Director Companion Diagnostics Lead

vor 4 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**:We are looking for a dedicated Director Companion Diagnostics (CDx) Lead who is passionate about driving innovation in the field of Precision Medicine and making a meaningful impact. In this role, you will be instrumental in the development and execution of CDx strategies and in driving CDx projects to support Precision Medicine based drug developments. You will lead CDx projects considering the needs of the therapeutic program, technological advancements and a dynamically changing regulatory and competitive environment. You will work collaboratively with external diagnostic partners to ensure the successful and timely delivery of CDx projects while adhering to budget and regulatory requirements. Additionally, you will be responsible for evaluating new CDx partners and technologies, representing the CDx function in global program teams, and communicating CDx strategies to internal governance bodies. You will strongly collaborate with cross-functional teams to ensure successful implementation of biomarker testing in clinical trials and provide support to commercial functions from a diagnostic perspective. If you are ready to take on this exciting opportunity, we encourage you to apply

**Who you are**:

- PhD or equivalent with a minimum of 8 years of experience in the pharmaceutical and/or diagnostics industry, including 5+ years in a similar role.
- In-depth expertise in CDx product development, regulatory requirements, and commercialization aspects.
- Proficiency in diagnostics technologies such as NGS, PCR/dPCR, and IHC.
- Expertise in Precision Medicine clinical developments in Oncology; experience in antibody-drug conjugates and/or DNA damage repair is a plus.
- Proficient in writing and reviewing documents supporting regulatory submissions.
- Familiarity with clinical laboratory and medical device quality requirements.
- Proven track record in a matrix leadership role and managing external partners.
- Ability to work effectively in multidisciplinary pharmaceutical/diagnostic teams.
- Excellent communication and presentation skills, with the ability to lead, influence, and inspire others. Willingness to travel domestically and internationally, up to 20%.

**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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