Associate Director, Site Start Up and Maintenance
Zurich, Canton of Zurich- 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 Organization (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.
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Job Description
The Associate Director, Site Start-Up and Maintenance plays a pivotal leadership role within the global clinical operations team. This position is responsible for overseeing the strategic planning and execution of global site regulatory, budgeting, and contracting maintenance activities. The role ensures the delivery of high-quality, timely site maintenance services by collaborating closely with internal and external stakeholders.
Objective / Purpose:
TheAssociate Director, Site Start Up and Maintenanceis responsible forline management of assigned staff, as well as defining, developing, and delivery of the global siteregulatoryand site budgeting and contracting maintenancetasks,by partnering withinternal and externalstudyteammembers.
Provide guidance to staff and oversee the analysis of clinical trial intelligence data and its application to effectively conductaccurateand effectiveresourcingforecasts, robustplanning, andon time delivery ofsitemaintenance tasks.
Directly support priority orhighly complexprojects through study closure.
Champion thecreationandimplementationof innovativeprocesses,methodologies, data andtechnologiesthatwillensureongoingdelivery ofvaluedsite startup and sitemaintenanceservices.
Accountabilities:
Responsible for line management, mentoring, and development of assigned staff
Accountable for defining, developing, and delivery ofsitemaintenance tasks
Partners with CRO's, Clinical Operations teams, and TAU partners to improve overall metrics and implement processes
Provides guidance, oversight, and training to theSiteStartUpand Maintenance Teams, delivering activities in support of Clinical Programs, including data and methodologies forefficient and effectivesite maintenanceplanning, and modeling
Ensures consistent standards are applied to thesite maintenanceprocess across project portfolios and supports continuous improvement activities while developing and implementing TA-aligned strategies / approaches
Drives the creation and implementation of innovative solutions to improve processes and acceleratesite maintenancetimelines
Leverages leading industry tools and data sources to provide data on timelines and performance toassiststudyteams with studysitemaintenancetimeline forecasting
Agrees to deliverables on a country and site-level basis with thestudy teamandmonitoradherence to these. Promptly recognize and remediate potential delays, and escalate non-performance as needed.
Leads the cross-functional sitemaintenanceteam,utilizingtheappropriate teammembers to support thestudysite maintenancerequirements
Serves as point of escalation andassistsin resolution of issues
Act as a role model for Takeda’s values
Education & Competencies:
BS degree or international equivalent in a life sciencerequired, advanced degree preferred
Extensive experience (≥ 8 years) in Clinical Operations, Project Management, study start-up,site budgeting and contractingand / or trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO orrelevantindustry vendorrequired
More than 5 years of direct responsibility in site management and oversight of the site maintenanceprocesses of clinical research studies at a sponsor or CRO
Expertisein clinical trial regulations and ethics committee submissions
Expertisein site contract and budgetamendments administration
Expertisewith leading edge trial optimization vendors, tools, and methods
Experience in line management and workingin amatrixenvironment
Proficiencywith software models and database structures
Expertiseinprinciplesdriving sitemaintenancestrategiesincluding site contract amendments
Direct experience in the pharmaceutical industry or related fieldrequired
Ability to stronglydemonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operationaldelivery
Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop,collaborateand lead within a global matrixed team
Ability to explain data,facilitatedecision making processes to be data driven
Locations
Zurich, SwitzerlandWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWhere 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.
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Advance clinical research
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Deliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity
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Enable end-to-end management of clinical supply
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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.
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.
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Integrity
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Fairness
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Honesty
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Perseverance
Working at Takeda
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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. -
Great Place to Work
Recognized for our culture and ways of working, we’re proud to be Certified as a Great Place to Work® in 25 countries and regions. -
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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Our products The work we do transforms lives. -
Patient story: Rosie Watch this video to learn about the extraordinary journey that Rosie and her parents have endured.
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