Jobs · Healthcare · Massachusetts

Medical Director, Global Clinical Development, Oncology

Physician Pivot · Boston, MA · 2 wk ago
HealthcareFull-time
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 interactionsIntegrate clinical, translational, biomarker and emerging data to support indication strategy, patient selection, dose strategy and key development decisionsAct 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 WritingSupport study design, dose strategy and indication prioritizationProvide medical monitoring and clinical oversight for assigned studiesReview and interpret safety and efficacy data to support study decisionsAuthor and contribute to key clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, briefing books, submission documents and dossiersSupport interactions with Health Authorities and internal governance bodiesDrive delivery of milestones across global teams and timelinesContribute to a high-performing, collaborative matrix environment Minimum Qualifications MD with expertise in clinical drug development and required expertise in oncology3+ years of industry experience in clinical R&D within pharma or biotechExperience supporting or leading clinical studies across Phase 1 to Phase IIIExperience contributing to clinical development strategy, regulatory submissions and registration-enabling activitiesFamiliarity with clinical dossiers, regulatory documentation and Health Authority interactionsDemonstrated ability to integrate translational and biomarker data into development decisionsExperience working in cross-functional, matrixed, international teamsFamiliarity with ICH-GCP, FDA and/or EMA expectations and clinical trial regulationsStrong written and verbal communication skills in EnglishAbility 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 oncologyExperience across early and late clinical developmentExperience contributing to study designs that support potential registration pathwaysExperience in precision medicine and/or biomarker-driven developmentStrong project leadership, with a track record of driving timelines and decision pointsBoard certification in Medical Oncology/Hematology or a relevant subspecialty

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