BioSpace, Inc.
Associate Director, Site Management and Monitoring Oversight
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.
Could you be our next Associate Director, Site Management and Monitoring Oversight? The job is in our King of Prussia PA, Waltham MA or Melbourne Australia office. This is a hybrid position and is onsite three days a week. You will report to the Senior Director Head of Site Management & Monitoring.
You will be responsible for clinical operations strategic leadership to ensure conduct and oversight of monitoring and site management of clinical programs in the designated region following our strategy, appropriate international regulatory standards, and within the agreed timeframe and budget. This role will be the strategic interface between therapeutic areas and study management to ensure the quality of the delivery of the clinical program(s) at the site level. The Associate Director will oversee the permanent and functional service provider site management staff and build a strategic relationship with service providers and CROs at a regional level.
Responsibilities:
Strategic Leadership & Oversight Lead regional clinical operations strategy aligned with global clinical development goals. Ensure monitoring and site management activities meet international regulatory standards, timelines, and budget targets. Oversee the quality and consistency of clinical program execution at the site level. Vendor & CRO Management
Build and maintain strategic relationships with service providers and CROs. Oversee permanent and functional service provider staff involved in site management. Operational Excellence
Drive continuous improvement in site performance and monitoring practices. Identify and mitigate risks to ensure smooth clinical trial execution. Cross-Functional Collaboration
Collaborate with internal stakeholders across clinical development, regulatory, and data management. Ensure alignment between regional execution and global clinical strategy. Compliance & Governance
Ensure adherence to GCP, ICH, and applicable regulatory requirements. Support audit readiness and inspection preparedness across regional sites. 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.
QUALIFICATIONS:
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred 10 years' relevant clinical research (or related) experience within the pharmaceutical industry. Previous experience in leading and managing a team of professional staff. A solid understanding of the drug development process, and specifically, each step within the clinical trial process. Experience in site management and monitoring and overseeing 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 #LI-HYBRID
Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
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.
Could you be our next Associate Director, Site Management and Monitoring Oversight? The job is in our King of Prussia PA, Waltham MA or Melbourne Australia office. This is a hybrid position and is onsite three days a week. You will report to the Senior Director Head of Site Management & Monitoring.
You will be responsible for clinical operations strategic leadership to ensure conduct and oversight of monitoring and site management of clinical programs in the designated region following our strategy, appropriate international regulatory standards, and within the agreed timeframe and budget. This role will be the strategic interface between therapeutic areas and study management to ensure the quality of the delivery of the clinical program(s) at the site level. The Associate Director will oversee the permanent and functional service provider site management staff and build a strategic relationship with service providers and CROs at a regional level.
Responsibilities:
Strategic Leadership & Oversight Lead regional clinical operations strategy aligned with global clinical development goals. Ensure monitoring and site management activities meet international regulatory standards, timelines, and budget targets. Oversee the quality and consistency of clinical program execution at the site level. Vendor & CRO Management
Build and maintain strategic relationships with service providers and CROs. Oversee permanent and functional service provider staff involved in site management. Operational Excellence
Drive continuous improvement in site performance and monitoring practices. Identify and mitigate risks to ensure smooth clinical trial execution. Cross-Functional Collaboration
Collaborate with internal stakeholders across clinical development, regulatory, and data management. Ensure alignment between regional execution and global clinical strategy. Compliance & Governance
Ensure adherence to GCP, ICH, and applicable regulatory requirements. Support audit readiness and inspection preparedness across regional sites. 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.
QUALIFICATIONS:
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred 10 years' relevant clinical research (or related) experience within the pharmaceutical industry. Previous experience in leading and managing a team of professional staff. A solid understanding of the drug development process, and specifically, each step within the clinical trial process. Experience in site management and monitoring and overseeing 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 #LI-HYBRID
Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
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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