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Associate Director/Director, Standards Strategy and Operations

Cambridge, Massachusetts
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  • Job Type: Full Time
  • Job Level: Senior
  • Travel: Minimal (if any)

Within Takeda’s Data Sciences Institute, we harness the insight of data and digital to speed the development of new medicines to patients. The Data Sciences Institute (DSI) is primarily focused on getting medicines to patients faster through innovation and efficiencies driven by data and analytics.

We nurture a culture that encourages disciplined risk-taking, supports innovation, values diversity and emphasizes implementation.

We want to hire and develop the best talent to join us on our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine!

Job ID R0113689 Date posted 01/05/2024 Location Cambridge, Massachusetts

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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.

Join Takeda as a Director, Clinical Data Standards where you will be responsible for driving the strategy for Takeda’s global data standards, processes, and technologies across the clinical data continuum for quality of deliverables and global data interoperability. You will also actively participate in and influences Data Standards forums (internally or externally) to maintain awareness of any initiatives and trends that could be incorporated into or enhance Takeda's Therapeutic Area Clinical Data Standards Library.  As part of the Data Standards team, you will report to the head of clinical data standards and work with groups across the data science team.

How you will contribute:

  • Supports enforcement of Takeda's Global Data Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations.
  • Actively leads the identification, review/evaluation, deployment and usage of technologies to generate, distribute, and/or integrate with and report on standards compliance internally, and manages in-house programs along with standards vendor(s) to support Standards Management vision.
  • Builds relationships across the global Takeda organization and with CROs/strategic service providers, provides project management leadership of standards projects and has the ability to partner closely with internal/external standards stakeholders, and serves as a resource to support questions raised by regulatory agencies.
  • Leads and guides key Clinical Data Standards initiatives, including development of work plans, budgets, risk mitigation, and support standards strategies.
  • Contributes as an active member of standards leadership and governance teams:
  • Actively participates in and contributes to the senior leadership team by setting short- and long-term strategies, goals, and tactics.
  • Develops and manages key relationships with teams both within and outside Clinical data standards organization.
  • Demonstrates enterprise leadership and thinking among and across cross-functional partners.
  • Leads cross-functional working teams to:
    • Align plans across the Clinical data standards organization and lead strategic initiatives and planning processes.
    • Facilitate alignment with other business units and functions across Takeda.
    • Ongoing tracking and management of business priorities and initiatives and following up on open tasks related to governance.

Minimum Requirements/Qualifications:

  • BS/BA or MS in a life science or analytical area with a minimum of 8-12 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation.
  • Minimum of 8-12 years of clinical data management and/or database or statistical programming experience in pharmaceutical industry or health related field.
  • Thorough knowledge and understanding of standards development processes, focused on clinical data with a strong knowledge of CDISC, HL7, OMOP, ICH, ISO standards and an understanding of global privacy regulations.
  • Proven track record for development and management of standards library in addition to in-depth knowledge of study design implementation, to define standards eCRFs, edit checks, best practices in EDC and other data acquisition sources.
  • Knowledge of statistical programming languages (e.g., SAS, R, Python, etc.).
  • Desirable technical expertise (e.g., Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS, familiarity with Rave and/or Veeva.
  • Expertise in the requirements and technology required to support electronic data capture and electronic submissions.
  • Proven track record in identifying and implementing organization-wide initiatives, standards, and processes.
  • Proven track record in managing global, cross-functional standards and processes, support a culture of continual improvement and innovation; promotes knowledge sharing. 
  • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
  • Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.
  • Pragmatic and willing to drive and support change and comfortable with ambiguity. 
  • Direct experience in the pharmaceutical industry or related field required.
  • Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus.
  • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering programs with complex business deliverables.
  • Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
  • Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

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: $143,500 $205,000, 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.

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

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
Apply Now

Where you fit in

When you join our Data Sciences Institute team, you’ll connect with a diverse and talented group of scientists, engineers and analysts. Together, you’ll define cutting-edge algorithms, conduct pharmacology-based modeling and explore new approaches to data services. In a collaborative environment marked by strong, open and honest leadership, you’ll take charge of your professional advancement as you work on important projects that grow your skills and lead to ongoing opportunities.

A career within the Data Sciences Institute at Takeda will give you everything you need to succeed professionally. You’ll see up close that what you do with information and insight has the power to impact the lives of patients — today and for generations to come. Working here, you’ll understand that our people-first perspective extends beyond patients to include our Takeda team, our families and the communities where we all work and live.

  • Work with various data sources

  • Apply a breadth of methodologies

  • Develop analysis pipelines

  • Design studies

Being able to predictably deliver on our portfolio priorities is where we have laser-focus each and every day. By doing this, we keep our eye on the prize of bringing new medicines to patients, and show the value that these treatments can bring to their lives.
headshot of simon davies

Simon Davies - Head, Statistical & Quantitative Sciences, Data Sciences Institute

We’re using the newest technology and methods, like wearable devices and machine learning, to better understand the health of patients participating in our trials.
headshot of ariel dowing

Ariel Dowling - Head, Sensing & Measurement, Digital Health Sciences

The energy, professionalism and commitment that I experienced in every encounter, starting from the interview process, to meeting with the hiring manager, through to receiving an offer, left me feeling a certain level of consistency and thoughtfulness. That made me really feel enthusiastic.
headshot of brian johnson

Brian Johnson - Head, R&D Technology, Data Sciences Institute

How you'll shine

Many talents one goal

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

Cambridge, Massachusetts


View Map of Cambridge, Massachusetts

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