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

Merck Group; Deutschland; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Clinical Biomarker Lead to drive innovative strategies in drug development. This role involves leading a cross-functional team, overseeing biomarker strategies, and ensuring high-quality execution in clinical studies. The ideal candidate will possess a PhD/MD and extensive experience in clinical biomarkers, particularly in immunology and neurology. Join a diverse and inclusive culture that values your contributions and fosters personal growth while making a significant impact on patient lives.

Qualifikationen

• 5+ years of relevant experience in clinical biomarkers and drug development.
• Expertise in immunology, neurology, and autoimmune disorders is essential.

Aufgaben

• Lead cross-functional biomarker teams to develop clinical strategies.
• Present biomarker strategies to senior leadership and stakeholders.

Kenntnisse

Clinical Biomarkers

Translational Research

Stakeholder Management

Matrix Leadership

Communication Skills

Ausbildung

PhD/MD or equivalent

Tools

Biomarker Technologies

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!