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Job Description

About the role:

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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as the Associate Director, CMC Program Lead in Allogeneic Cell Therapies. You will be responsible to collaborate across Cell Therapy CMC functions and RA functions to deliver CMC pipeline and CMC platform projects. You will sit within Cell Therapies CMC team and is a highly visible matrix leadership role accountable to broader program and functional stakeholders through Cell Therapy program and technical team structures to support the strategy and execution of CMC activities in scope for a given project. Success in this role depends heavily on strong cell therapy development experience, broad technical understanding of core and extended CMC functions, strategic thinking, keen problem-solving abilities, excellent leadership skills, and a proven ability to influence in a matrix environment. This is a hybrid role.

How you will contribute:

• Lead a CMC matrix teams to deliver Cell Therapy pipeline projects and platform CMC projects.

• Drive strategy development and lead execution of all phase-appropriate CMC activities in scope for given project (e.g. supporting program regulatory filings, critical cross-functional capability building, etc.).

• Represent CMC team in technical, program and governance discussions.

• Escalate issues, risks with recommended mitigation strategies across CMC line functions and per program governance procedures.

• Leverage project management best practices to develop and communicate plans and risks to all stakeholders.

• Maintain broad awareness of global regulations and industry practices for the development of cell therapies spanning phase-appropriate pre-clinical and CMC studies.

• Develop a culture of transparency, accountability, high cross-functional communication, and timely execution within the project CMC team.

• Periods of significant travel required depending on specific project needs.

• Leadership skills combined with excellent communication skills and the ability to positively influence colleagues, key decision makers. Ability to work well and manage personnel in a highly cross-functional team environment.

• Independently manages workload and expectations.

• Represent Cell Therapies CMC team in technical, program and governance discussions.

• Working with cross-functional teams and ability to align, motivate, and empower team members. Ability to work well in a highly cross-functional team environment.

• Critical thinking and problem-solving skills and ability to articulate and drive risk-based decision making.

• Leading cross-functional teams and drive global CMC strategy.

Minimum Requirements/Qualifications:

• Must have a degree in a scientific discipline.  BS with at least fifteen (15) years, MS/PharmD with at ten (10) years or a PhD with at least five (5) years of drug development experience in the pharmaceutical industry.

• Experience in CMC and Cell Therapies strongly desired, including allogeneic therapies.

• Leadership skills combined with excellent communication skills and the ability to positively influence colleagues, key decision makers. Demonstrated ability to work well and manage personnel in a highly cross-functional team environment.

• Ability to work independently and collaboratively, along with good organizational skills, and able to drive multiple projects to successful, timely completion in a fast-paced, global environment.

• Must have demonstrated experience and aptitude in preparing and supporting Chemistry, Manufacturing and Control (CMC) documentation enabling early clinical development (e.g. IND’s)

• Must have experience in pharmaceutical drug development and the regulatory submission process.

• Demonstrated ability to form, lead, manage and negotiate cross-functional and cross-regional teams.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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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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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