Job Description

The Medical Director, Clinical Science - Thoracic Oncology provides medical and scientific leadership for the design, execution and interpretation of global clinical studies within Takeda's thoracic oncology portfolio, spanning non-small cell lung cancer, small cell lung cancer and other intrathoracic malignancies.

Reporting to the Executive Medical Director, Oncology Clinical Sciences, the role partners with the Clinical Development lead to translating program strategy into high-quality protocols, robust data and regulatory-grade deliverables that advance assets from first-in-human through registrational studies and lifecycle expansion.

The role is a core contributor to the clinical evidence that underpins health authority interactions (FDA, internal governance reviews and serves as a credible scientific voice with investigators and external experts in the thoracic oncology community.

Scope

• Supports one or more global thoracic oncology assets and their associated Phase 1-3 studies; scope of studies assigned scales with demonstrated capability.
• Geographic: Global - studies conducted across North America, Europe, Japan and Asia-Pacific, including partnered and alliance-run trials.
• People: Individual contributors. lead through influence within global study teams and may mentor junior clinical scientists and physicians.
• Financial: Contributes to study budget planning and vendor oversight in partnership with Clinical Operations and Program Management; no independent budget accountability.

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.

Education, Experience and Skills

Required

• MD/PhD , M.D. or D.O. (or international equivalent) with completion of residency; board eligibility or certification in Medical Oncology, Hematology/Oncology or Internal Medicine plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related company, or biomedical/clinical experience within academia (or a combination of afore mentioned) strongly preferred.
• Direct clinical trial experience in oncology - industry, academic or a combination - with demonstrated protocol development and study conduct exposure.
• Working knowledge of ICH-GCP, regulatory requirements for oncology drug development, and the global clinical trial environment.
• Familiarity with oncology response and safety frameworks (e.g., RECIST 1.1, CTCAE) and with standard efficacy endpoints (ORR, PFS, OS, DoR).
• Strong written and verbal scientific communication; able to present complex data clearly to cross-functional and senior audiences.
• Demonstrated ability to work effectively in a global matrix and to manage competing priorities.

Preferred

• 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.

Travel Requirements

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

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Boston, MA

U.S. Base Salary Range:
$237,200.00 - $372,790.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

Locations
Boston, MA

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.