Senior Medical Director, Global Clinical Development Oncology

Merck•Billerica, MA

6d•Hybrid

About The Position

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. As a Senior Medical Director in Global Clinical Development Oncology, you will provide strategic, clinical, and scientific leadership for development programs in medical oncology.

Requirements

MD with expertise in clinical drug development
Strong expertise in Oncology, ideally with experience in solid tumors
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 Authorities
Demonstrated ability to interpret and apply clinical, translational, and biomarker data to development decisions
Experience leading cross-functional, matrixed, and international teams
Familiarity with ICH-GCP, FDA and/or EMA expectations, and clinical trial regulations
Excellent written and verbal communication skills in English
Ability to work effectively in an office-based environment and across global time zones

Nice To Haves

Experience in hematology/hematologic oncology
Experience across early and late clinical development
Experience with registration strategy and major regulatory submissions
Experience engaging with Health Authorities and internal governance forums
Experience with immuno-oncology, antibody-drug conjugates, targeted therapies, precision medicine, and/or biomarker-driven development
Experience mentoring, guiding, or managing medical team members
Strong strategic thinking, project leadership, and decision-making skills.

Responsibilities

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.
Guide indication strategy, patient selection, dose optimization, and overall development pathways.
Provide senior medical leadership on study design, execution, data interpretation, and key development decisions to support the advancement of oncology programs.
Serve as a senior leader within cross-functional and global teams, partnering closely with Program Leadership, 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.
Lead or represent Clinical Development in interactions with Health Authorities and internal governance bodies, as appropriate.
Mentor junior team members and contribute to a collaborative, high-performing development organization.
Contribute to business process improvement and organizational development initiatives, as appropriate.