Executive Director, Pharmacometrics Head
Job Description
Takeda is a global, values‑based, R&D‑driven, top‑10 biopharmaceutical leader committed to discovering and delivering life‑transforming treatments, guided by our commitment to patients, people, and the planet.
Objective / Purpose Our Data and Quantitative Sciences Department (DQS) comprises more than 700 quantitative scientists who harness data to accelerate the development of highly innovative treatments. The Pharmacometrics team, part of DQS and Quantitative Pharmacology and Translational Science (QPTS), drives, implements, and executes a model‑informed drug development (MIDD) strategy for each asset from pre‑FIH through life‑cycle management within the global project team.
Position Objectives
Strategically lead and implement model‑informed drug development strategies across early and late‑phase clinical portfolios, enabling robust dose/regimen recommendations, trial designs, and go‑no‑go decisions through the life‑cycle of our products in collaboration with other functions (e.g., QCP, SQS, GEO).
Drive the implementation of automation and AI in pharmacometrics (E2E) to increase capacity, quality, and timeline efficiencies, continuously advancing the field and enabling data‑ and model‑based decision making across all phases of drug development.
Serve as a recognized expert internally and externally in mechanistic modelling and traditional pharmacometrics, demonstrating experience optimizing clinical drug development and applying MIDD principles to emerging data sources (RWD, natural history registries, omics data, HER data, etc.).
Explore and excel in synergistic relationships with experts in statistics and other data science disciplines, driving an integrated approach.
Provide portfolio support through program reviews, collaborative decision making, and best‑practice initiatives, including evaluating probability of technical success and business development opportunities.
Act as an ambassador of Pharmacometrics, Quantitative Clinical Pharmacology (QCP), QPTS, and DQS to the R&D organization and the external scientific community through scientific meetings and impactful publications.
Accountabilities
Lead and manage a team of in‑house pharmacometricians to deliver all analyses internally and externally supporting the Takeda clinical portfolio and business development activities.
Maintain relationships with external vendors to support regulatory pharmacometrics analyses.
Operate at an enterprise level, defining, leading, and driving cross‑therapeutic area and platform‑level pharmacometrics strategies that advance the Takeda portfolio through decision‑making milestones, including product valuation and reimbursement.
Lead the evolution of our in‑house modelling platform, envisioning increased automation, integration of emerging data sources, and AI with an end‑to‑end mindset, complying with GxP.
Collaborate with DMPK&M to transition and implement mechanistic modelling and thinking (PK‑PD, PBPK‑PD, QSP) into the clinical portfolio as assets progress through IND, enriching understanding and informing opportunities, populations, dosing, and trial design.
Drive pharmacometrics strategies, including MIDD, as part of the overall QDM framework, coordinating with QCP and SQS.
Represent Pharmacometrics in regulatory agency meetings and produce the technical components of clinical pharmacology summary documents for regulatory submissions.
Maintain high standards for good clinical practice, compliance, and ethics.
Participate in business development due diligence, providing evidence‑based risk assessments.
Promote and advance the Pharmacometrics vision and mission, creating delivery for the DQS mission to impact R&D business.
Serve as a role model for QCP and DQS members and act as a cross‑functional collaborative leader.
Demonstrate leadership in scientific societies and cross‑industry consortiums related to pharmacometrics (ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, DIA).
Education & Competencies (Technical And Behavioral)
Pharm D or PhD with 15+ years of quantitative experience, including extensive pharmacometrics, mechanistic modelling, statistics, or chemical bio‑engineering, plus strong management and leadership experience.
MS with 18+ years of quantitative experience, similar breadth and depth, and proven leadership.
Desired Technical Skills
Subject‑matter expert in multiple areas with leadership of internal or external focus groups.
Robust understanding of pharmacology and statistical principles.
Recognized expert in pharmacometrics and clinical pharmacology, passionate about AI and automation.
Define and lead cross‑therapeutic strategy, directing complex pharmacometrics analyses and developing innovative methodologies in partnership with other DQS functions.
Influence business‑critical decision making beyond QCP/Pharmacometrics responsibilities.
Strong mathematical and pharmacological/mechanistic training.
Experienced drug developer with full‑cycle R&D cross‑functional strategy understanding.
Extensive experience in HA interactions and submissions.
Implement MIDD strategies within global filings and approvals.
Optimize trial design, sample size, and assessment timelines using innovative processes and methodologies.
Evaluate benefit‑risk for projects, assets, and TAU decisions, managing expectations.
Establish external networks for collaboration across industry, government, and academia.
Desired Behavioral Competencies
Strong scientific and strategic leadership.
People management and leadership experience.
Excellent organizational skills for process and resources.
Effective communication with stakeholders and audiences.
Mobilize high‑performance teams.
Influence beyond QPTS and DQS.
Negotiation and conflict management in matrix cross‑functional teams.
Prioritize and delegate effectively.
Enthuse the organization and prepare for future challenges.
More About Us At Takeda, we transform patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. We foster an inclusive, collaborative workplace, committed to delivering Better Health and a Brighter Future worldwide.
This position is classified as “hybrid” following Takeda’s Hybrid and Remote Work policy.
Location:
Boston, MA
U.S. Base Salary Range:
$208,200.00 – $327,140.00
Benefits:
U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision, 401(k) plan with match, disability coverage, life insurance, tuition reimbursement, volunteer time off, holidays, and well‑being benefits. U.S. employees are eligible for up to 80 hours of sick time and up to 120 hours of paid vacation.
EEO Statement:
Takeda is proud of its commitment 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, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#J-18808-Ljbffr
Objective / Purpose Our Data and Quantitative Sciences Department (DQS) comprises more than 700 quantitative scientists who harness data to accelerate the development of highly innovative treatments. The Pharmacometrics team, part of DQS and Quantitative Pharmacology and Translational Science (QPTS), drives, implements, and executes a model‑informed drug development (MIDD) strategy for each asset from pre‑FIH through life‑cycle management within the global project team.
Position Objectives
Strategically lead and implement model‑informed drug development strategies across early and late‑phase clinical portfolios, enabling robust dose/regimen recommendations, trial designs, and go‑no‑go decisions through the life‑cycle of our products in collaboration with other functions (e.g., QCP, SQS, GEO).
Drive the implementation of automation and AI in pharmacometrics (E2E) to increase capacity, quality, and timeline efficiencies, continuously advancing the field and enabling data‑ and model‑based decision making across all phases of drug development.
Serve as a recognized expert internally and externally in mechanistic modelling and traditional pharmacometrics, demonstrating experience optimizing clinical drug development and applying MIDD principles to emerging data sources (RWD, natural history registries, omics data, HER data, etc.).
Explore and excel in synergistic relationships with experts in statistics and other data science disciplines, driving an integrated approach.
Provide portfolio support through program reviews, collaborative decision making, and best‑practice initiatives, including evaluating probability of technical success and business development opportunities.
Act as an ambassador of Pharmacometrics, Quantitative Clinical Pharmacology (QCP), QPTS, and DQS to the R&D organization and the external scientific community through scientific meetings and impactful publications.
Accountabilities
Lead and manage a team of in‑house pharmacometricians to deliver all analyses internally and externally supporting the Takeda clinical portfolio and business development activities.
Maintain relationships with external vendors to support regulatory pharmacometrics analyses.
Operate at an enterprise level, defining, leading, and driving cross‑therapeutic area and platform‑level pharmacometrics strategies that advance the Takeda portfolio through decision‑making milestones, including product valuation and reimbursement.
Lead the evolution of our in‑house modelling platform, envisioning increased automation, integration of emerging data sources, and AI with an end‑to‑end mindset, complying with GxP.
Collaborate with DMPK&M to transition and implement mechanistic modelling and thinking (PK‑PD, PBPK‑PD, QSP) into the clinical portfolio as assets progress through IND, enriching understanding and informing opportunities, populations, dosing, and trial design.
Drive pharmacometrics strategies, including MIDD, as part of the overall QDM framework, coordinating with QCP and SQS.
Represent Pharmacometrics in regulatory agency meetings and produce the technical components of clinical pharmacology summary documents for regulatory submissions.
Maintain high standards for good clinical practice, compliance, and ethics.
Participate in business development due diligence, providing evidence‑based risk assessments.
Promote and advance the Pharmacometrics vision and mission, creating delivery for the DQS mission to impact R&D business.
Serve as a role model for QCP and DQS members and act as a cross‑functional collaborative leader.
Demonstrate leadership in scientific societies and cross‑industry consortiums related to pharmacometrics (ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, DIA).
Education & Competencies (Technical And Behavioral)
Pharm D or PhD with 15+ years of quantitative experience, including extensive pharmacometrics, mechanistic modelling, statistics, or chemical bio‑engineering, plus strong management and leadership experience.
MS with 18+ years of quantitative experience, similar breadth and depth, and proven leadership.
Desired Technical Skills
Subject‑matter expert in multiple areas with leadership of internal or external focus groups.
Robust understanding of pharmacology and statistical principles.
Recognized expert in pharmacometrics and clinical pharmacology, passionate about AI and automation.
Define and lead cross‑therapeutic strategy, directing complex pharmacometrics analyses and developing innovative methodologies in partnership with other DQS functions.
Influence business‑critical decision making beyond QCP/Pharmacometrics responsibilities.
Strong mathematical and pharmacological/mechanistic training.
Experienced drug developer with full‑cycle R&D cross‑functional strategy understanding.
Extensive experience in HA interactions and submissions.
Implement MIDD strategies within global filings and approvals.
Optimize trial design, sample size, and assessment timelines using innovative processes and methodologies.
Evaluate benefit‑risk for projects, assets, and TAU decisions, managing expectations.
Establish external networks for collaboration across industry, government, and academia.
Desired Behavioral Competencies
Strong scientific and strategic leadership.
People management and leadership experience.
Excellent organizational skills for process and resources.
Effective communication with stakeholders and audiences.
Mobilize high‑performance teams.
Influence beyond QPTS and DQS.
Negotiation and conflict management in matrix cross‑functional teams.
Prioritize and delegate effectively.
Enthuse the organization and prepare for future challenges.
More About Us At Takeda, we transform patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. We foster an inclusive, collaborative workplace, committed to delivering Better Health and a Brighter Future worldwide.
This position is classified as “hybrid” following Takeda’s Hybrid and Remote Work policy.
Location:
Boston, MA
U.S. Base Salary Range:
$208,200.00 – $327,140.00
Benefits:
U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision, 401(k) plan with match, disability coverage, life insurance, tuition reimbursement, volunteer time off, holidays, and well‑being benefits. U.S. employees are eligible for up to 80 hours of sick time and up to 120 hours of paid vacation.
EEO Statement:
Takeda is proud of its commitment 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, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#J-18808-Ljbffr