Senior Director, Global Regulatory Lead – Oncology

Takeda•Boston, MA

9d•Hybrid

About The Position

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.

Requirements

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.
Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory
Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
Must work well with others and within global teams. Able to bring working teams together for common objectives.
Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

Responsibilities

Lead global regulatory strategy for assigned programs across development stages.
Provide strategic, operational and tactical regulatory insight on one or multiple complex global oncology projects in clinical development with focus on innovative ways of addressing barriers to development strategies as well as accelerating access of our products to patients
Will be responsible for complex and potentially multiple projects within the Oncology TAU.
Interfaces with the Global Project Team (GPT) to lead and support cross-functional company objectives.
Serve as global regulatory lead (GRL)/ Franchise global regulatory lead (GRL) on cross-functional teams for priority programs, providing strategic input and regulatory expertise.
Leads the Global Regulatory Teams (GRT) accountable for the development of innovative global strategies in line with applicable regulations to achieve business objectives for development of Oncology products.
When necessary, seeks expert advice and technical support from functional stakeholders and senior management.
Acts independently under the direction of a Global Regulatory Portfolio Lead and/or TA Head.
May participate in or lead regulatory and company initiatives.
Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRT members.
Ensures alignment of global regulatory strategies with Leadership Team.
Presents meaningful regulatory assessments and regulatory recommendations to management.
Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercise sound judgement and communicating in a professional and timely manner.
Accountable for US FDA submissions and approvals of project(s) of responsibility.
May serve as the primary FDA point of contact for projects of responsibility.
Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA)
For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.
Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
Responsible for demonstrating Takeda leadership behaviors.
May lead regulatory assessment as part of due diligence teams for licensing opportunities.
Identify and propose solutions to management for any resource gaps for assigned project(s).

Benefits

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.

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