Senior Clinical Trial Physician (m|f|d)

Bergisch Gladbach - Germany

Monthly Salary: Not Disclosed

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

As a Senior Clinical Trial Physician you will play a pivotal role in providing medical leadership and scientific expertise to ensure the successful planning execution and supervision of clinical trials in hemato-oncology. You will contribute to study design regulatory submissions data review and publications while collaborating closely with cross-functional teams to maintain the highest standards of patient safety and regulatory compliance.

As a valuable member of the Medical Science team:

You will lead the design and implementation of clinical trial protocols ensuring adherence to ICH-GCP ethical standards and regulatory requirements.
You will provide medical supervision of ongoing trials working closely with Clinical Operations and vendor Medical Monitors and support protocol amendments as needed.
You will review and analyze clinical trial data contributing to Clinical Study Reports (CSRs) MAA/BLA submissions and other regulatory documentation.
Next to this you will support the development of scientific publications and presentations serving as a medical and scientific interface to internal and external stakeholders including KOLs.
You will ensure regulatory compliance providing medical guidance on safety adverse events and study conduct and contributing to the preparation of regulatory submission packages.
In addition you will work closely with cross-functional teams including Clinical Operations Regulatory Affairs Biostatistics and external partners to ensure the smooth execution of clinical programs and foster a culture of scientific excellence and accountability.

Qualifications :

As a Senior Clinical Trial Physician you ideally hold a medical degree (MD) with valid license to practice; board certification in hemato-oncology is strongly preferred.

You bring a strong medical and scientific background in hemato-oncology with proven experience in clinical trial design execution and supervision.
You have experience with regulatory submissions (MAA/BLA) and scientific publications.
You have industry experience in Pharma/Biotech ideally in a cross-functional global clinical development setting.
You are highly organized detail-oriented and proactive with the ability to take ownership and make decisions in a fast-paced environment.
You are an excellent communicator and collaborator able to work effectively with Clinical Operations Regulatory Biostatistics KOLs and other stakeholders.
You are committed to patient safety regulatory compliance and scientific integrity in all aspects of your work.

Additional Information :

What we offer

Working with free and self-determined time management also mobile working
An intercultural environment characterized by diversity and flat hierarchies
Freedom to contribute creatively and play an active role in shaping the company
Individual further training in our Miltenyi University as the core of the Miltenyi DNA
30 days of vacation discounted ticket to Germany (e)-bike leasing capital-forming benefits company pension plan disability insurance canteen and much more.

Diversity is the bedrock of our creativity

Our mission: To innovate treatments and technologies and tackle the worlds most serious health challenges. And thats why we connect the dots across various disciplines linking different perspectives skills and abilities.

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability.

Become part of our team and focus on pushing the borders of medicine.

We look forward to your application

If you want to work in an open creative and supportive team this is the place for you. We look forward to receiving your application along with your salary expectations and availability.

Remote Work :

Employment Type :

Full-time

As a valuable member of the Medical Science team:

You will lead the design and implementation of clinical trial protocols ensuring adherence to ICH-GCP ethical standards and regulatory requirements.
You will provide medical supervision of ongoing trials working closely with Clinical Operations and vendor Medical Monitors and support protocol amendments as needed.
You will review and analyze clinical trial data contributing to Clinical Study Reports (CSRs) MAA/BLA submissions and other regulatory documentation.
Next to this you will support the development of scientific publications and presentations serving as a medical and scientific interface to internal and external stakeholders including KOLs.
You will ensure regulatory compliance providing medical guidance on safety adverse events and study conduct and contributing to the preparation of regulatory submission packages.
In addition you will work closely with cross-functional teams including Clinical Operations Regulatory Affairs Biostatistics and external partners to ensure the smooth execution of clinical programs and foster a culture of scientific excellence and accountability.

Qualifications :

As a Senior Clinical Trial Physician you ideally hold a medical degree (MD) with valid license to practice; board certification in hemato-oncology is strongly preferred.

You bring a strong medical and scientific background in hemato-oncology with proven experience in clinical trial design execution and supervision.
You have experience with regulatory submissions (MAA/BLA) and scientific publications.
You have industry experience in Pharma/Biotech ideally in a cross-functional global clinical development setting.
You are highly organized detail-oriented and proactive with the ability to take ownership and make decisions in a fast-paced environment.
You are an excellent communicator and collaborator able to work effectively with Clinical Operations Regulatory Biostatistics KOLs and other stakeholders.
You are committed to patient safety regulatory compliance and scientific integrity in all aspects of your work.

Additional Information :

What we offer

Working with free and self-determined time management also mobile working
An intercultural environment characterized by diversity and flat hierarchies
Freedom to contribute creatively and play an active role in shaping the company
Individual further training in our Miltenyi University as the core of the Miltenyi DNA
30 days of vacation discounted ticket to Germany (e)-bike leasing capital-forming benefits company pension plan disability insurance canteen and much more.

Diversity is the bedrock of our creativity

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability.

Become part of our team and focus on pushing the borders of medicine.

We look forward to your application

If you want to work in an open creative and supportive team this is the place for you. We look forward to receiving your application along with your salary expectations and availability.

Remote Work :

Employment Type :

Full-time

Key Skills

EMR Systems
Post Residency Experience
Occupational Health Experience
Pain Management
SOAP
Primary Care Experience
Medical Management
Suturing
Workers' Compensation Law
Pharmacy Residency
Botox Experience
Epic

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About Company

Miltenyi Biotec

For over 30 years, Miltenyi Biotec has been a major provider of products and services that drive biomedical research and boost cell and gene therapy. More than 4,700 employees in 23 countries combine excellence in research with innovative products to create cutting-edge solutions that ... View more

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