Vice President, GRA CMC, Biologics and Advanced Therapy Medicinal Products (ATMP)

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Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

How you will contribute:

Vice President, Biologics and ATMP is a critical role within GRA, Takeda R&D, responsible for managing a complex organization that spans two critical modalities. This role is crucial for the future of Takeda as it oversees the entire Takeda portfolio for biologics and ATMP, including cell and gene therapy products. The individual in this role will collaborate with multiple stakeholders in R&D, GRA, GMS, Global Quality, and Commercial to develop innovative strategies for the management of development products, regulatory conformance, and pipeline management.

Key Responsibilities:

• Manage critical portfolios for biologics and ATMP, ensuring the health and success of these portfolios for the future of Takeda.
• Collaborate with stakeholders in R&D, GRA, GMS, Global Quality, and Commercial to develop innovative strategies for the management of development products.
• Develop processes, systems, and infrastructure to assure regulatory conformance prospectively and retrospectively for products in the post-approval space.
• Work closely with colleagues in quality and commercial organizations to manage pipeline products and bring current products to industry standards.
• Represent CMC and GRA on key governance committees and play a critical role in driving the organization towards innovative approaches for the adoption and registration of new technologies and molecules.
• Lead and mentor senior individuals with varying backgrounds, enabling them to hire, mentor, and develop capable individuals who can represent the organization internally and externally.
• Interface with senior management, serving as the primary conduit for reporting performance against critical activities and as the voice of senior management to the team.
• Resolve conformance challenges with ERT programs and serve as the liaison with senior management on the issue.

ACCOUNTABILITIES

• Responsible for demonstrating Takeda leadership behaviors.  Serve as a member of the GRA-CMC Leadership team, giving input to key strategic, portfolio, human capital and financial decisions. 
• Provides leadership of GRA CMC Biologics & ATMP regulatory team and in conjunction with direct reports, manages resources, establish a vision, and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.
• In conjunction with members of the team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams and stakeholders in a timely manner
• Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and external stakeholders (Health authorities, Industry counterparts/associations, academia). Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.
• Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.
• Build and maintain communication strategy and platform for all staff across the organization.   Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet. Actively engage and influence organization to think proactively and utilize science and risk-based approach to product development and LCM activities.
• Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.
• Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
• Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally. Leads or plays a key role on the relevant internal Takeda governance committees

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.
• Languages: Fluent in English (oral and written); additional languages desirable   
• Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences
• Strong leadership skills with the ability to manage ambiguity and lead teams in high-stress situations. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
• Excellent communication skills, with the ability to communicate concisely and clearly across all levels of the organization.
• Proven ability to collaborate with stakeholders internally and externally, including regulatory authorities.
• Experience in biologics and ATMP, with a deep understanding of the industry and regulatory landscape.
• Strong strategic thinking and problem-solving skills, with the ability to make informed decisions using risk-based approaches.
• Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO).
• Actively engaged in major industry associations (e.g. EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH).
• High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams.

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.

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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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