Job Description

ACCOUNTABILITIES:

• Provides strategic and operational leadership for the Predictive Modelling and Biopharmaceutics function within drug product development, ensuring capabilities, priorities, and deliverables align with portfolio and business objectives.
• Builds and develop a high performing predictive modelling and biopharmaceutics team which works across the whole Oral Drug Product Development organization to drive modelling excellence and execution
• Leads the development and implementation of predictive modelling and biopharmaceutics strategies to support formulation design, dosage form selection, and product performance evaluation across development stages.
• Ensures the effective application of modelling and simulation approaches to assess biopharmaceutics risks, including absorption, dissolution, bioavailability, and in vivo performance.
• Oversees the generation, interpretation, and integration of biopharmaceutics data to enable scientifically sound and timely development decisions.
• Provides scientific and organizational leadership in predictive sciences, including PBPK/PBBM, absorption modelling, IVIVC/IVIVR, and related methodologies, to strengthen development outcomes and decision quality.
• Partners with cross-functional stakeholders across formulation, analytical, clinical pharmacology, regulatory, and CMC disciplines to incorporate predictive and biopharmaceutics strategies into program plans.
• Directs the contribution of predictive modelling and biopharmaceutics expertise to regulatory strategies and submissions, ensuring scientific rigor and alignment with applicable regulatory expectations.
• Builds and maintains organizational capability through talent development, resource planning, and leadership of a high-performing scientific team.
• Establishes standards, processes, and best practices for the use of predictive modelling and biopharmaceutics approaches within drug product development.
• Drives innovation and continuous improvement in predictive sciences to enhance efficiency, reduce development risk, and support successful product advancement.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

Deep expertise in pharmaceutical development, predictive modelling and biopharmaceutics. Proven track record of successful application of mechanistic and PPBM modelling in drug development. Ability to work in a global ecosystem (internal and external) with a high degree of complexity and address the challenge with enterprise level perspective. Ability to lead/coordinate pipeline program and cross-functional initiative by mutually aligning different constraints and priorities with relevant stakeholder

Leadership

Hires and mentors a group of predictive modelling scientists and engineers to execute Pharmaceutical Sciences in silico Modelling strategy for the oral drug product development department (ODPD). Influences direction through recognized expertise and strong cross-functional partnerships. Mobilizes and leads high-performing, cross-functional teams across multiple programs; driving alignment and disciplined execution. Champions change and inclusive leadership; develops the immediate team through coaching, mentoring, feedback, and deliberate skill building.

Decision-making and Autonomy

Operates with high autonomy and accountability to execute portfolio/program approaches, scientific plans, resourcing proposals, and partner models within agreed governance. Makes complex, risk-based decisions (or recommendations) on development approach, critical-path trade-offs, and mitigation actions across scope, budget, timeline, and quality; escalates appropriately and ensures decisions are documented and communicated. Anticipates program and capability needs and initiates actions to close gaps with minimal oversight.

Interaction

Primary internal partners include other ODPD function heads and department members, other Pharmaceutical Sciences department stakeholders in AD and SMPD, Clinical Pharmacology and Drug metabolism (DMPK) Leads/Managers; Global Regulatory; quality; procurement/supplier management; and clinical biomarker development functions. Leads external technical interactions with consultants and development partners; supports contracting and governance interactions in partnership with legal and procurement.

Innovation

Explores and evaluates emerging predictive modelling and biopharmaceutics technologies; proposes creative solutions to meet stakeholder needs and program constraints. Shares knowledge across the organization through technical reviews, best practices, and mentoring; encourages disciplined experimentation through prototyping and feasibility assessment.

Complexity

Manages team across multiple interdependent workstreams spanning device development, patient testing services, and clinical research support across a global matrix. Navigates diverse external ecosystems (partners, suppliers, regulators) and varying regional regulatory pathways; balances speed, cost, quality and patient impact while operating under strict compliance and design control expectations.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• PhD in Chemistry, Pharmaceutics, Mathematics, Statistics, Engineering or related pharmaceutical science and 8-10+ years relevant industry experience
• Master's degree in Chemistry, Pharmacy, Mathematics, Statistics, Engineering or related pharmaceutical science and 10-14+ years relevant industry experience
• Bachelor's degree in Chemistry, biology, pharmacy, engineering or related pharmaceutical science and 15-18+ years relevant industry experience.
• Extensive pharmaceutical or biopharmaceutical industry experience required, including progressive leadership responsibility in drug product development, biopharmaceutics, modelling and simulation, and CMC strategy for oral dosage forms.
• Demonstrated expertise in predictive modelling approaches such as PBPK/PBBM, mechanistic absorption modelling, dissolution modelling, IVIVC/IVIVR, and model-informed drug development to support oral formulation design and clinical performance prediction.
• Strong scientific knowledge of oral biopharmaceutics and drug product development is required, including absorption, bioavailability, dissolution, food effect, formulation performance, and phase-appropriate development of oral dosage forms.
• Experience supporting regulatory submissions and health authority interactions is required, with the ability to provide scientifically robust modelling and biopharmaceutics justifications for formulation strategy, clinical bridging, and product changes.
• Proven ability to lead and develop high-performing scientific teams, including talent development, coaching, succession planning, and establishment of functional capabilities aligned with business and portfolio needs.
• Strong cross-functional leadership and collaboration skills with the ability to influence across formulation, analytical, clinical pharmacology, regulatory, quality, and CMC teams to drive aligned decisions and integrated development strategies.
• Excellent communication and strategic thinking skills with the ability to translate complex modelling and biopharmaceutics concepts into clear recommendations for senior leaders, project teams, and regulatory audiences.
• Demonstrated behavioral competencies in leadership, sound judgment, innovation, and decision making, with a strong ability to balance scientific rigor, business priorities, and development risk in a dynamic environment.
• High learning agility, adaptability, and commitment to continuous improvement are required, along with the ability to build organizational capability, advance new scientific approaches, and foster a culture of collaboration, accountability, and inclusion.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Boston, MA

U.S. Base Salary Range:
$177,000.00 - $278,080.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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. 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.

Locations
Boston, MA

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes