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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 15-18+ years relevant industry experience
- Master's degree 14-16+ years relevant industry experience
- PhD and 8-10+ 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:
$174,500.00 - $274,230.00
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.
Top Skills
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world.
We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.
Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.
Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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