Director Clinical Biomarker Lead

vor 6 Monaten

Darmstadt, Deutschland Merck KGaA Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your Role**

The Clinical Biomarker Lead is a key role within our organization, responsible for driving development and implementation of end-to-end and fit-for-purpose clinical biomarker strategies to characterize disease mechanisms, support dose finding and enable patient stratification/selection within our development programs. As the Director Clinical Biomarker Lead Oncology, you will lead a cross-functional biomarker team in a matrix structure and collaborate with these expert functions to develop and execute the biomarker strategy according to agreed timelines & budget. You support biomarker-relevant aspects of global regulatory interactions and filings, including drug and CDx submissions.

In this senior role, you serve as an ambassador for the clinical biomarker function, both within and outside the company. You oversee and communicate new scientific and clinical development aspects relevant for successful precision oncology approaches. Building on your expertise you are able to support the evaluation of opportunities for collaboration, licensing, and acquisition of assets to enrich the oncology pipeline.

**Who you are**
- PhD or MD degree or equivalent with 8+ years of experience in oncology clinical biomarkers/translational research in the pharmaceutical or biotech industry
- Expert in biomarker-driven clinical development (ideally track record of contribution to regulatory submissions & filings)
- Strong scientific background (publication track record) in oncology translational sciences; proven expertise in the fields of antibody-drug conjugates, DNA damage and repair and/or immune-oncology is a plus
- In-depth understanding of biomarker technologies
- Knowledge of regulatory requirements for predictive biomarkers and derived CDx strategies
- Solid understanding of the operational considerations for executing biomarker strategies in clinical development
- Personal track record in a matrix leadership role
- Excellent communication and presentation skills; ability to lead, influence, and inspire others Strong interpersonal skills and ability to work effectively in multidisciplinary pharmaceutical/diagnostic teams

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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