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Job Description

Objectives:

R&D CMC Strategy & Pipeline Insights: Develops mechanism for and drives project prioritization decisions, CMC governance, and milestones reporting. Ensuring access to relevant portfolio and program data for proactive conversations with CMC Leadership Team. This role is the primary point of contact with strategy organizations in R&D, Global Manufacturing and Commercial supporting steps necessary to enable CMC strategy are understood and aligned with across Takeda.

Head of R&D CMC Governance Office: In collaboration with Head of Pharm Sci, R&D Therapeutic Area Units Strategy Leads, R&D Portfolio and other key stakeholder, deliver on the imperatives of the CMC Strategy Review Board by ensuring programs are coming ahead of key inflection points, teams are prepared with clear business plans, and decisions are clearly communicated and maintained.

CMC Digital Portfolio Enablement: Lead the CMC efforts for leveraging digital and AI tools to translate complex insights into actionable recommendations related to program and portfolio deliverables. Collaborate with the R&D digital transformation team (AF) to leverage digital and AI to enhance portfolio prioritization, decision-making, and analytics. Deliver competitive intelligence and industry benchmarking to assess CMC's position in key areas and work with portfolio teams to optimize top-tier development cycle times to accelerate drug to patients.

Accountabilities:                                                                                                                                                      

Leverage digital and AI tools to provide insights based on analytical and qualitative assessments, translating complex insights into simple, actionable recommendations.

Collaborate with R&D digital transformation team (AF) to establish new ways of real-time and effective portfolio prioritization, decision making and analytics on key performance indicators to support individual asset and portfolio-level decision making, including at CMC Strategy Review Board

Deliver competitive intelligence and industry benchmarking exercises to examine where Pharm Sci is relative to the industry in key areas: performance metrics, CMC process (al la in silico), application of technology, etc.

Optimize R&D CMC portfolio development cycle times in collaboration with Pharm Sci Teams

As a key advisor to CMC leadership, you will play a critical part in shaping our future portfolio strategy, driving the operational execution and implementation of our portfolio strategy

Head of R&D CMC Governance Office Accountabilities include:

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

Leading and facilitation of the R&D CMC Governance Office Forums & Operations to deliver valuable strategic decision making across CMC portfolio

Providing strategic CMC development guidance and influence to program leads 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 and Quality

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

Connect CMC & R&D/Commercial strategy and operations to understand explain pipeline changes including potential risks, impacts and mitigations supported by long term strategy

Drive the data collection, analysis summary and communications of R&D pipeline metrics (portfolio aggregation assessment of prioritization and probability of success tracking metrics, etc.)

Accountable for annual CMC team goal setting strategy, process, execution tracking and routine reporting on CMC KPIs related to pipeline

Lead external benchmarking exercises with outside agencies and drive CMC & R&D leadership discussions around data insights and opportunities for improvement

Facilitate coordination for major governance interactions outside of R&D CMC with Program Leaders and CMC Leadership Team

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, & 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).

Qualifications:
 

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

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.

Must have people management experience

Must be familiar with relevant digital portfolio systems. Ideal candidate is familiar with the use of 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 latest industry trends and technology

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:

$169,400.00 - $266,200.00

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.

LocationsBoston, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull 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.