Lead Clinical Scientist – Drug Development (m|f|d)

As a Lead Clinical Scientist in Clinical Drug Development you will take on both strategic and operational responsibilities in advancing innovative therapies in autoimmune diseases oncology with a focus on advanced therapy medicinal products (ATMPs) including cell and gene therapies.

• In this role you contribute to the development and execution of global clinical development plans (Phases IIII) ensuring scientific excellence and regulatory alignment.
• Additionally the design drafting and review of clinical trial protocols amendments and study-related documents fall within your scope of responsibility.
• A key focus lies in ensuring the generation of high-quality clinical data and supporting the preparation of regulatory submissions (e.g. IND CTA BLA MAA).
• Close collaboration with cross-functional teams; including medical regulatory biometrics operations CMC and safety; is essential as is representing Clinical Development in internal and external settings.
• Next to this you support the professional development of junior scientists and contribute to establishing team-wide standards processes and best practices.

Qualifications :

• You hold an advanced degree (PhD MD PharmD or equivalent) in life sciences medicine or a related field paired with significant experience in clinical development within the pharmaceutical or biotech industry ideally including exposure to advanced therapy medicinal products (ATMPs) and/or CAR-T therapies.
• You have a proven track record in protocol development regulatory submissions (IND CTA BLA MAA) and clinical data interpretation and are recognized as an expert in the end-to-end process of clinical data generation from protocol design through to final reporting.
• You demonstrate comprehensive expertise across the clinical data lifecycleworking backwards from the desired final readouts to plan early for the necessary data overseeing capture coordinating cleaning and integrity checks and obtaining study results in collaboration with biostatistics programming data management and medical monitoring teamsensuring outputs that are decision-ready for regulatory and clinical use.
• You integrate translational insights biomarkers and clinical endpoints into development plans and work effectively across a matrix environment of internal stakeholders external collaborators and CRO partners to ensure alignment from early research through late-stage clinical development.
• As an integral team member of Clinical Drug Development you communicate complex scientific data clearly and effectively in English both in writing and speaking and leadership by coaching mentoring and educating less experienced colleagues while upholding high scientific and operational standards.

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 :

No

Employment Type :

Full-time

Key Skills
Fire Protection,Attorney At Law,Cost Estimation,Cloud Services,Art & Design
Experience: years
Vacancy: 1