Director Clinical Portfolio Execution
3.
1 King of Prussia, PA King of Prussia, PA Full-time Full-time Estimated:
$142K - $180K a year Estimated:
$142K - $180K a year 12 hours ago 12 hours ago 12 hours 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.
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 Director, Global Clinical Operations? This position is located in our King of Prussia PA, Marburg Germany, Bern Switzerland or any other CSL office.
It is a Hybrid role.
You will report to the Senior Director of Clinical Operations.
THE ROLE Director-level position for an experienced clinical research manager working in a matrix environment.
You will have budget responsibility over $35Million/year, accountability for delivery in high-volume (# of studies) therapeutic areas (Transplant and Nephrology or Vaccines) and increased management responsibility - four or more Clinical Program Managers reporting to them with complex and visible clinical programs.
Provide clinical operations strategic leadership to, and management of all clinical programs within a designated Therapeutic Area (s) to ensure they are planned following our strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
Promote the Clinical Research Program(s), keeping informed about important developments in the therapeutic area including regulatory strategies and competitor status.
Be a primary contact with the CSD Therapeutic Area Head concerning Clinical Operations (including program timelines; budgets; and protocol development).
Standing member of all Core Project Teams within designated Therapeutic Areas Primary interface for partners (Regulatory/Commercial Operations/Commercial Development/Project Management) regarding operational delivery of clinical programs within a designated Therapeutic Area Manage main program risks and escalate to senior management Provide operational input to the Clinical Development Plan (including assessing the feasibility) and contribute to the program(s) strategy planning.
Improve the implementation of the clinical development plan within CRD to achieve program timelines.
Responsible for overall forecasts and management of clinical program(s) budgets and resource allocation in collaboration with the primary budget responsible member of the Clinical Operations team and Head of Clinical Operations.
Ensure clinical program is in compliance with ICH GCP, SOPs and regulatory requirements.
In collaboration with Clinical Development Personnel and Regional Clinical Operations Personnel, establishes links with investigators and main opinion leaders and appropriate professional bodies in the therapeutic area.
Manage a team of Clinical Program Managers and Clinical Study Managers, with responsibility for their coaching QUALIFICATIONS Bachelor's degree, or equivalent, in Science related discipline post graduate qualifications in scientific or business related field preferable.
10
years experience working in a Clinical Operations environment is required Leadership experience and global Clinical Operations experience is necessary.
BENEFITS Medical, Dental Vision 401K Paid time Off #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 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!.
Estimated Salary: $20 to $28 per hour based on qualifications.
1 King of Prussia, PA King of Prussia, PA Full-time Full-time Estimated:
$142K - $180K a year Estimated:
$142K - $180K a year 12 hours ago 12 hours ago 12 hours 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.
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 Director, Global Clinical Operations? This position is located in our King of Prussia PA, Marburg Germany, Bern Switzerland or any other CSL office.
It is a Hybrid role.
You will report to the Senior Director of Clinical Operations.
THE ROLE Director-level position for an experienced clinical research manager working in a matrix environment.
You will have budget responsibility over $35Million/year, accountability for delivery in high-volume (# of studies) therapeutic areas (Transplant and Nephrology or Vaccines) and increased management responsibility - four or more Clinical Program Managers reporting to them with complex and visible clinical programs.
Provide clinical operations strategic leadership to, and management of all clinical programs within a designated Therapeutic Area (s) to ensure they are planned following our strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
Promote the Clinical Research Program(s), keeping informed about important developments in the therapeutic area including regulatory strategies and competitor status.
Be a primary contact with the CSD Therapeutic Area Head concerning Clinical Operations (including program timelines; budgets; and protocol development).
Standing member of all Core Project Teams within designated Therapeutic Areas Primary interface for partners (Regulatory/Commercial Operations/Commercial Development/Project Management) regarding operational delivery of clinical programs within a designated Therapeutic Area Manage main program risks and escalate to senior management Provide operational input to the Clinical Development Plan (including assessing the feasibility) and contribute to the program(s) strategy planning.
Improve the implementation of the clinical development plan within CRD to achieve program timelines.
Responsible for overall forecasts and management of clinical program(s) budgets and resource allocation in collaboration with the primary budget responsible member of the Clinical Operations team and Head of Clinical Operations.
Ensure clinical program is in compliance with ICH GCP, SOPs and regulatory requirements.
In collaboration with Clinical Development Personnel and Regional Clinical Operations Personnel, establishes links with investigators and main opinion leaders and appropriate professional bodies in the therapeutic area.
Manage a team of Clinical Program Managers and Clinical Study Managers, with responsibility for their coaching QUALIFICATIONS Bachelor's degree, or equivalent, in Science related discipline post graduate qualifications in scientific or business related field preferable.
10
years experience working in a Clinical Operations environment is required Leadership experience and global Clinical Operations experience is necessary.
BENEFITS Medical, Dental Vision 401K Paid time Off #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 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!.
Estimated Salary: $20 to $28 per hour based on qualifications.
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