Medical Director, Global Clinical Development, Oncology

Barrington James; Boston (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

The position offers office-based work, with responsibilities spanning protocol authoring, biomarker integration, and regulatory submissions. English communication and board-certified oncology expertise are essential.

Qualifications

• MD with oncology-focused clinical drug development expertise.
• Experience supporting or leading trial programs from Phase 1 to Phase III.
• Familiarity with regulatory submissions and health authority interactions.
• Ability to integrate translational/biomarker data into development decisions.

Responsibilities

• Lead assigned clinical studies and contribute to program strategy from Phase 1 to Phase III.
• Integrate clinical, translational, biomarker data to support indication and dose strategy.
• Collaborate with cross-functional teams and Global Project Team across functions.
• Provide medical monitoring and oversight for studies and safety reviews.
• Draft and contribute to protocols, ICH documents, and regulatory submissions.
• Support interactions with Health Authorities and governance bodies.
• Drive milestones across global teams and timelines.
• Maintain high standards of scientific integrity and leadership.

Skills

Clinical drug development

Oncology expertise

Cross-functional collaboration

English communication

Medical writing

Education

MD

Job description

About The Opportunity

Our client is a global science and technology company with a growing healthcare business. They develop innovative medicines for patients across several therapeutic areas, with oncology at the core of their pipeline. They offer a diverse, inclusive and flexible culture, with real scope for personal development and career progression.

The role

As Medical Director in Global Clinical Development Oncology, you will provide clinical and scientific leadership for oncology development programs. Experience in targeted therapies, antibody-drug conjugates (ADCs) and/or immuno-oncology is ideal. Solid tumor drug development experience is expected, and hematology/hematologic oncology experience is viewed favorably.

You will independently drive day-to-day clinical development activities while contributing to the overall clinical strategy in a global matrix environment.

Key Responsibilities

• Lead assigned clinical studies and contribute to broader program strategy from Phase 1 through Phase III, including registration-enabling activities, regulatory submissions and Health Authority interactions
• Integrate clinical, translational, biomarker and emerging data to support indication strategy, patient selection, dose strategy and key development decisions
• Act as a core member of cross-functional teams and the Global Project Team, partnering with Program Leadership, Translational Medicine, Biostatistics, Clinical Pharmacology, Regulatory Affairs, Clinical Operations, Safety and Medical Writing
• Support study design, dose strategy and indication prioritization
• Provide medical monitoring and clinical oversight for assigned studies
• Review and interpret safety and efficacy data to support study decisions
• Author and contribute to key clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, briefing books, submission documents and dossiers
• Support interactions with Health Authorities and internal governance bodies
• Drive delivery of milestones across global teams and timelines
• Contribute to a high-performing, collaborative matrix environment

Minimum Qualifications

• MD with expertise in clinical drug development and required expertise in oncology
• 3+ years of industry experience in clinical R&D within pharma or biotech
• Experience supporting or leading clinical studies across Phase 1 to Phase III
• Experience contributing to clinical development strategy, regulatory submissions and registration-enabling activities
• Familiarity with clinical dossiers, regulatory documentation and Health Authority interactions
• Demonstrated ability to integrate translational and biomarker data into development decisions
• Experience working in cross-functional, matrixed, international teams
• Familiarity with ICH-GCP, FDA and/or EMA expectations and clinical trial regulations
• Strong written and verbal communication skills in English
• Ability to work independently, manage multiple priorities and collaborate across time zones in an office-based environment

Preferred Qualifications

• Experience in targeted therapies, ADCs, immuno-oncology and/or hematology/hematologic oncology
• Experience across early and late clinical development
• Experience contributing to study designs that support potential registration pathways
• Experience in precision medicine and/or biomarker-driven development
• Strong project leadership, with a track record of driving timelines and decision points
• Board certification in Medical Oncology/Hematology or a relevant subspecialty