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Vice President, GRA CMC, Biologics and Advanced Therapy Medicinal Products (ATMP) - Philadelphia Pennsylvania
Company: Takeda Location: Philadelphia, Pennsylvania
Posted On: 05/03/2024
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt 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 committeesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
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