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 Cardio-Re5+ 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 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!