Senior Director, Drug Metabolism and Pharmacokinetics

4 days ago

Boston, Massachusetts, United States Takeda Pharmaceutical Full time
Job Description

At Takeda Pharmaceutical, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. Our team is dedicated to pushing the boundaries of what is possible in order to bring life-changing treatments to patients worldwide.

Key Responsibilities
  • Represent the GI2 (Inflammation & Immunology) DDU, TAU, and GI2 project portfolio as an engaged member of the DMPK&M Leadership Team.
  • Regularly participate in DMPK LT meetings to provide updates on therapeutic area status, critical issues, and major milestones.
  • Develop and execute DMPK strategy for all GI2 DDU and TAU projects in partnership with DMPK&M leads.
  • Run and maintain regular operational/strategy meetings of all DMPK staff involved in supporting GI2 portfolio.
  • Ensure study protocol reviews support DMPK Project Team Representatives in experimental design and data interpretation.
  • Review study reports and regulatory documents for scientific accuracy and consistency of human risk assessment message.
  • Provide continuous mentorship and performance feedback to DMPK Project Team Representatives.
  • Frequently interact with Global Head, DMPK partnership leads, fellow DMPK&M SPOCs, and Heads of DMPK&M Sub-Discipline Functions to address questions on strategy and anticipate and resolve potential issues.
Accountabilities
  • Provide strategic leadership across GI2 (Inflammation & Immunology) DDU and TAU, representing DMPK, and making strategic decisions in consultation with senior leaders to advance research projects from target selection to clinical submission.
  • Ensure selection of clinical candidates with optimal drug development characteristics and appropriate characterization and development of these candidates.
  • Provide scientific and strategic guidance on stage-appropriate questions related to drug metabolism, bioanalysis, quantitative biomarkers, PK, and PK/PD.
  • Guide efficient design and execution of studies in support of drug candidates.
  • Oversee GI2 project portfolio as the DMPK Leadership Team nominee, ensuring that the DMPK strategy is in alignment with other functions in discovery and development.
  • Interact directly with DDU and TAU head (or designee) to determine goals, strategy, and execution of the development of drug candidates.
  • Participate in DDU and TAU leadership discussions and decision-making.
  • Provide scientific and strategic expertise to DMPK Project Team Representatives for the development of TA drug candidates.
  • Review and advise on data, reports, scientific conclusions, and presentations.
  • Approve DMPK components of drug strategy for all GI2 projects at appropriate milestones and review and approve the appropriate sections of internal project documentation.
  • Stay informed on the latest trends in the competitive and regulatory landscape, particularly as it relates to specific therapeutic areas.
  • Align goals and resources with DDU and TAU and communicate those needs to DMPK Head and other DMPK functional leaders as needed.
Requirements
  • PhD with 15+ years' industry experience or equivalent (MS with 21+ years' experience, or BS with 23+ years' experience).
  • Good understanding of the GI2 (Inflammation & Immunology DDU/TAU project portfolio, disease indications, and typical DMPK considerations for patients.
  • Experience working with multiple modalities, ideally small molecules, ASOs, gene therapy, cell therapy, and biologics.
  • Experience in all stages of drug development from discovery to marketed product support.
  • Experience making recommendations to senior management of other line functions regarding key program decisions.
  • Experience in regulatory submission (INDs, CTA, NDAs, MAAs) and in health authority (FDA, EMA, PMDA) interactions, and experience in developing strategies around those interfaces in collaboration with the Regulatory function.
Benefits

Takeda offers a competitive compensation package, including a base salary range of $205,000 to $322,300, as well as opportunities for short-term and long-term incentives, 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.

Takeda is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics protected by law.

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