Senior Director, Global Regulatory Lead Oncology at Takeda Pharmaceuticals

Senior Director, Global Regulatory Lead Oncology

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.

Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody-drug conjugates (ADCs), complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide.

Join Takeda as a Senior Director, Global Regulatory Lead Oncology, where you will be part of the global regulatory team. In this influential role, you will lead a top-priority program, building cross-functional teams capable of translating complex challenges and ideas into actionable strategies. You will set global regulatory direction, provide expert guidance, and lead late-stage projects to ensure innovative and robust strategies are in place from development through registration and launch readiness for high-impact oncology programs.

Responsibilities include:

• Leading global regulatory strategy for assigned programs across development stages.
• Providing strategic, operational and tactical regulatory insight on one or multiple complex global oncology projects in clinical development.
• Serving as global regulatory lead (GRL)/ Franchise global regulatory lead (GRL) on cross-functional teams for priority programs.
• Leading the Global Regulatory Teams (GRT) accountable for the development of innovative global strategies in line with applicable regulations.
• Ensuring alignment of global regulatory strategies with leadership team.
• Accountable for US FDA submissions and approvals of project(s) of responsibility.
• Ensuring all submission types are executed on time with high quality.
• Collaborating with all Takeda regions to ensure a global regulatory strategy is created and executed upon.
• Partnering with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies.
• Developing/authoring and executing global regulatory strategies for complex strategies.
• Monitoring and anticipating trends that impact both the regulatory and access environments.
• Demonstrating Takeda leadership behaviors.
• Leading regulatory assessment as part of due diligence teams for licensing opportunities.
• Identifying and proposing solutions to management for any resource gaps for assigned project(s).

Minimum requirements/qualifications include:

• BSc/BA Degree, scientific discipline strongly preferred.
• Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred.
• 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience.
• Experience in reviewing, authoring, or managing components of regulatory submissions including for Late-Stage assets.
• Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
• Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Must work well with others and within global 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" following Takeda's Hybrid and Remote Work policy.

#LI-Hybrid

#LI-AA1

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.

For Location: Boston, MA

U.S. Base Salary Range: $212,000.00 - $333,190.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.