CSL Behring
Associate Director Clinical Portfolio Execution
CSL Behring, King of Prussia, Pennsylvania, United States,
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next AD, Clinical Portfolio Execution? This position is located in our King of Prussia PA, Waltham MA, Marburg Germany, Bern Switzerland or Amsterdam office. It is a Hybrid role. You will report to the Director Clinical Portfolio Execution.
You will develop the operational strategy for clinical studies and clinical programs and the end-to-end study delivery of all operational activities and budget management relating to assigned clinical studies. You will manage one or more studies/products, often the most complex in size, and may take on additional responsibilities as defined by the (Sr) Director Clinical Portfolio Execution. This role may also, if assigned, provide oversight and direction to studies run by (Sr) Global Trial Leaders.
Responsibilities:
Lead the SET and coordinate with functional area representatives on all study-related activities ensuring timelines, budget, and quality are maintained.
Project management of a clinical study from protocol development up to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving.
Develop study timelines and budget.
Ensure regulatory compliance and GCP compliance.
Contribute to operational aspects of the protocol.
Contribute to feasibility, country strategy, and enrollment plans.
Develop and implement the clinical operational strategy plan, study management plan, and associated documents.
Lead vendor selection and management/oversight, including issue escalation.
Lead a team ensuring EC/IRB and regulatory submissions.
Ensure internal and external study team members are trained on the protocol and study processes, which includes organization of investigator meetings.
Develop proactive risk mitigation strategy and corrective action plan to address study issues in collaboration with SET.
Responsible for oversight of TMF, always ensuring inspection readiness.
Report main study performance information, including study start-up metrics, enrollment, data collection.
Be a primary contact both internally and externally (e.g., vendors) as applicable for anything study-related.
Support audits/inspections and resolutions of findings.
Support in the development of new SOPs, guidelines, etc., or participate in working groups about new processes.
Qualifications:
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related area.
Other degrees and certifications considered if determined by related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
10+ years' clinical research experience within the pharmaceutical industry.
Knowledge of the drug development process, and specifically, each step within the clinical trial process.
Experience overseeing large global clinical trials (pharmaceutical or CRO).
Budget forecasting and management experience.
Knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
BENEFITS:
Medical, Dental Vision.
401K.
Paid time Off.
#LI-Hybrid
About CSL Behring:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular, and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
#J-18808-Ljbffr
With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next AD, Clinical Portfolio Execution? This position is located in our King of Prussia PA, Waltham MA, Marburg Germany, Bern Switzerland or Amsterdam office. It is a Hybrid role. You will report to the Director Clinical Portfolio Execution.
You will develop the operational strategy for clinical studies and clinical programs and the end-to-end study delivery of all operational activities and budget management relating to assigned clinical studies. You will manage one or more studies/products, often the most complex in size, and may take on additional responsibilities as defined by the (Sr) Director Clinical Portfolio Execution. This role may also, if assigned, provide oversight and direction to studies run by (Sr) Global Trial Leaders.
Responsibilities:
Lead the SET and coordinate with functional area representatives on all study-related activities ensuring timelines, budget, and quality are maintained.
Project management of a clinical study from protocol development up to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving.
Develop study timelines and budget.
Ensure regulatory compliance and GCP compliance.
Contribute to operational aspects of the protocol.
Contribute to feasibility, country strategy, and enrollment plans.
Develop and implement the clinical operational strategy plan, study management plan, and associated documents.
Lead vendor selection and management/oversight, including issue escalation.
Lead a team ensuring EC/IRB and regulatory submissions.
Ensure internal and external study team members are trained on the protocol and study processes, which includes organization of investigator meetings.
Develop proactive risk mitigation strategy and corrective action plan to address study issues in collaboration with SET.
Responsible for oversight of TMF, always ensuring inspection readiness.
Report main study performance information, including study start-up metrics, enrollment, data collection.
Be a primary contact both internally and externally (e.g., vendors) as applicable for anything study-related.
Support audits/inspections and resolutions of findings.
Support in the development of new SOPs, guidelines, etc., or participate in working groups about new processes.
Qualifications:
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related area.
Other degrees and certifications considered if determined by related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
10+ years' clinical research experience within the pharmaceutical industry.
Knowledge of the drug development process, and specifically, each step within the clinical trial process.
Experience overseeing large global clinical trials (pharmaceutical or CRO).
Budget forecasting and management experience.
Knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
BENEFITS:
Medical, Dental Vision.
401K.
Paid time Off.
#LI-Hybrid
About CSL Behring:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular, and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
#J-18808-Ljbffr