Medical Director, Clinical Science – Thoracic Oncologyence

Medical Director, Clinical Science – Thoracic Oncology

Role & Responsibilities

• Provide medical and scientific leadership for design, execution, and interpretation of global clinical studies in thoracic oncology (NSCLC, SCLC, and other intrathoracic malignancies).
• Partner with Clinical Development to translate program strategy into high-quality protocols, robust data, and regulatory-grade deliverables (first-in-human through registrational and lifecycle expansion).
• Contribute to clinical development plan/strategy, dose selection/optimization, biomarker and patient-selection strategies (e.g., histology, PD-L1), and study design implications.
• Author/co-author protocols, amendments, informed consent templates, investigator brochures, and clinical study reports.
• Serve as medical monitor/deputy medical monitor (eligibility adjudication, deviation review, dose-modification guidance, site medical support).
• Partner with Clinical Operations/CROs on feasibility, site selection, enrollment strategy, and risk mitigation; support ongoing safety/efficacy review and data review/interpretation.
• Prepare/support committee materials (IDMC, Dose Escalation, Safety Management); partner with Pharmacovigilance on safety review and benefit-risk.
• Support IND/CTA content, briefing books, health authority responses, marketing applications, and health authority interactions.

Required Qualifications

• MD/PhD, MD, or DO (or international equivalent) with completed residency; board eligibility/certification in Medical Oncology, Hematology/Oncology, or Internal Medicine; 5+ years clinical research experience (industry/CRO/academia strongly preferred).
• Direct oncology clinical trial experience with protocol development and study conduct exposure.
• Working knowledge of ICH-GCP, oncology regulatory requirements, and global clinical trial environment.
• Familiarity with RECIST 1.1, CTCAE, and endpoints (ORR, PFS, OS, DoR).
• Strong written/verbal scientific communication; global matrix effectiveness.

Preferred Qualifications

• Thoracic malignancy focus (NSCLC/SCLC); immuno-oncology/antibody modality experience (irAE management); health authority interaction and registrational design exposure; alliance/partnered program experience; peer-reviewed publications.

Travel

• Willingness to travel internationally to investigator meetings, congresses, partner sites, and Takeda locations.