Clinical Science Lead
Takeda
Summary
In this Director level role, you will help shape the scientific and operational strategy for clinical studies across a diverse evidence generation portfolio. You will play a key role in advancing Phase 3B and Phase 4 interventional and non-interventional studies, real-world evidence initiatives, collaborative research, and investigator-initiated activities. Working across functions, you will help ensure studies are scientifically robust, operationally feasible, and delivered with a strong focus on quality, compliance, and business priorities.
Job description
About the Role
In this Director level role, you will help shape the scientific and operational strategy for clinical studies across a diverse evidence generation portfolio. You will play a key role in advancing Phase 3B and Phase 4 interventional and non-interventional studies, real-world evidence initiatives, collaborative research, and investigator-initiated activities. Working across functions, you will help ensure studies are scientifically robust, operationally feasible, and delivered with a strong focus on quality, compliance, and business priorities.
How You Will Contribute
- Provide scientific and operational leadership for the planning, implementation, oversight, execution, and reporting of clinical, real-world evidence, and externally sponsored studies.
- Lead study design and document development through the creation, review, and approval of protocols, amendments, study concepts, and related materials.
- Ensure study quality and feasibility by aligning study designs and execution plans with evidence generation priorities and stakeholder needs.
- Manage study delivery and performance by overseeing timelines, enrollment, budgets, operational metrics, risks, and quality indicators.
- Interpret and communicate clinical findings by translating complex clinical and safety data into recommendations, reports, publications, and decision-support materials.
- Partner across functional teams to support compliant study governance, vendor oversight, contracting, reporting, and archiving activities.
- Lead vendor and external partnership management while maintaining budget stewardship across the assigned portfolio.
- Drive continuous improvement and innovation through the adoption of digital and artificial intelligence-enabled tools that enhance evidence generation and study management.
Qualifications
- Advanced degree in a scientific, clinical, epidemiologic, quantitative, or health-related discipline.
- 10+ years of experience in clinical development, evidence generation, clinical research, or related disciplines involving interventional and non-interventional studies.
- Significant experience in clinical science, clinical development, study implementation, epidemiology, real-world evidence, or related biopharmaceutical functions.
- Strong experience authoring, reviewing, and approving clinical trial protocols and related study documentation.
- Experience leading global or multi-country clinical studies through implementation and publication.
- Extensive knowledge of interventional and non-interventional study designs, good clinical practice, applicable regulations, ethics, quality standards, and standard operating procedure-driven practices.
- Demonstrated ability to interpret complex clinical and safety data and communicate findings effectively to diverse audiences.
- Strong program leadership, stakeholder management, vendor oversight, decision-making, and team leadership skills, including experience using digital and artificial intelligence-enabled tools in a regulated environment.
Requirements
- Advanced degree in a scientific, clinical, epidemiologic, quantitative, or health-related discipline
- 10+ years of experience in clinical development, evidence generation, clinical research, or related disciplines involving interventional and non-interventional studies
- Significant experience in clinical science, clinical development, study implementation, epidemiology, real-world evidence, or related biopharmaceutical functions
- Strong experience authoring, reviewing, and approving clinical trial protocols and related study documentation
- Experience leading global or multi-country clinical studies through implementation and publication
- Extensive knowledge of interventional and non-interventional study designs, good clinical practice, applicable regulations, ethics, quality standards, and standard operating procedure-driven practices
- Demonstrated ability to interpret complex clinical and safety data and communicate findings effectively to diverse audiences
- Strong program leadership, stakeholder management, vendor oversight, decision-making, and team leadership skills, including experience using digital and artificial intelligence-enabled tools in a regulated environment
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.