Senior Medical Director, Global Clinical Development Oncology

Merck•Billerica, MA

6d•Hybrid

About The Position

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).

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 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 targeted therapies, ADCs, immuno-oncology, and/or 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 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.
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.