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Job Description:

Objective :

This role serves as the single point of contact for R&D CMC Portfolio Strategy enabling activities on behalf of the CMC community within R&D, but also in collaboration with R&D & GMS GQ MPD GPLS on overseeing and driving our portfolio governance (R&D CMC governance office), portfolio insights and portfolio stakeholder management.

• R&D CMC Strategy Leader & Stakeholder Management: Accountable for oversight of the Pharm Sci Portfolio Strategy in Pharm Sci and R&D. Autonomously collaborates, mentors and champions CMC leads/teams to influence the development, alignment of plans with key stakeholders and oversee the execution of multiple, complex program strategies. Actively engaged in the broader pharma industry to understand CMC portfolio trends and insights. Proactively contributes to wider Takeda portfolio community to enhance communication of Pharm Sci portfolio dynamics, risks and opportunities.
• Head of Pharm Sci CMC Governance Office: Accountable for facilitating the Pharm Sci CMC Governance advisory board, comprised of senior-level CMC experts to advise Pharm Sci teams towards winning CMC development strategies. In collaboration with Head of Pharm Sci, R&D Therapeutic Area Units Strategy Leads, R&D Portfolio and other key stakeholders, deliver on the imperatives of the R&D CMC Strategy Review Board by ensuring program are reviewed and advised at key inflection points, teams are prepared with clear business plans, and decisions are clearly communicated and maintained.
• R&D CMC Digital & Industry-leading Portfolio :Develops and drives digital-based processes and mechanisms for real-time portfolio analytics towards enhancing portfolio prioritization, decision-making and delivering on business objectives. Lead the R&D CMC efforts for leveraging digital and AI tools to translate complex insights into actionable recommendations related to program and portfolio deliverables. Deliver competitive intelligence and industry benchmarking to assess R&D CMC’s position in key areas and work with portfolio teams to optimize top-tier development cycle times to accelerate drug to patients.

Accountabilities :

