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Senior scientist - clinical pharmacology

München
Tubulis GmbH
Scientist
Inserat online seit: 11 März
Beschreibung

As Senior Scientist clinical pharmacology, you will serve as the clinical pharmacology representative in clinical study teams and cross-functional project teams. You will ensure adequate collection and management of clinical pharmacology data across our Tubulis clinical studies and perform exploratory analyses of pharmacokinetic (PK) and pharmacodynamic (PD) data to support dose selection and clinical decision making.

Joining this team means contributing to the translation of our-next generation antibody-drug-conjugate (ADC) technologies into meaningful patient outcomes.

Your mission

* Represent Clinical Pharmacology in clinical trial and cross-functional project teams
* Ensure adequate collection and management of clinical pharmacology data across clinical studies
* Authoring and review of clinical pharmacology aspects of clinical study protocols, analysis plans, reports and related regulatory documents
* Perform non-compartmental analyses (NCA) of clinical PK data
* Exploratory analysis of PK/PD and exposure response data to support decision-making
* Engage with and manage outside vendors, including oversight and review of population PK and PKPD analyses conducted by third party vendors

Your profile

Essential Qualifications:

* PhD, PharmD, or equivalent in Clinical Pharmacology or Life Sciences.
* Minimum of 4 years of industry experience in clinical pharmacology
* Strong expertise in analysis, interpretation and reporting of pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity study results.
* Practical experience in representing the clinical pharmacology function in clinical study teams
* Practical experience in interacting with and overseeing third party vendors
* Hands-on experience with PKPD and data analysis software (e.g. R, Monolix, Phoenix WinNonlin)
* Excellent knowledge and understanding of clinical trial regulations including GCP guidelines, FDA/EMA regulations, and other regulatory requirements.

Preferred Qualifications:

* Excellent communication and organizational skills
* Ability to work independently and collaboratively in a fast-paced environment
* Fluent in English; knowledge of German is a plus
* Experience in oncology is a plus
* Experience addressing questions from regulatory health authorities is a plus

Why us?

At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.

* Impact that matters : Contribute to breakthrough therapies.
* Global mindset : Work in an international, diverse team.
* Grow & thrive : Develop your career in a supportive, fast-moving environment.
* Innovation every day : Push boundaries with cutting-edge science.

At Tubulis, your ideas matter, your growth matters—and together, we make a difference.

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