Senior Director, DMPK&M, Therapeutic Area Lead - GI2
Takeda
Summary
Technical Expertise: Comprehensive understanding of drug discovery and development, the pharmaceutical industry, and DMPK&M science.
Job description
Objectives/Purpose
- Provide strong scientific and strategic leadership impacting the pipeline, talent, and strategy for the Gastrointestinal & Inflammation (GI2) therapeutic area in DMPK&M.
- Supervise and lead a team of DMPK&M project representatives and Modeling & Simulation (M&S) scientists delivering on Takeda's research pipeline in GI2.
- Oversee the DMPK&M strategy of the GI2 portfolio and ensure execution of DMPK&M project plans, translation, and dose optimization strategies, as well as review of regulatory filings.
- Participate in therapeutic area-driven discussions and partner with cross-functional stakeholders to align on Takeda's strategic framework.
- Serve as a key member of the Global DMPK&M leadership team driving department strategy, culture, and partnerships across Research and Development.
Scope
- Lead a team of DMPK project representatives and modeling scientists with key scientific and strategic input to research projects.
- Accountable for strategic planning and scientific oversight of the discovery and development portfolio for the GI2 therapeutic area.
- Actively support the DMPK&M Head in strategic execution of the DMPK&M Vision and Mission.
- Drive development of organizational culture and capabilities by building alliances across Research and Development.
Scientific Responsibilities
- Provide scientific leadership and strategic guidance on stage-appropriate DMPK&M questions to ensure selection and development of clinical candidates with optimal drug development characteristics.
- Build and enhance an external network to monitor scientific developments, novel strategies, partnership opportunities, and the competitive and regulatory landscape, particularly in GI2 therapeutic areas.
- Advise, review, and approve milestone presentations and PRC narratives on behalf of DMPK&M.
- Oversee and participate in regulatory activities, including review and approval of robust, fit-for-purpose submission packages in the GI2 therapeutic area.
Strategic Responsibilities
- Act as the DMPK&M functional representative in governance committees and discussions regarding prioritization, strategy, resources, timelines, and decision-making criteria.
- Facilitate alignment of DMPK&M strategy with DDU and TAU portfolio goals.
- Collaborate with DDU and TAU senior leaders, communicating needs, strategy, and execution plans while consulting with DMPK leadership to ensure resources and goals are aligned.
- Accountable for appropriate resourcing of project support by collaborating with the Global DMPK&M leadership team.
- Resource and review in-licensing evaluations for the respective therapeutic area.
Dimensions and Aspects
Technical Expertise: Comprehensive understanding of drug discovery and development, the pharmaceutical industry, and DMPK&M science.
Leadership: Ability to work across functions, regions, and cultures; functional-level leadership with the ability to inspire, motivate, and drive results; excellent communicator who can persuasively convey ideas and data verbally and in writing; proven team player who engenders credibility and confidence; ability to distill complex issues into simple terms; demonstrates leadership presence and confidence; embraces diversity and inclusion; builds teams across functions and geographies; invests in developing others.
Decision-making and Autonomy: Provides input to highly complex decisions impacting the functional area; accountable for decision making for the designated function; seeks diverse input from multiple constituents and stakeholders; incorporates feedback and ensures swift implementation; accountable for providing input to and implementing vision and strategy for designated scope.
Interaction: Effectively navigates changing external and internal environments and leads others through change; cultivates a broad network of relationships throughout Takeda, with affiliates and external partners; effectively represents the function in negotiations and resolves conflict constructively; builds strong relationships and collaborates with other interfacing Takeda functions.
Innovation: Forward thinking with the ability to recommend, influence on behalf of DMPK&M, and implement continuous innovation; comfortable challenging the status quo; ability to take risks implementing innovative solutions to accelerate time to market.
Complexity: Ability to work in a global ecosystem (internal and external) with a high degree of complexity; ability to see and understand a broader, enterprise-level perspective.
Requirements
- PhD degree in a scientific discipline with 15+ years experience, MS with 21+ years experience, or BS with 23+ years experience
- At least 9 years of industry experience in pharmaceutical DMPK and modeling
- Good understanding of the GI2 DDU/TAU project portfolio, disease indications, and typical DMPK&M considerations for patients
- Deep drug discovery and development experience and profound DMPK&M expertise required
- Experience in managing preclinical scientists and preparation of INDs, CTDs, NDAs, and MAAs
- Proactive, innovative, with good problem-solving skills
- Exceptional leadership, coaching, and employee development skills
- Ability to work strategically in a cross-functional team and matrix environment
- In-depth knowledge of the functional area, business strategies, and company goals
- Excellent written, presentation, and verbal communication skills
- A track record of sustained, significant scientific contributions in DMPK and modeling, as demonstrated by publications and presentations
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Base Salary Range $212,000 - $333,190
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.