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R&D Ethics and Compliance Advisory Lead – Director

Boston, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

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

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

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

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

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

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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R&D Ethics and Compliance Advisory Lead – Director

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Job ID R0019404 Date posted 09/17/2020 Location Boston, Massachusetts

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Job Description

OBJECTIVES/PURPOSE

Ethics & Compliance (E&C) focuses on what the organization needs by ensuring

  • Ethical behaviour plays a fundamental role in risk mitigation
  • Being a forward-thinking leader in risk identification and mitigation
  • Building a modern function supporting achievement of Takeda’s Vision 2025

E&C will respond rapidly to changing environment and business needs, it is close to the market, and encourages ethical behaviour in line with Takeda’s values. By working in an agile manner E&C ensures the balance between stable structures, governance, processes and systems, and dynamic approaches to delivering innovative solutions to appropriately manage our risks.

E&C commits to

  • Act as role model for Takeda's values, ethics and values-based decision making, fostering this mindset in clients, partners and team
  • Enable the organization to take decisions which are ethical and in line with our priorities of Patient, Trust, Reputation, and Business
  • Collaborate across all E&C teams and partner with stakeholders in BU / BF to embed ethics and compliance as part of the way everyone works at Takeda

RESPONSIBILITIES

  • Strategic partner to R&D leadership to champion and shape the organizational mindset around the Patient-Trust-Reputation-Business model to embed ethical decision making principles
  • Lead implementation of E&C strategy for R&D by influencing senior leaders and other stakeholders to embed existing ethics & compliance principles and change behavior to new trends that Takeda establishes as best practice
  • Strategic Senior Advisor to R&D on key decisions including external partnership, engagement, and clinical development activities
  • Maintain and further strengthen business expertise and nurtures cross functional relationships to enable a proactive, holistic and cross functional approach to risk identification
  • Drive understanding of overall R&D strategy, business model, pipeline for efficient support
  • Identify and evaluate emerging industry trends and laws/regulations and communicate potential impact to R&D accordingly
  • Work closely with senior leaders and cross functional partners to align on, and implement, ethics & Compliance controls to proactively manage identified risks
  • Anticipate the potential impact of his/her advice on other areas of the company and proactively collaborate and communicate with the relevant stakeholders to manage this impact
  • Partner with R&D E&C Operations to develop and carry out targeted training and communication, monitoring and risk assessment strategies  
  • Provide input into global E&C Policies/SOPs, initiatives or programs as relevant and interface with other E&C teams for R&D support
  • Demonstrate leadership within the R&D E&C organization, such as informally mentoring other team members and proactively educating other team members on relevant topics
  • Scope of R&D support to include Chief Medical Office that spans broader remit with Commercial and PVPS connectivity

CAPABILITIES

  • Learning Agility, curiosity mindset, proactive, and self-motivated & effective in a matrixed organization & stakeholder engagement
  • Ability to interact with and advise senior business leaders
  • Strong leadership skills including the ability to influence business stakeholders and lead change through effective communication and persuasion to ensure support efficiency
  • Consistently demonstrated ability to deliver results both through self and others 
  • Demonstrated ability to navigate complex ambiguous situations: ability to develop & apply pragmatic solutions
  • Demonstrated strong project and program management skills and experience in leading cross-functional projects and initiatives with a flexible, collaborative and team-oriented approach to problem solving
  • Ability to successfully handle multiple projects or initiatives with competing priorities
  • Strong business acumen and ability to build strong relationships with stakeholders
  • Excellent written and oral communication skills, and effective presentation skills
  • Strong customer service skills and ability to demonstrate executive presence while interacting with all levels of management and stakeholders
  • Proven ability to exercise strong business judgment with a strong understanding of the fundamentals of the pharmaceutical/biotech industry

EXPERIENCE

  • At least 12 years of experience in the healthcare or pharmaceutical industry, of those at least 6 years of Ethics & Compliance experience
  • R&D experience strongly desired, including in supporting Medical Affairs activities especially when intersection with commercial activities
  • Bachelor’s degree required
  • Post-graduate degree, law degree or healthcare compliance certifications preferred
  • Extensive leadership and advisor roles with substantial authority in a matrixed organization
  • Good knowledge of and experience with laws, regulations and industry guidance globally that affect the pharmaceutical industry
  • Extensive experience in aligning potential, present and future compliance & ethics risks related to the business, including risk identification, controls & risk mitigation of potential non-compliance

TRAVEL REQUIREMENTS:

  • Up to 20% travel

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • 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

Empowering Our People to Shine

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0019404

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