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Associate Director Clinical Portfolio Execution
3 months ago
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. You will report to the Senior Director, Clinical Portfolio Execution
You will be responsible for clinical operational planning activities and lead program projects. The Senior CPM manages two or more studies/or products and may take on additional responsibilities as defined by the Therapeutic Area Lead as dictated by project size and complexity. You will lead overall clinical project management, lead the study execution team (SET) and coordinates study execution at the global level. You will oversee the program/study level outsourcing, take preventive/corrective action(s) to address study/program level issues. You will manage/mentor Clinical Study Managers (CSMs) and Clinical Trial Assistants (CTAs).
Provide either strategic leadership to, and management of one or more clinical programs within or across a designated Therapeutic Area (TA) or is a member of a function that supports the delivery of the portfolio. These responsibilities include Study Operations, Business Operations and Compliance.
Ensure all activities that support the TA model are planned following our strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
You will negotiate or help negotiate CDAs, contractual terms, rate cards, and other contractual items with all vendors that support the TA model. At a study level, responsible for overall forecasts and management of budgets and resource allocation in collaboration with the Department Heads and clinical teams.
Develop or help develop the processes (e.g. eTMF) and standards to allow inspection readiness of all clinical studies and ensuring compliance with quality standards. Manage internal quality processes following defined standards to ensure that quality is built in upfront and checks are integrated into study activities.
Promote a culture of continuous improvement, always looking for ways to reduce cost and timelines, while maintaining excellent quality.
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area
~10+ years’ project management of Phase I-III clinical research experience in the pharmaceutical industry.
~ Experience overseeing global clinical trials (pharmaceutical or research institute).
~ Medical, Dental Vision
~CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. 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.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
