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Senior Medical Director, Global Clinical Development Oncology

L7

merckBillerica, MA44 days ago

Occupations

Physicians, All OtherMedical Scientists, Except EpidemiologistsNatural Sciences Managers

Industries

Research and Development in the Physical, Engineering, and Life SciencesResearch and Development in BiotechnologyOffices of Physicians
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 medical oncology.
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. You will 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.
Who You AreMinimum 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 IIIExperience 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
Preferred Requirements:
  • Experience in hematology/hematologic oncology
  • Experience across early and late clinical developmentExperience 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 developmentExperience mentoring, guiding, or managing medical team members
  • Strong strategic thinking, project leadership, and decision-making skills.
Key Competencies:
  • Strong clinical and scientific judgment in oncology
  • Strategic thinking and development leadership
  • Ability to translate complex clinical and scientific data into development strategy
  • Effective leadership in cross-functional and global matrix teams with a team-player mentality
  • Clear and persuasive communication
  • Ownership, accountability, and execution focus
  • Comfort working in a fast-paced, global organization
Location: Billerica, MA, USA; Onsite (Hybrid)
Travel:
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Level

ManagerL7

Location

Billerica, MA

Occupation

Physicians, All Other

Industry

Research and Development in the Physical, Engineering, and Life Sciences

Posted

44 days ago

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