Medical Director, Clinical Science – Thoracic Oncology

Accountabilities

• Contribute medical and scientific input to the clinical development plan and strategy for assigned thoracic oncology study.
• Support dose selection and optimization strategy consistent with FDA Project Optimus expectations, working with Clinical Pharmacology, Translational Medicine, and Biostatistics.
• Provide clinical input into biomarker and patient-selection strategies, including histology and PD‑L1‑based subgroup considerations, and into stratification and multiplicity assumptions.
• Maintain current competitive and scientific landscape intelligence for thoracic tumors and translate it into implications for study design and timing.
• Author or co-author with clinical study protocols, amendments, informed consent templates, investigator brochures and clinical study reports.
• Serve as a medical monitor or deputy medical monitor: eligibility adjudication, protocol deviation review, dose-modification guidance and site medical support.
• Partner with Clinical Operations and CROs on feasibility, site selection, enrollment strategy and risk mitigation to protect study timelines and data quality.
• Contribute to data review activities, including ongoing safety and efficacy review, data cleaning, database lock readiness, and interpretation of study results.
• Prepare materials for and support Independent Data Monitoring Committee, Dose Escalation Committee and Safety Management Team meetings.
• Partner with Pharmacovigilance on individual case review, signal evaluation, aggregate safety reporting and benefit‑risk assessment for assigned studies.
• Ensure risk-management measures, including immune‑related and infusion‑related toxicity guidance, are appropriately reflected in protocols and study documents.
• Contribute clinical content to IND/CTA submissions, briefing books, health authority responses and marketing applications.
• Support preparation for and participation in health authority interactions, including End‑of‑Phase 2 and pre‑submission meetings.
• Prepare clinical sections of internal governance materials for portfolio, research and clinical review boards, and present study‑level content as delegated.
• Build and maintain relationships with investigators and external experts in thoracic oncology; support advisory boards, investigator meetings and site engagement.
• Contribute to abstracts, manuscripts, congress presentations and other scientific disclosures in line with publication policy.
• Represent Clinical Science in alliance and partnership interactions, supporting joint development discussions and data-sharing activities.
• Execute all activities in full compliance with ICH‑GCP, applicable regulations, Takeda policies, SOPs and ethical standards, with patient safety and data integrity as non-negotiable priorities.
• Solid working knowledge of thoracic oncology (NSCLC, SCLC, mesothelioma, thymic malignancies) and of immuno-oncology, antibody-based and targeted modalities. GCP, ICH and protocol design principles apply to author and execute clinical study documents with limited supervision.
• Leads defined workstreams within the global study team and influence across a matrix. Role-models Takeda’s culture pillars – Patient-Centric, People-Minded, Respectful & Collaborative, Decision Effectiveness, Performance Culture and Enterprise Orientation.
• Operates with moderate autonomy on study-level decisions; escalates program-level and strategic decisions to the Clinical Development Lead. Applies clear decision roles (Decide / Advise / Inform), balancing patient safety, data integrity, trust, reputation and business priorities.
• Partners internally with Biostatistics, Clinical Pharmacology, Translational Medicine, Regulatory Affairs, Pharmacovigilance, Clinical Operations, Value & Access and Program Management. Engages externally with investigators, external experts, CROs, alliance partners and, with supervision, health authorities.
• Contributes to innovative trial design, dose optimization and biomarker-enrichment strategies. Applies data and digital tools to accelerate learning and improve trial quality and efficiency.
• Supports global, multi-regional studies across the US, EU, Japan and China, navigating divergent regulatory expectations, standard-of-care differences and evolving competitive dynamics in first line and relapsed/refractory thoracic tumors.
• Sets ambitious, measurable objectives; acts with speed and accountability to deliver study milestones on time and with quality.
• Collaborates across functions and geographies, shares best practices and prioritizes enterprise outcomes over local preferences.

Preferrednice to have

• Prior clinical or research focuses on thoracic malignancies, particularly NSCLC and SCLC.
• Experience immuno‐oncology or antibody‑based modalities, including immune‑related adverse event management.
• Exposure to health authority interactions (FDA, EMA, PMDA or NMPA) and registrational study design.
• Experience supporting partnered or alliance‑managed programs across regions.
• Peer‑reviewed publication record in thoracic oncology or related solid tumor research.

• Willingness to travel to investigator meetings, scientific congresses, partner sites and Takeda locations, including international travel.