Director of Clinical Development
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 Clinical Science Director? This position is located in our King of Prussia PA, Marburg Germany or Bern Switzerland office.
It is a Hybrid role.
You will report to the Global Clinical Lead.
The OpportunityYou will use your MD degree and Clinical Development experience to take global responsibility for medical oversight of selected pipeline and products within the assigned therapeutic area(s).
You will be responsible for.
medical standards and processes according to expectations of manufacturers by all partners including regulators, governmental agencies, payors, physicians, patients and the general public.
The Role You will provide medical expertise for clinical study oversight and safety concerns within the assigned therapeutic area as the Medical monitor.
Present results to Safety Monitoring Committee and other internal and external meetings.
Provide medical and scientific input for the safe, efficient, and execution of assigned clinical programs.
Review the data generated during the execution of a study to gather a medical understanding of the safety and efficacy results and the impact of the data on ongoing R&D strategies and provides support in defining the development strategy.
Responsible or participate in the ongoing data reviews.
Contribute to the drafting/review of clinical study protocol/reports and other documents.
Provide medical insight to the draft or draft responses to regulatory agencies and IRBs/ECs or other regulatory documents.
Set technical medical strategies for global projects and therapeutic areas, consistent with functional expectations.
Identify potential challenges, risks and roadblocks associated with the global medical strategy and work as a leader in developing solutions to address these, working and inter-functionally with other departments.
Your experience Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
2
years as a physician in patient care.
3
years pharmaceutical / biotechnology industry experience, with 1year including accountability for medical oversight/evaluation or clinical development Academic- And -Industry experience in Solid Organ Transplantation would be useful.
Experience addressing and managing complex medical issues in the pre-approval and post-approval environment.
BENEFITS Medical, Dental Vision 401K Paid time Off #LI-HybridOur BenefitsCSL 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 BehringCSL 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 usAs 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! Recommended Skills Biotechnology Clinical Works Health Care Transplanting Pharmaceuticals Clinical Development Estimated Salary: $20 to $28 per hour based on qualifications.
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 Clinical Science Director? This position is located in our King of Prussia PA, Marburg Germany or Bern Switzerland office.
It is a Hybrid role.
You will report to the Global Clinical Lead.
The OpportunityYou will use your MD degree and Clinical Development experience to take global responsibility for medical oversight of selected pipeline and products within the assigned therapeutic area(s).
You will be responsible for.
medical standards and processes according to expectations of manufacturers by all partners including regulators, governmental agencies, payors, physicians, patients and the general public.
The Role You will provide medical expertise for clinical study oversight and safety concerns within the assigned therapeutic area as the Medical monitor.
Present results to Safety Monitoring Committee and other internal and external meetings.
Provide medical and scientific input for the safe, efficient, and execution of assigned clinical programs.
Review the data generated during the execution of a study to gather a medical understanding of the safety and efficacy results and the impact of the data on ongoing R&D strategies and provides support in defining the development strategy.
Responsible or participate in the ongoing data reviews.
Contribute to the drafting/review of clinical study protocol/reports and other documents.
Provide medical insight to the draft or draft responses to regulatory agencies and IRBs/ECs or other regulatory documents.
Set technical medical strategies for global projects and therapeutic areas, consistent with functional expectations.
Identify potential challenges, risks and roadblocks associated with the global medical strategy and work as a leader in developing solutions to address these, working and inter-functionally with other departments.
Your experience Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
2
years as a physician in patient care.
3
years pharmaceutical / biotechnology industry experience, with 1year including accountability for medical oversight/evaluation or clinical development Academic- And -Industry experience in Solid Organ Transplantation would be useful.
Experience addressing and managing complex medical issues in the pre-approval and post-approval environment.
BENEFITS Medical, Dental Vision 401K Paid time Off #LI-HybridOur BenefitsCSL 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 BehringCSL 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 usAs 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! Recommended Skills Biotechnology Clinical Works Health Care Transplanting Pharmaceuticals Clinical Development Estimated Salary: $20 to $28 per hour based on qualifications.
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