• Senior level R&D CMC portfolio strategy leader accountable for influencing and overseeing the Pharm Sci Portfolio Strategy. Able to clearly articulate deep technical CMC development plans and concepts to a wide variety of audiences across Pharm Sci, R&D and Commercial that includes various types of complicated, global CMC programs (pre-clinical to commercialized programs, diverse therapeutic areas, geographic footprints, and various technical platforms & modalities (for example, synthetic molecules, oligonucleotides, peptides, mAb and mAb fragments, complex biologics such as ADCs and combination products consisting of simple to complex device elements).
• Autonomously collaborates, mentors and champions CMC-leads/teams to influence the development, alignment of plans with key stakeholders and oversee the execution of individual program strategies across all programs and types. As a mentor to CMC leads/teams, able to use soft skills to cultivate a strategic mind-set for program planning that aligns with business needs. Ensures well-thought through program plans are brought to R&D governance for review. Able to see trends across programs and help others learn to adapt their thinking to avoid repeating past mistakes or adapting to the latest technology or regulatory trends (checking for blind spots, offering different and/or challenging points of view).
• Actively engaged in the broader pharma industry to understand CMC portfolio trends and insights. Deliver competitive intelligence and industry benchmarking exercises to examine and reflect relative Pharm Sci standing in key CMC portfolio development areas of CMC program development performance metrics, CMC development processes/governance, application of technology, etc. Action and lead subsequent Pharm Sci/R&D initiatives towards continual improvement of R&D portfolio strategic planning and execution. Proactively contributes to wider Takeda portfolio community to enhance communication of Pharm Sci portfolio dynamics, risks and opportunities.
• Develops and communicates solid business cases for PS strategies that motivate stakeholders to take actions.
• Utilizes industry and corporate expertise to lead and influence Pharm Sci and R&D Portfolio Strategy. Represents CMC/Device viewpoint at Pharm Sci, R&D, corporate and industry level
• Contributes to Pharm Sci portfolio planning culture towards planning to win and proactive risk management and execution excellence
• Head of R&D CMC Governance Office Accountabilities drive CMC Excellence by Facilitating the R&D CMC Governance Office Forums & Operations to deliver valuable strategic decision making across CMC portfolio. Close collaboration with Head of Pharm Sci, R&D Therapeutic Area Units Strategy Leads, R&D Portfolio and other key stakeholders, deliver on the imperatives of the CMC Strategy Review Board by ensuring programs are reviewed and advised at key inflection points, teams are prepared with clear business plans, and decisions are clearly communicated and maintained. Tracking of portfolio milestone progression and strategy across R&D – Interface with R&D Governance Office on evolving program strategy and communications to ensure programs consult CMC governance for key program planning and decision making. Providing strategic CMC development guidance and influence program leads/teams/function-heads to ensure productive and effective CMC governance process and outputs/clear and timely decisions. Deliver continuous improvements and expand awareness of CMC Governance throughout R&D, Commercial, Global Manufacturing, Regulatory and Quality.
• Develops and drives digital-based processes and mechanisms for real-time portfolio analytics towards enhancing portfolio prioritization, decision-making and delivering on business objectives.
• Lead the CMC efforts for leveraging digital and AI tools to translate complex insights into actionable recommendations related to program and portfolio deliverables.
• Help Pharm Sci Teams drive CMC excellence with development strategies that optimize R&D CMC portfolio development cycle times
• Collaborate with the Pharm Sci PMO to Develop and maintains portfolio management tools, methodologies and dashboards to facilitate effective decision making and communication across the organization.
• Lead and Support R&D and Pharm Sci strategic initiatives to improve portfolio management, program/portfolio strategy and/or execution to meet business objectives
• Identify internal strategic imperatives and develop mechanisms to effectively respond to evolving business needs
• Ensure R&D CMC leverages the most effective AI/Digital tools to enable leadership portfolio decision making
• Drive communications of on-going strategic initiatives, portfolio updates, & R&D CMC Town Halls meetings
• Primary point of contact and interface for all pipeline metrics (budget, resources, timelines, etc.), portfolio business insights and analytics for strategic planning with key CMC stakeholders (R&D, Commercial, & Research).

Education & Experience:

• Bachelor’s degree 25+ years relevant industry experience
• Master’s degree 21+ years relevant industry experience
• PhD and 15+ years relevant industry experience

Technical Skills & Competencies:

• Has in-depth knowledge of pharmaceutical development across modalities drug development, process chemistry, biologics, formulation development, analytical development, and/or statistics
• In-depth knowledge of End-to-End drug development from research to commercial including the latest regulatory or technology trends as applied to CMC development strategy.
• Outstanding communication skills including the ability to interact with all levels of management including the most senior leaders in R&D
• Must be able to directly link, and articulate to others, project/program and portfolio management capability to strategy.
• Demonstrated experience influencing and mentoring others towards CMC strategy
• Familiarity with relevant digital portfolio systems. Ideal candidates have used digital and AI tools to provide pharma portfolio insights based on analytical and qualitative assessments, translating complex insights into actionable recommendations.
• Functions well under pressure in a changing environment. Uses independent judgment to identify, plan, prioritize, and organize diversified workload as required.
• Technical, data sciences or natural sciences degree beneficial
• Ability to work well in a cross-functional team environment and drive resolution of issues while maintaining positive working relationships across functions
• Exercises exceptional time management skills and can successfully manage multiple tasks simultaneously
• Keen sense of continuous learning and improvement
• Strong external CMC industry connectivity
• Up to date on the latest CMC development trends (technology, regulatory, industry-leading contract manufacturing/testing facilities, consultants, etc.). Ideal candidates have track-record of applying industry-leading approaches to programs they have led.

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 :

$208,200.00 – $327,140.00

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.

EEO Statement:

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.

Locations:

Boston, MA

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

Job Exempt:

Yes

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.