Join our pioneering team at a leading R&D organization committed to delivering transformative therapies to patients globally. As the Vice President of Biologics and ATMP, you will play a pivotal role in shaping the future of our portfolio.
About Us:
At our organization, we're dedicated to unlocking innovation and pushing the boundaries of possibility in therapeutic development. By focusing on three key therapeutic areas and targeted investments, we strive to bring life-changing therapies to patients worldwide.
How You Will Contribute:
As Vice President, Biologics and ATMP, you'll lead a dynamic team responsible for managing critical portfolios in biologics and advanced therapy medicinal products. This role is instrumental in shaping the future success of our organization, overseeing the entire Takeda portfolio within these modalities, including cell and gene therapy products. Your key responsibilities will include:
Managing critical portfolios for biologics and ATMP, ensuring their success for the future of our organization.
Collaborating with stakeholders across R&D, GRA, GMS, Global Quality, and Commercial to develop innovative strategies for product development and regulatory conformance.
Developing processes, systems, and infrastructure to ensure regulatory conformance for products in the post-approval space.
Working closely with quality and commercial colleagues to manage pipeline products and elevate current products to industry standards.
Representing CMC and GRA on key governance committees, driving innovative approaches for the adoption and registration of new technologies and molecules.
Leading and mentoring senior individuals to foster talent development and representation of the organization internally and externally.
Serving as the primary conduit for reporting performance against critical activities and addressing conformance challenges with ERT programs.
Key Accountabilities:
Demonstrating leadership behaviors in alignment with Takeda's values.
Providing leadership to the GRA CMC Biologics & ATMP regulatory team, managing resources, and establishing a vision.
Developing and overseeing proactive regulatory CMC strategies and building relationships with internal and external stakeholders.
Ensuring team effectiveness in a complex matrix environment and maintaining effective communication strategies across the organization.
Contributing to the creation of an employment culture that attracts, retains, and develops effective talent.
Ensuring compliance with all applicable regulations and industry best practices.
Qualifications:
Advanced Degree or PhD in Life Sciences, Pharmacy, or related discipline.
Minimum of 20 years of experience in regulatory agencies or the Pharmaceutical Industry, including significant leadership experience in Regulatory Sciences.
Strong leadership, communication, and collaboration skills.
Experience in biologics and ATMP, with a deep understanding of the industry and regulatory landscape.
Proven ability to work across regulator/industry boundaries and drive positive impact for patients.
Familiarity with international regulations and policies of major regulatory agencies.
Engagement in major industry associations and joint regulator/industry initiatives.
Takeda Compensation and Benefits Summary:
We are committed to equitable pay for all employees and offer a comprehensive benefits package, including competitive salaries, incentives, medical, dental, vision insurance, retirement plans, paid time off, and more.
Equal Employment Opportunity:
Takeda is an equal opportunity employer, dedicated to creating a diverse workforce and providing equal employment opportunities to all employees and applicants.
Locations: Boston, MA
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
Employment Type: Full-Time
Salary: $ 252,000.00 396,000.00 Per Year
