Therapeutic Area Lead (TAL), Drug Metabolism, Pharmacokinetics and Modeling (DMPK&M) (Sr. Director)

Takeda•Boston, MA

About The Position

The Therapeutic Area Lead in DMPK&M will have strong scientific and strategic leadership to impact broad responsibilities on the pipeline, talent, and strategy. This role will supervise and lead a team of DMPK&M project representatives and Modeling & Simulation (M&S) scientists responsible for delivering on Takeda’s research pipeline in NS, GI2, or ONC therapeutic area. This role is responsible for oversight on the DMPK&M strategy of the respective portfolio and ensures the execution of DMPK&M project plans, translation, and dose optimization strategies, as well as review of regulatory filings. This role will participate in therapeutic area-driven discussions and partner with cross-functional stakeholders to align on Takeda’s strategic framework. Key deliverables will be contributing to portfolio strategy and global business operations within DMPK&M. Demonstrates leadership experience in guiding talented teams and is a key member of the Global DMPK&M leadership team that drives department strategy, creates a positive and effective department culture, and strengthens partnerships across the Research and Development organizations within Takeda. Scope: Leads a team of DMPK project representatives and modeling scientists who have key scientific and strategic input to research projects to enable Takeda to meet its global research goals. Accountable for strategic planning and scientific oversight of the discovery and development portfolio for their respective therapeutic area. Actively supports DMPK&M Head in strategic execution of DMPK&M Vision and Mission. Drives the development of organizational culture and capabilities by building strong alliances across the Research and Development organizations within Takeda. Scientific responsibilities: Provides scientific leadership and strategic guidance on stage-appropriate questions related to DMPK&M to ensure the selection and development of clinical candidates with optimal drug development characteristics. Builds and enhances an external network to keep a pulse on scientific developments, novel strategies, partnership opportunities, and the latest competitive and regulatory landscape, particularly in relation to specific therapeutic areas. Advises, reviews, and approves, on behalf of DMPK&M, milestone presentations and PRC narratives. Oversees and participates in regulatory activities, including the review and approval of robust and fit-for-purpose submission packages in their respective areas. Strategic responsibilities: Act as the DMPK&M functional representative in governance committees and discussions regarding prioritization, strategy, resources, timelines, and decision-making criteria. As the DMPK&M Therapeutic Area Lead, this role will facilitate the 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. Resources and reviews in-licensing evaluations for their respective therapeutic area. Management responsibilities: Actively attract, develop, and retain talent. Dimensions and Aspects: Technical/Functional (Line) Expertise: Comprehensive understanding of drug discovery and development, the pharmaceutical industry, DMPK&M science. Leadership: Achieves success for Takeda by collaboratively working with partners across the organization. Ability to work across functions, regions, and cultures. Functional level leadership with the ability to inspire, motivate and drive results. Excellent communicator can persuasively convey both ideas and data, verbally and in writing. Proven skills as an effective team player who can engender credibility and confidence within and outside the company. Ability to distill complex issues and ideas down to simple comprehensible terms. Demonstrates leadership presence and confidence. Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization. Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level.

Requirements

Good understanding of the (NS, GI2 or ONC) 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, 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 the company’s 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.
PhD degree in a scientific discipline with 15+ years experience, MS with 21+ years experience, or BS with 23+ years experience including at least 9 years of Industry experience in pharmaceutical DMPK and modeling

Responsibilities

Provides scientific leadership and strategic guidance on stage-appropriate questions related to DMPK&M to ensure the selection and development of clinical candidates with optimal drug development characteristics.
Builds and enhances an external network to keep a pulse on scientific developments, novel strategies, partnership opportunities, and the latest competitive and regulatory landscape, particularly in relation to specific therapeutic areas.
Advises, reviews, and approves, on behalf of DMPK&M, milestone presentations and PRC narratives.
Oversees and participates in regulatory activities, including the review and approval of robust and fit-for-purpose submission packages in their respective areas.
Act as the DMPK&M functional representative in governance committees and discussions regarding prioritization, strategy, resources, timelines, and decision-making criteria.
Facilitate the 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.
Resources and reviews in-licensing evaluations for their respective therapeutic area.
Actively attract, develop, and retain talent.