- 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. You will be accountable for all deliverables to support the TAs. 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. Promote ownership of all deliverables through oversight and governance of the vendors.
- 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.
- Understanding of the drug development process, and specifically, each step within the clinical trial process.
- Experience overseeing global clinical trials (pharmaceutical or research institute).
- Knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
- Medical, Dental Vision
- 401K
- Paid time Off
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Associate Director Clinical Portfolio Execution - King of Prussia, United States - CSL Behring
Description
The Opportunity
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.
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 Associate Director, Clinical Portfolio Execution? The job can be located at any of our CSL locations.
As the Associate Director, Clinical Portfolio Execution you will develop the operational strategy for a clinical program and ensure the on-time delivery of a clinical program and remain within budget for an assigned Therapeutic Area.
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).The Role
Your experience
BENEFITS
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 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
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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law.
CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.
