Senior Director, Clinical Data Management (MPD, PDT, and VBU)

Boston, 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 R0123565 Date posted 10/28/2024 Location Boston, Massachusetts

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Job Description

Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as the Senior Director, Clinical Data Management - Marketed Product Development, Plasma Derived Therapy, and Vaccines Business Unit reporting to the Head of Clinical Data Management based in our Cambridge office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers and work towards for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

GOALS:

Effective leadership, strategic planning, and oversightfor one or severalTherapeutic Area Units (TAUs)and/or operationalunitswithin Clinical Data Management (CDM).
Set the vision, direction, and strategy for area(s) of responsibility and activelycontribute to and align with the overallCDM, Global Integrated Clinical Trial Data Services,and Global Development Organization (GDO) strategies and operating models.Lead operationalizationactivities to ensure on time, high quality and within budget delivery thatenablesuccessful trial data analyses for Takeda to delivermedicines to patientsfaster.
Champion CDMoperationalexcellenceby leading and developingflexible, scalable and innovative methodsto internalize key CDM capabilities.
Anaccomplishedpeople and relationship manager, who will establish and maintainproductivepartnerships within CDM,functional leaders across R&D, and thirdparty service providers.

ACCOUNTABILITIES:

Accountable for the timely and high-quality delivery of clinical databases for assigned TAUs, ensuring fitness of purpose and compliance to applicable regulations and SOPs.Proactively drive quality, efficiency, and innovation to ensure data management deliverables are met within the established timelines, budget, and applicable standards.
Lead the development of robuststrategies for DM resourcing, outsourcing, technologies and risk management to enable more efficient management, collaboration, and pro-active decision making.
Contribute to the overall strategicdirection of Takeda R&D and the role of clinical data management in maintaining the company’s competitive advantage and delivering on Takeda’sbusiness objectives.
Support the Head of Clinical Data Management in leadingcross-functionalefforts to build out processesand infrastructurenecessary to internalize key CDM capabilities and optimize overall operational delivery. Represent CDM on key cross-functionalinitiatives.
Drivesignificantlevels of business change, withinCDM and across the broaderorganizationto ensure the successfulexecution of the CDM strategy and operating models.
Champion harmonizationeffortsacrossregions, TAUs and service providers.
Recruit, select, develop, manage, motivate, coach and appraise the performance of direct reports. Build team commitment to goals, and create a positive and productive culture within the team. Ensure appropriate training and be a leader and mentor for all DM globally.
Lead the development of SOPs, proceduraldocumentation and continuousprocessimprovement activities in collaboration with DM leadership team. Identifyareas for simplification and innovationaswellas new and emergingenablingtechnologies.
Represent CDM in global regulatory audits andinspectionsand ensuresuccessfuloutcomesin line with business expectations.
Establish, foster and enhancerelationshipswithin and across the global organizationaswellas with service providers.
Be a deputy for the Head, Clinical Data Management asneeded.
Otherresponsibilitiesasassigned.

EDUCATION & EXPERIENCE:

Bachelor’s/MS Degree or international equivalentpreferred, or equivalentcombination of education, training and experience.
15+ years of experience with degree, or equivalency of 20+ plus yearsexperience in lieu of degree.
7+ years of line management experiencewith prior second-level management experiencerequired.
Successfulexperiencemanagingoperationalvendorrelationships and alliance partnershipsata program or portfolio level.
Proven track record of strong project management skills and experiencemanaging data management activities for large drugdevelopmentprograms.
Requiresadvancedexperience working on Phase I-IV studies across multiple therapeuticareas and programs, and be capable of leading DM activities to support regulatorysubmissions and inspections.
Excellentverbal/writtencommunication skills and ability to influenceatalllevelsacrossfunctions and build effectiverelationships.
Seasoned leader with a passion for people development and an ability toperformin ahighlydynamicenvironment.
Exceptionalinterpersonal skills, outstandingnegotiation and problem solving skills.
Focused and versatile leader whoexcels under pressure, ambiguity, frequentchange, or unpredictability.
Entrepreneurial and innovative; takes measured risks; thinksoutside the box; challenge the status quo.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$205,100.00 - $322,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. 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.

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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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

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 - 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 - Head, Global Clinical Development Operations

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.

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