BioSpace, Inc.
Associate Director, Global Feasibility Lead
BioSpace, Inc., King Of Prussia, Pennsylvania, United States, 19406
Job Details
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.
The
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.
Main Responsibilities and Accountabilities 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 (e.g., vendors) as applicable for anything study related. Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations. Support audits/inspections and resolutions of findings. Support in the development of new SOPs, guidelines etc and/ or participate in working groups about new processes. Functional leadership and mentorship of junior staff required; Act in advisory capacity to other clinops colleagues within and across TAs. When accountable to a set of studies and/or program (s) provides oversight and direction, ensuring appropriate delegation and delivery, inter-program efficiencies and applied learnings. Job Qualifications and Experience Requirements
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
As a guide, a minimum of 10 years' relevant clinical research (or related) experience within the pharmaceutical industry. A solid understanding of the drug development process, and specifically, 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. Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities. Ability to evaluate, judge and make decisions regarding staff. Ability to teach/coaching and setting an example of 'best practice'. Excellent interpersonal and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges. Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report. Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards. Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge. Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills. 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. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
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 its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL
Do work that matters at CSL Behring!
Company
CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people.
Areas of Expertise
We focus and demonstrate global leadership in three distinct areas-rare and serious diseases; influenza vaccines; and iron deficiency and nephrology.
Rare & Serious Diseases
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Vaccines
As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries.
Iron Deficiency & Nephrology
With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women's health, we help patients affected by these conditions to live better, healthier lives.
Company info Phone 610-878-4000 Location 1020 First Avenue King of Prussia Pennsylvania 19406 United States
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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.
The
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.
Main Responsibilities and Accountabilities 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 (e.g., vendors) as applicable for anything study related. Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations. Support audits/inspections and resolutions of findings. Support in the development of new SOPs, guidelines etc and/ or participate in working groups about new processes. Functional leadership and mentorship of junior staff required; Act in advisory capacity to other clinops colleagues within and across TAs. When accountable to a set of studies and/or program (s) provides oversight and direction, ensuring appropriate delegation and delivery, inter-program efficiencies and applied learnings. Job Qualifications and Experience Requirements
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
As a guide, a minimum of 10 years' relevant clinical research (or related) experience within the pharmaceutical industry. A solid understanding of the drug development process, and specifically, 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. Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities. Ability to evaluate, judge and make decisions regarding staff. Ability to teach/coaching and setting an example of 'best practice'. Excellent interpersonal and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges. Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report. Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards. Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge. Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills. 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. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
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 its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL
Do work that matters at CSL Behring!
Company
CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people.
Areas of Expertise
We focus and demonstrate global leadership in three distinct areas-rare and serious diseases; influenza vaccines; and iron deficiency and nephrology.
Rare & Serious Diseases
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Vaccines
As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries.
Iron Deficiency & Nephrology
With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women's health, we help patients affected by these conditions to live better, healthier lives.
Company info Phone 610-878-4000 Location 1020 First Avenue King of Prussia Pennsylvania 19406 United States
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