Director, Device Development Lead

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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.

Pharmaceutical Sciences (Pharm Sci) organization is an integral part of global R&D at Takeda translating science into therapeutic products for patients. When you join Pharm Sci, you become a part of a team dedicated to bringing our products to life for our patients through innovation, dedication and talent while considering sustainability aspects.

Join us as a Director, Device Development Team Lead (DDL) where you will have a high impact leadership role responsible for leading the global device team (GDT) in the development of the product device strategy, including technology/platform choice, partner selection, device clinical strategy, device regulatory strategy, etc. In this role you will be accountable for delivering excellence in leadership, device strategy development, and implementation of the strategy in alignment with Pharmaceutical Science (PS), Global Project Teams (GPTs) and Therapeutic Area Unit (TAU) goals/KPIs.

How you will contribute:

• The DDL role requires a talented leader with proven expertise in overseeing cross-functional, global team activities and is expected to be knowledgeable about the overall device development activities and global regulations.

• This role would be accountable for delivering excellence in leadership, device strategy development, and implementation of the strategy in alignment with Pharmaceutical Science (PS), Global Project Teams (GPTs) and Therapeutic Area Unit (TAU) goals/KPIs.

• The DDL communicates with governance bodies, and represent the device sub-team at the GPT, GPT sub-teams, functional governance forum and Takeda Program Review Committee (PRC) as required.

• Lead and drive development and execution of strategic device plans, Target Device Profile (TDP), and LCM/geographical expansion plans, ensuring alignment to GPT product strategy.

• Represents GDT on GPT and accountable for device development inputs on GPT activities for their portfolio and for implementing the GPT asset strategy into the GDT development plans.

• Represents GDT on other key strategy teams such as the Global Manufacturing Sciences (GMS) Product team and commercial launch team.

• Drive program execution excellence, develop and lead high performing GDTs.

• Efficient and timely escalation of urgent issues / risks to the PS Leadership team, GPT, and other stakeholders.

• Promote visibility and transparency of information within the GDT, across GPT and GPT sub-teams to accelerate decision making, obtain alignment, and increase foundational knowledge.

• Demonstrate strong finance and business acumen and oversight of the device program budget.

• Creates an environment that inspires confidence, trust and commitment through effective communication and personal actions.

• Willingness to travel to various meetings including overnight trips. International travel will be required.

• Requires approximately 10-20% travel.

Minimum Requirements/Qualifications:

• Must have a degree in a scientific/engineering discipline. BS with at least fifteen (15) years, MS with at least twelve (12) years or a PhD with at least eight (8) years of device development and commercialization with demonstrated success leading multi-site, global or enterprise-wide programs in the biotech/pharmaceutical industry.

• Knowledgeable in at least one functional area (proven experience) in the development of a pharmaceutical device.

• Proven Leader with ability to manage multiple complex cross-functional teams and processes to deliver key accountabilities.

• Demonstrated experience managing programs in different stages of development.

• Strong knowledge and understanding of global device product development and commercialization in the pharmaceutical industry.

• Must have demonstrated experience and competency in using program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring.

• Must have demonstrated experience and aptitude in preparing and supporting Chemistry, Manufacturing and Control (CMC) documentation enabling clinical development and commercialization (e.g., 510(k), INDs, IMPDs, BLAs, NDAs and MAAs).

• Polished communication and presentation skills, including executive level written and oral recommendations and communications for global and cross-functional communications.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

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.

Base Salary Range: $160,300.00 to $229,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time