Senior Medical Director, Global Clinical Development Oncology
Merck GroupAbout the role
Work Your Magic with us! Start your next chapter and join EMD Serono.
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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
As a Senior Medical Director in Global Clinical Development Oncology, you will provide strategic, clinical, and scientific leadership for development programs in oncology. Your focus will be experience with drug development for solid tumors and ideally with experience in targeted therapies and antibody-drug conjugates (ADCs).
Key Accountabilities:
- Lead and shape clinical development strategy across the development continuum, from Phase 1 through Phase III, including registration-enabling activities, regulatory submissions, dossier contributions, and Health Authority interactions.
- Provide senior medical leadership on study design, execution, data interpretation, and key development decisions to support the advancement of oncology programs.
- Guide indication strategy, patient selection, dose optimization, and overall development pathways
- Integrate clinical, translational, and biomarker data into program decision-making
- Oversee review and interpretation of safety and efficacy data to support development decisions
- Drive and review key clinical and regulatory documents, including development plans, protocols, investigator brochures, clinical study reports, briefing books, submission documents, and dossiers
- Lead or shape registration-enabling activities and regulatory submission strategy
- Lead or represent Clinical Development in interactions with Health Authorities and internal governance bodies, as appropriate.
- Serve as a senior leader within cross-functional and global teams, partnering closely with Program Leadership and Management, Translational Medicine, Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology, Safety, and Medical Writing.
- Influence strategic direction, represent Clinical Development in key forums, and help ensure high-quality and timely delivery of development objectives in an office-based global environment.
- Partner effectively with cross-functional stakeholders across including Program Leadership and Management, Clinical Operations, Safety, Regulatory Affairs, Biostatistics, Clinical Pharmacology, Translational Medicine, and Medical Writing
- Provide strategic leadership within global matrix teams to ensure alignment, execution, and delivery against timelines
- Provide leadership and oversight to team members within Clinical development, as needed
- Contribute to business process improvement and organizational development initiatives, as appropriate.
Who You Are
Minimum Requirements:
- MD with expertise in clinical drug development
- Strong expertise in Oncology
- Minimum 5 years of industry experience in clinical R&D within pharma/biotech
- Experience leading or supporting clinical studies across Phase 1 through Phase III
- Experience contributing to clinical development strategy, registration-enabling activities, and regulatory submissions
- Familiarity with clinical dossiers, regulatory documentation, and interactions with Health Author
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