Associate Director Clinical Biomarkers & CDx (all genders), full/part-time possible

Merck Gruppe; Darmstadt; Vor Ort; EUR 65.000 - 110.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen Clinical Biomarker Lead, der die strategische Entwicklung und Implementierung klinischer Biomarker leitet. In dieser Schlüsselrolle arbeiten Sie mit einem interdisziplinären Team zusammen, um die Entwicklung von Medikamenten in den Bereichen Neurologie und Immunologie voranzutreiben. Sie bringen Ihre Expertise ein, um die Patientenstratifizierung zu unterstützen und die regulatorischen Anforderungen zu erfüllen. Diese Position bietet die Möglichkeit, in einem dynamischen Umfeld zu arbeiten, in dem Ihre Beiträge einen bedeutenden Einfluss auf die Patientenversorgung haben werden. Wenn Sie leidenschaftlich an Wissenschaft und Technologie interessiert sind, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• 5+ Jahre Erfahrung in klinischen Biomarkern und translationaler Forschung.
• Nachgewiesene Erfolge in der biopharmazeutischen Entwicklung.

Aufgaben

• Leitung eines biomarker-Teams zur Entwicklung von Strategien.
• Präsentation von biomarker-Paketen auf Studien- und Programmebene.

Kenntnisse

Biomarker-Entwicklung

Translational Research

Präsentationsfähigkeiten

Kommunikationsfähigkeiten

Stakeholder-Management

Ausbildung

PhD/MD oder gleichwertig

Tools

GxP-Standards

Jobbeschreibung

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, accountable for delivering fit-for-purpose clinical biomarker strategies to support dose finding, go/no go decisions to reach program milestones, demonstrate mechanism of action, and enable patient stratification in our programs throughout the development lifecycle.

As an Associate Director Clinical Biomarker Lead Neurology & Immunology (N&I), you will lead a cross-functional biomarker team of subject matter experts to collaboratively develop and execute the clinical biomarker strategy in alignment with the clinical development plan according to agreed timelines & budget. You serve as the biomarker point of contact for clinical studies, represent the program biomarker team to management/governance, and support biomarker-relevant aspects of global regulatory interactions and filings. Building on your expertise, you also support the evaluation of opportunities for collaboration, licensing, and acquisition to further enrich the N&I pipeline.

Key Accountabilities:

• Presenting strategy-driven biomarker packages at study and program level meetings, as well as communicating these to senior leadership.
• Provide strategic leadership and gain broad, cross-functional alignment of biomarker strategies.
• Developing strategic vision and lead implementation for clinical biomarkers that will broadly enable advances in indication selection, biological activity and patient stratification/selection.
• Oversee and manage Precision Medicine deliverables for the assigned programs with responsibility for end to end, high-quality implementation and execution of strategy by collaborating with other functions, including but not limited to Clinical Operations and Quantitative Pharmacology.

Who You Are

Minimum Qualifications:

• PhD/MD or equivalent with 5+ years of relevant work experience.
• Demonstrated experience in clinical biomarkers and/or translational research within the pharmaceutical or biotech industry with a proven track record of contributions to biomarker-driven clinical drug development.
• Expertise in the field of biomarkers for immunology, neurology and autoimmune disorders is a must for this position.

Preferred Qualifications:

• Strong scientific background (publication track record) in translational sciences.
• In-depth understanding of biomarker technologies.
• Strong understanding of clinical drug development strategies and quality related requirements under GxP.
• Understanding of the operational considerations for executing biomarker strategies in clinical development.
• Personal track record in a matrix leadership role.
• Strong presentation, communication, interpersonal, and stakeholder management skills.
• Ability to work effectively in multidisciplinary drug development teams by fostering scientific excellence, collaboration, data-driven decision-making, and a winning team culture.

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!

Apply now and become a part of our diverse team!