Senior Director, DMPK&M, Therapeutic Area Lead - GI2

Takeda•Boston, MA

4d•$212,000 - $333,190

About The Position

The Gastrointestinal & Inflammation (GI2) Therapeutic Area Lead in DMPK&M provides scientific and strategic leadership across the pipeline, talent, and strategy. The role supervises DMPK&M project representatives and Modeling & Simulation (M&S) scientists who support Takeda’s GI2 research pipeline. It oversees DMPK&M strategy for the GI2 portfolio, execution of project plans, translation and dose optimization strategies, and review of regulatory filings. The role contributes to therapeutic-area discussions and partners with cross-functional stakeholders to align with Takeda’s strategic framework. As a member of the Global DMPK&M leadership team, it contributes to portfolio strategy and global business operations, helps shape department strategy and culture, and strengthens partnerships across Research and Development. The position provides scientific guidance on stage-appropriate DMPK&M questions to support selection and development of clinical candidates with optimal drug-development characteristics. It builds external scientific networks, advises on and approves milestone presentations and PRC narratives, and oversees regulatory activities, including review and approval of fit-for-purpose submission packages for GI2. It represents DMPK&M in governance discussions, aligns functional strategy with DDU and TAU portfolio goals, collaborates with senior leaders on needs and execution plans, supports project resourcing, and reviews in-licensing evaluations for the therapeutic area.

Requirements

PhD in a scientific discipline with 15 or more years of experience; or MS with 21 or more years of experience; or BS with 23 or more years of experience.
At least 9 years of industry experience in pharmaceutical DMPK and modeling.
Deep drug discovery and development experience and profound DMPK&M expertise.
Experience managing preclinical scientists and preparing INDs, CTDs, NDAs, and MAAs.
Understanding of the GI2 DDU/TAU project portfolio, disease indications, and typical DMPK&M considerations for patients.
Proactive, innovative, and able to solve problems effectively.
Exceptional leadership, coaching, and employee development skills.
Ability to work strategically in cross-functional teams and a matrix environment.
In-depth knowledge of the functional area, business strategies, and company goals.
Excellent written, presentation, and verbal communication skills.
Track record of sustained, significant scientific contributions in DMPK and modeling, demonstrated through publications and presentations.
Ability to work across functions, regions, and cultures and to build effective relationships with internal and external partners.
Ability to communicate complex issues clearly, make decisions using diverse stakeholder input, and drive implementation.

Responsibilities

Lead and supervise DMPK project representatives and Modeling & Simulation scientists supporting the GI2 research portfolio.
Oversee DMPK&M strategy and scientific planning for the GI2 discovery and development portfolio.
Ensure execution of DMPK&M project plans, translation and dose optimization strategies, and review of regulatory filings.
Provide scientific leadership and strategic guidance on DMPK&M questions to support selection and development of clinical candidates.
Build external networks to monitor scientific developments, novel strategies, partnership opportunities, and competitive and regulatory landscapes relevant to GI2.
Advise on, review, and approve milestone presentations and PRC narratives; oversee and participate in regulatory activities and review and approve submission packages.
Represent DMPK&M in governance committees and discussions concerning prioritization, strategy, resources, timelines, and decision-making criteria.
Align DMPK&M strategy with DDU and TAU portfolio goals and collaborate with senior leaders on needs, strategy, and execution plans.
Work with the Global DMPK&M leadership team to appropriately resource project support.
Review in-licensing evaluations for the GI2 therapeutic area.
Support execution of the DMPK&M vision and mission, contribute to department strategy and culture, and build alliances across Research and Development.
Coach and develop employees, build cross-functional and geographically distributed teams, and lead others through change.