Head, PharmSci Clinical Production & Alliances (Vice President)

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Job Description

OBJECTIVES/PURPOSE:

The Pharmaceutical Science (PS) Head of Clinical Production & Alliances (CPA) provides global leadership and overall strategic direction for: the production of all of Takeda’s clinical trial materials, as well as creating internal capabilities for this clinical production. This position directs the following three positions to achieve this:

• Global PS manufacturing operations across all sites (Cambridge, MA; Lexington, MA; Shonan - Yokohama, Japan; Vienna, Austria)

• Global Planning , Project Management and Oversight for capital projects  

• External Partnership Management including CDMOs and Device Suppliers

• In addition, this role is directly responsible for internal partnership interfaces across R&D and with GMS/GQ

ACCOUNTABILITIES:

• Lead the finalization and implementation of a new Early Clinical Manufacturing Strategy including oversight of design, construction and start-up of new facilities to provide Takeda with the capability to manufacture its own early phase clinical trial materials, a portfolio that will amount to over 500 OKY in assets.

• Collaborate with cross-functional teams, including process development, quality, regulatory, and supply chain, to ensure seamless integration of facilities into the broader organization.

• Provide technical leadership and support to ensure that facilities(s) are fully optimized for efficient and flexible operation, operate under phase-appropriate GMP, and follow all other applicable regulations (e.g. environmental, labor,  etc)

• Set the strategic direction for PS site operations and global and local partnership operations in collaboration with other Takeda functions and external stakeholders.

• Responsible for strategy and operating model for PS external partnerships including CDMO, Medical Device supply partners, and Clinical Testig Organizations, ensuring satisfaction of PS stakeholder needs

• Accountable for seamless interfaces with internal R&D partners including but not limited to Research, CEI, TAUs, Global Development Office, GRA ensure optimal planning and escalation processes.

• Drive the overall partnership with Global Manufacturing and Supply (GMS) and Global Quality (GQ) organizations and develop working frameworks as needed to support efficient implementation of the product operating model (to commercialize new medicines). Ensures effective internal collaboration across PS and with the PSPL organization for effective execution against the frameworks at the asset level.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• Sufficiently deep understanding of the pharmaceutical industry  

• Experience in/familiarity with Supplier Relationship Management (CMO or CDMO)

• Significant experience in running operations

• Ability to obtain a robust understanding of Quality Systems supporting cGMP manufacturing and testing.

• Experience with FDA and/or EMA inspections preferred

Leadership

• Demonstrated ability to work across functions, regions and cultures 

• Enterprise level leadership with the ability to inspire, motivate and drive results 

• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing 

• Proven skills as an effective team player who can engender credibility and confidence within and outside the company 

• Ability to distil complex issues and ideas down to simple comprehensible terms 

• Executive leadership presence and confidence 

• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization 

• Ability to develop and drive a Global Workforce and Talent strategy for all colleagues in the Global, Regional and Local organizations 

Decision-making and Autonomy

Broad decision-making responsibilities:  

• Ability to make highly complex decisions that impact the enterprise 

• Accountable for decision making for designated function

• Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions 

• Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution   

• Accountable for designing and implementing vision and strategy for designated scope 

Interaction

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace 

• Ability to effectively implement R&D’s partnership strategy 

• Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner 

• Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions 

Innovation

• Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation 

• Comfortable challenging the status quo and bringing forward innovative solutions 

• Ability to take risks implementing innovative solutions, accelerating time to market 

Complexity

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity 

• Breadth of knowledge required across therapeutic areas, indications, and/or modalities

• Ability to work in ambiguous environments (R&D) 

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Advanced degree preferred with extensive experience in the biopharmaceutical industry,

• Proven experience in leading and managing facility capital projects

• Excellent project management skills, with a track record of leading successful projects in a cross-functional team environment. 

• Strong communication and interpersonal skills, with the ability to build and maintain positive relationships with internal and external stakeholders.

• Ability to think creatively and critically, with a strong problem-solving mindset.

• Ability to work independently and as part of a team in a fast-paced and dynamic environment.

• Senior management experience in leading a medium to large organization and influencing senior-level management and key stakeholders 

• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables 

• Operational experience in pharmaceutical drug development with significant direct exposure to clinical and CMC development 

• Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions. 

• Health care business acumen with a comprehensive understanding of the pharmaceutical industry 

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:

U.S. Base Salary Range:

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.

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Job Exempt