Therapeutic Area Lead, DMPK & Modeling (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.

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.
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.
Actively attract, develop, and retain talent.

Benefits

U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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