BioSpace, Inc.
Senior Director Clinical Development Nephrology
BioSpace, Inc., King Of Prussia, Pennsylvania, United States, 19406
Job Details
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 Senior Director Clinical Development? This is a hybrid role located in our King of Prussia PA or Marburg Germany office. You will report to the Physician Lead.
The Clinical Program Leader is a critical role within Clinical Development and accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment with global responsibility for medical oversight of selected pipeline and products within.
Manage the daily operations of the CDT including meeting coordination and documentation and partner management.Develop the Clinical Development Plan (CDP).Ensure that the program is conducted with CSL Behring processes and abiding by GCP and ICH regulations.This position is accountable for the medial oversight of the assigned program and:
Ensure medical standards are met during the programProvide medical oversight and expertise during development of clinical studiesBe a medical monitor for assigned clinical trialsBe a Clinical Development medical representative on the required Delivery Teams (DT)You are the "Lead Author" or "Contributing Author" for:
Main study documents, including Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR).the clinical sections of relevant regulatory packages (e.g. IND, NDA, annual reports) and support regulatory RFIs.Qualifications:
MD (Medical Doctor degree) or international equivalent plus accredited residency.Two (4) years minimum experience as a physician in patient care, preferably in the field of Nephrology5+ years pharmaceutical / biotechnology industry experience, which include accountability for medical oversight/evaluation or clinical development.Industry experience in designated therapeutic area(s).Previous line/matrix management experience and a record of accomplishments in managing people.Experience and success in addressing and managing complex medical issues in the pre-approval and post-approval environment.BENEFITS
Medical, Dental Vision401KPaid time Off
#LI-Hybrid
Our BenefitsWe encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL .
We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL!
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 Senior Director Clinical Development? This is a hybrid role located in our King of Prussia PA or Marburg Germany office. You will report to the Physician Lead.
The Clinical Program Leader is a critical role within Clinical Development and accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment with global responsibility for medical oversight of selected pipeline and products within.
Manage the daily operations of the CDT including meeting coordination and documentation and partner management.Develop the Clinical Development Plan (CDP).Ensure that the program is conducted with CSL Behring processes and abiding by GCP and ICH regulations.This position is accountable for the medial oversight of the assigned program and:
Ensure medical standards are met during the programProvide medical oversight and expertise during development of clinical studiesBe a medical monitor for assigned clinical trialsBe a Clinical Development medical representative on the required Delivery Teams (DT)You are the "Lead Author" or "Contributing Author" for:
Main study documents, including Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR).the clinical sections of relevant regulatory packages (e.g. IND, NDA, annual reports) and support regulatory RFIs.Qualifications:
MD (Medical Doctor degree) or international equivalent plus accredited residency.Two (4) years minimum experience as a physician in patient care, preferably in the field of Nephrology5+ years pharmaceutical / biotechnology industry experience, which include accountability for medical oversight/evaluation or clinical development.Industry experience in designated therapeutic area(s).Previous line/matrix management experience and a record of accomplishments in managing people.Experience and success in addressing and managing complex medical issues in the pre-approval and post-approval environment.BENEFITS
Medical, Dental Vision401KPaid time Off
#LI-Hybrid
Our BenefitsWe encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
About CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL .
We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL!