Director, Quantitative Clinical Pharmacology (QCP) Lead

About the role

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, our people and the planet. The Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.

Responsibilities

• Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams.
• Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).
• Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions.
• Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions.
• Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DQS and external partners.
• Maintains a high standard for good clinical practice, compliance, and ethics.
• Provides mentorship to junior staff, acts as a cross functional leader and may manage a sub-team within a TA.
• Participates as a member of Business Development due diligence, when requested.
• Led infrastructure initiatives and/or cross-functional best practice initiatives.
• Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA.

Requirements

Desired education qualifications and equivalencies and desired minimum years industry experience : Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PDMS with 12+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD

• Extensive knowledge and experience with design, analysis, and reporting of clinical pharmacology studies.
• Specialized clinical pharmacology expertise in multiple therapeutic areas, development phases, and/or different regions.
• Experience in leading and driving the scoping and implementation of MIDD within projects.
• Hands-on expertise/knowledge in application of advanced knowledge in integration of multiple data sources (PK/PD/Efficacy/Safety/biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial design, and quantitative decision making.
• Experience in regulatory submission and approvals of at least one original/major NDA/CTDs or multiple supplemental NDA/CTDs (global or regional).
• Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant development milestones such as EoP2, pre-submission, and pediatric development plan (PIP and PWR).
• Strong knowledge of allied fields critical for drug development, such as statistics, drug metabolism, pharmacology, toxicology, bioanalysis, and pharmaceutical science.
• Ability to evaluate Benefit-Risk associated with project decisions, effectively manage GPT expectations and influence TA strategies.
• Leadership in cross functional decision to optimize the likelihood of drug R&D success and utilization of the quantitative decision-making framework.
• Drives efficiency using innovative processes and methodologies.
• Accelerates regional development and filings through innovation (regional QCP).

Qualifications

• Desired technical skills : Extensive knowledge and experience with design, analysis, and reporting of clinical pharmacology studies.
• Specialized clinical pharmacology expertise in multiple therapeutic areas, development phases, and/or different regions.
• Experience in leading and driving the scoping and implementation of MIDD within projects.
• Hands-on expertise/knowledge in application of advanced knowledge in integration of multiple data sources (PK/PD/Efficacy/Safety/biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial design, and quantitative decision making.
• Experience in regulatory submission and approvals of at least one original/major NDA/CTDs or multiple supplemental NDA/CTDs (global or regional).
• Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant development milestones such as EoP2, pre-submission, and pediatric development plan (PIP and PWR).
• Strong knowledge of allied fields critical for drug development, such as statistics, drug metabolism, pharmacology, toxicology, bioanalysis, and pharmaceutical science.
• Ability to evaluate Benefit-Risk associated with project decisions, effectively manage GPT expectations and influence TA strategies.
• Leadership in cross functional decision to optimize the likelihood of drug R&D success and utilization of the quantitative decision-making framework.
• Drives efficiency using innovative processes and methodologies.
• Accelerates regional development and filings through innovation (regional QCP).

Skills

• Independently executes QCP deliverables and provides solutions to complex issues.
• Consistently delivers with high quality and efficiency.
• Elevates knowledge and enhances the capability of others.
• Communicates effectively and influences in cross-functional teams.
• Inspires commitment and enables cross-function collaboration.
• Communicates success stories and shares learning across QCP.
• Focuses on priorities and delivers on commitments.

Benefits

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine: Discover more at takedajobs.com: No Phone Calls or Recruiters Please.

Pay

U.S. based employees may be eligible for short-term and/or long-term incentives. 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.

Schedule

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 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.

Equal Opportunity

Takeda is proud in 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.