersonal conflicts. Ability to mentor and coach others through peer-to-peer interactions and develop personnel in complex clinical project management. Ability to evaluate, judge, and make decisions regarding staff; able to teach/coaching and model best practices. Excellent interpersonal and decision-making skills. Demonstrates innovation, drive, energy, and enthusiasm to deliver program objectives. Skilled at independently navigating new indications, study/program approaches, and unique challenges. Strong understanding of all tasks involved in a clinical development program from protocol development to final clinical study report. Ability to plan, execute, and complete clinical programs to high ethical and scientific standards. Extensive knowledge of ICH/GCP guidelines; maintains current medical/scientific/regulatory knowledge. Demonstrated project management skills including managing multiple projects; strong planning, time management, and coordination abilities. Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. We discover, develop and deliver innovative therapies for patients in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use strategic platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and address unmet medical needs. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers lifesaving therapies to people in more than 100 countries. We value inclusion and belonging and strive to reflect the world around us. Learn more about our commitment to inclusion and belonging.
#J-18808-Ljbffr
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Associate Director, Global Feasibility Lead
is responsible for leading the strategic planning and execution of global feasibility assessments across clinical development programs. This role ensures that feasibility activities are data-driven, regionally informed, and aligned with the broader clinical and operational strategy. Operating within a matrixed and cross-functional environment, the Associate Director partners with therapeutic area leads, clinical operations, and external service providers to deliver robust feasibility insights that inform country and site selection, enrollment forecasting, and risk mitigation strategies. The role also oversees the development and deployment of feasibility tools, manages feasibility data integrity, and ensures timely delivery of feasibility outputs to support protocol finalization and study startup. This position plays a critical role in early engagement with investigators and sites, shaping the feasibility narrative and contributing to the operational design of clinical trials. The Associate Director is expected to proactively identify feasibility risks, propose mitigation strategies, and escalate issues as needed to ensure successful trial execution. Responsibilities
Feasibility Strategy Development: Lead the design and implementation of global feasibility strategies to support protocol optimization and country/site selection. Cross-Functional Collaboration: Partner with clinical operations, therapeutic area leads, and external vendors to gather input and align feasibility outputs with study needs. Data Analysis & Forecasting: Analyze historical data, epidemiology, and site performance metrics to generate enrollment forecasts and identify potential risks. Feasibility Tool Management: Oversee the development and deployment of feasibility tools and templates to ensure consistency and quality across programs. Stakeholder Engagement: Facilitate early engagement with investigators and sites to validate feasibility assumptions and support study startup planning. Act as the primary point of contact both internally and externally for study-related matters (e.g., vendors). Maintain up-to-date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations. Support audits/inspections and resolution of findings. Support development of new SOPs, guidelines, and participation in working groups on new processes. Functional leadership and mentorship of junior staff; advise other ClinOps colleagues within and across therapeutic areas. Provide oversight and direction for assigned studies/programs, ensuring appropriate delegation, inter-program efficiencies, and applied learnings. Job Qualifications And Experience
Education At minimum, bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related area preferred. Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist). Experience Minimum of 10 years’ relevant clinical research (or related) experience within the pharmaceutical industry. Solid understanding of the drug development process and each step within the clinical trial process. Experience in running feasibility activities for large and/or complex global clinical trials. Robust budget forecasting and management experience. Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process. Competencies Demonstrated ability to lead teams and work in a fast-paced team environment. Experience in working within a matrix environment and resolving interpersonal conflicts. Ability to mentor and coach others through peer-to-peer interactions and develop personnel in complex clinical project management. Ability to evaluate, judge, and make decisions regarding staff; able to teach/coaching and model best practices. Excellent interpersonal and decision-making skills. Demonstrates innovation, drive, energy, and enthusiasm to deliver program objectives. Skilled at independently navigating new indications, study/program approaches, and unique challenges. Strong understanding of all tasks involved in a clinical development program from protocol development to final clinical study report. Ability to plan, execute, and complete clinical programs to high ethical and scientific standards. Extensive knowledge of ICH/GCP guidelines; maintains current medical/scientific/regulatory knowledge. Demonstrated project management skills including managing multiple projects; strong planning, time management, and coordination abilities. Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. We discover, develop and deliver innovative therapies for patients in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use strategic platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and address unmet medical needs. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers lifesaving therapies to people in more than 100 countries. We value inclusion and belonging and strive to reflect the world around us. Learn more about our commitment to inclusion and belonging.
#J-18808-Ljbffr