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 c