Medical Director, Clinical Science – Thoracic Oncologyence
Takeda
August 29, 2026
Remote friendly (Boston, MA)
United States
$237,200 - $372,790 USD yearly
Clinical Research and Development
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.
Benefits/Compensation/Application Instructions
- Not included (no explicit application instructions or benefits details provided in the job description text excerpt).
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.
Benefits/Compensation/Application Instructions
- Not included (no explicit application instructions or benefits details provided in the job description text excerpt).