Director, Pharmacometrics
About The Position
Takeda’s Pharmacometrics team is part of the Data and Quantitative Sciences (DQS) group and works across therapeutic areas with Quantitative Clinical Pharmacology (QCP) leads to develop and execute Model-Informed Drug Development (MIDD) strategies. The Director leads and is accountable for asset-level pharmacometrics strategies and supports portfolio decisions, infrastructure, and best-practice initiatives. The role is expected to be an established expert in a specific pharmacometrics methodology or field and to build productive relationships with experts in digital health, global outcomes and epidemiology, biostatistics, and other data science disciplines. The position represents Pharmacometrics, QCP, and DQS within R&D and the external scientific community through scientific meeting participation and publications. It leads asset-level analyses and strategies, supports regulatory interactions and submissions, contributes to cross-functional decisions and development plans, and mentors colleagues. The role is based in Cambridge, Massachusetts.
Requirements
- PharmD or PhD and 8 or more years of work experience in a quantitative field, with experience in pharmacometrics, mechanistic modeling, statistics, or chemical bio-engineering; alternatively, an MS and 12 or more years of such experience.
- Established pharmacometrician and recognized domain expert in a particular methodology or area, such as safety and its application to drug development.
- Expertise in relevant software, such as R, NonMem, Stan, SAS, or Phoenix.
- Experience leading and driving the scoping and implementation of MIDD within projects and at an asset or platform level.
- Hands-on expertise or knowledge applying advanced integration of multiple data sources, including PK/PD, efficacy, safety, biomarkers, RWE, and RWD, to support dose selection, optimized trial design, and quantitative decision-making.
- Solid mathematical and/or statistics background.
- Strong knowledge of allied fields critical to drug development, such as statistics or clinical pharmacology.
- Ability to evaluate benefit-risk associated with project decisions, manage GPT expectations, and influence therapeutic area strategies.
- Leadership in cross-functional decisions to optimize drug R&D success and use of the quantitative decision-making framework.
- Ability to drive efficiency through innovative processes and methodologies.
- Consistently deliver high-quality work efficiently and fulfill commitments.
- Communicate effectively and influence cross-functional teams; inspire commitment and enable collaboration.
- Focus on priorities and deliver on commitments.
Responsibilities
- Define, lead, and drive asset-level pharmacometrics strategies that support asset advancement and decision-making milestones, influencing project and clinical teams.
- Lead and advance in-house modeling capabilities, including c-QTc analysis automation, MBMA, clinical trial simulation, and mechanistic modeling.
- Drive pharmacometrics strategies and MIDD as part of the overall QDM framework, integrating the pharmacometrics plan in collaboration with QCP and SQS.
- Represent Pharmacometrics in global or regional regulatory agency meetings when required, and take responsibility for the technical component of clinical pharmacology summary documents for regulatory submissions.
- Oversee and/or independently perform PK, PD, and pharmacometric analyses, including interpretation of PK/PD data in partnership with DSI and external partners.
- Maintain high standards for good clinical practice, compliance, and ethics.
- Mentor junior staff, act as a cross-functional leader, and potentially manage a sub-team within a therapeutic area.
- Participate in Business Development due diligence when requested.
- Lead infrastructure and/or cross-functional best-practice initiatives.
- Demonstrate leadership in scientific societies and cross-industry consortiums related to pharmacometrics work streams.
- Represent Pharmacometrics, QCP, and DQS to the R&D organization and external scientific community through high-value participation at scientific meetings and impactful publications.
- Lead and execute pharmacometrics strategies independently for multiple projects at the asset level or across therapeutic areas.
- Communicate success stories and share learning across QCP and Pharmacometrics; elevate others’ knowledge and capability.
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What This Job Offers
Job Type
Full-time
Career Level
Director
