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Senior Director, Global Import/Export Operations & Trade Compliance

Lexington, Massachusetts
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  • Job Type: Full Time
  • Job Level: Senior
  • Travel: Minimal

At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Office (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.

Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.

At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.

Job ID R0109881 Date posted 10/25/2023 Location Lexington, Massachusetts

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Job Description

OBJECTIVES/PURPOSE

Provides leadership and direction for global import/export operations and trade compliance team members. This position is responsible for providing strategic direction and oversight of processes relating to the international movement of materials in support of Takeda’s research and development programs. Responsible for ensuring that international movement of materials to support R&D programs is compliant with all applicable laws and regulations in the relevant countries. This position interacts with and influences all functional areas within Takeda involved in the import/export of research materials. Identifies and leads the development, execution, and implementation of initiatives that improve processes, enhance stakeholder relationships, and provide significant value to the business.

ACCOUNTABILITIES :

  • Responsible for providing leadership to the Import/Export Operations and Global Trade Compliance teams within GCSC including talent development, training, and team building activities. 
  • Responsible for developing, implementing, and maintaining policies and procedures that support and respond to governing international trade policies to ensure full compliance with US and international regulations regarding import and export of materials used in our clinical trials or Research.
  • Develops, leads, and optimizes, as appropriate, the GCSC importation and exportation strategy by working closely with key stakeholders to ensure all material used in clinical trials and research and development activities is moved in accordance with the rules and regulatory requirements of Customs, FDA, USDA and other applicable governmental agencies world-wide.
  • Establish best practices, set, and maintain high performance standards across the team and with the vendor network supporting the team’s activities.  Establish mechanisms for early identification of poor performance, and work to address.  Establish and monitor continuous improvement initiatives and performance measures.
  • Responsible for managing all matters of foreign trade relating to the import and export of all Clinical Trial Material (CTM), ensuring all product movements meet the compliance expectations of each country in concert with the timeline needs of Takeda’s clinical trials and Research.
  • Acts as the primary respondent to the border regulatory agencies formal inquiries and issues related to the importation or exportation of Takeda R&D business. Investigates and develops strategy and response to ensure compliance in accordance with appropriate laws and regulations.
  • Proactively identifies and drives the development, execution, and implementation of cross functional initiatives that improve import, export, and global trade compliance processes, enhance stakeholder relationships, and provide significant value to the business.
  • Responsible for operational oversight of vendor performance (logistics providers, brokers, etc.) and supplier relationship management.
  • Ensures line management and key stakeholders are apprised of developments that may impact global import/export operations and/or trade compliance, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of success for the solutions.
  • Establish and maintain strong stakeholder relationships and drives effective collaboration with internal customers to ensure service standards are being followed and optimized.
  • Develops, analyzes and implements process and procedures for tracking and ensuring documentation compliance of material shipments for Takeda and vendors. Investigates and manages resolution of potential issues to ensure Takeda remains in compliance with appropriate regulations and laws.
  • Provide technical support and trade data to CRO and packaging vendors conducting import/export activities on behalf of Takeda, as well as provides consultation to other Takeda entities relative to process improvements and policies on import and export compliance activities.
  • Ensure that a trained staff is in place, new SOP’s /guidelines/templates are written as needed and all procedures are consistent with current global regulatory requirements for Import/Export
  • Responsible for bringing significant industry expertise to the team and guiding/mentoring junior members of the team to build and maintain strong capabilities within GCSC.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Supply Chain/Logistics or related discipline.  Advanced degree preferred.
  • 15+ years pharmaceutical industry experience with R&D material management/clinical supplies/logistics, including several years of experience in importing and exporting in pharmaceutical industry. 
  • Significant job-related experience in global import and export operations and trade compliance including use of systems and tools to support these activities ( i.e. GTM, SAP, etc.)
  • Demonstrated ability to collaborate with diverse internal and external groups toward development of globalized approaches.
  • Thorough understanding of the clinical development processes including clinical trial material processes (distribution, etc.) and associated logistics requirements and challenges.
  • Demonstrated strong and effective leadership capabilities including the ability to successfully deliver complex cross functional initiatives.
  • High-level relationship building and influencing skills – can gain buy-in for ideas and proposals and generate consensus among stakeholders.
  • Strategic/enterprise mindset; capable of creating and articulating a vision and inspiring team members to strive toward the attainment of goals.
  • Builds an inclusive work environment and develops the organization for the future.
  • Has an enterprise mindset and can focus on the few priorities that matter.
  • Ability to influence stakeholders from many technical disciplines and at many levels
  • Excellent communication and organizational skills are required. 
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Customs Brokerage License (if regionally permitted)

Base Salary Range: $198,000 to $283,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. 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.

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
Apply Now

Where you fit in

As a member of GDO, you will play an important role in bringing forward our rich pipeline of life-changing products to help patients. You will find enriching engagement and a mindset of continuous improvement through creativity, innovation and diversity.

We are a global organization present in the U.S., Europe and Asia with colleagues located in several additional countries to strategically support our business needs. But our people, and the culture they build, are the foundation that sets GDO apart. Our belief in putting people first extends beyond patients. It includes their families and communities, and also our Takeda colleagues and our families.

Working closely with GDO colleagues and key stakeholders across R&D, you will leverage our new operating model and innovative technologies to accelerate the development of our current and future portfolio to bring medicines to patients faster.

  • Advance clinical research

  • Deliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity

  • Enable end-to-end management of clinical supply

  • Ensure safety management and inspection readiness

The culture at Takeda is very unique. It’s a culture that’s extremely collaborative in nature, requiring people from diverse backgrounds to come together, speak up, and really think about the most important thing we need to do for our patients.
Saurabh Awasthi

Saurabh Awasthi - Executive Director, Trial Insights & Performance Optimization, Global Development Office

One of the main reasons I came to Takeda is because of the people I would be working for.We all use PTRB as our North Star. I think that makes it easier to delegate decisions and empower each level of the organization to contribute in a meaningful way.
Marisa Rackley

Marisa Rackley - Head, Clinical Site Startup & Engagement, Global Development Office

It’s leveraging technology, it’s leveraging data in a very different way. It’s not just about using the data that we generate, but using real world data and having access to a much more holistic set of data in order to drive the way we work and deliver medicines to patients.
Penny Carlson

Penny Carlson - Head of Innovation and Data, Global Development Office

The heart of our work

Shining a light on new perspectives

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Exterior of Takeda Building

About our location

Lexington, Massachusetts


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