Director, Clinical Data Management Operational Delivery

Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Data Management Operational Delivery based remotely reporting to the Vice President, Head of Clinical Data Operations and Standards.

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 toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

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

_GOALS:_

Lead global implementation and adoption of new/enhanced Clinical Data Management (CDM) processes, ways of working, and technology (e.g., CFDR), while providing enterprise-level oversight of data management (DM) delivery, study timelines standardization, and inspection readiness across assigned assets/TAUs/portfolios.

• The Director will be expected to lead implementation of new and enhanced processes, new ways of working and technology implementation projects (e.g., CFDR) within clinical data management (CDM), including:
• Lead oversight and partner across CDSO and CDOS to ensure roll out.
• Identify risks and work with CDM LT and other Cross Function leaders to mitigate.
• Coordinate with CDM LT to set initiative priorities.
• Partner with Global Development Compliance (GDC) to implement and monitor rollout of new processes, tech, and ways of working.
• Champions harmonization, change management and user adoption efforts across regions, TAUs and service providers.
• Serve as Functional Process Owner and Expert (FPE) in Takeda’s continuous improvement framework:
• Partner with process Business Process Owner (BPO), GDC, and BSO to ensure controlled and business-controlled process documents are complete, meet regulatory compliance (as applicable), and are optimized for end user needs
• Lead champion/SME network (e.g., CFDR) to embed process and tech knowledge & proficiency in CDM functional members.
• Lead and/or participate in process excellent and/or initiatives through operational implementation.
• Partner across TAUs and roles to ensure consistent approach and implementation of process and ways of working.
• Serve as lead CDM standards governance representative
• Serve as lead CDM stakeholder and partner with BSO to ensure technology aligns with CDM roadmap,
• The Director is responsible for effective leadership of setting up framework for tracking project timeline deliverables at an enterprise level for DM activities globally within and across a key asset, franchise/portfolio and/or therapeutic area(s).
• Provides enterprise view of study timelines and status across the study lifecycle for DM end to end tasks from start-up through database lock at the TAU, program(s), and/or portfolio level.
• Develop and maintain FTE and/or FSP Resourcing model and algorithm in alignment with CDM TAU LT and ensure consistent implementation across TAU according to the CDM vision
• Drives significant levels of business change, within CDM and across the broader organization to ensure the successful execution of the CDM strategy and operating models.
• Provides DM expertise in support of CDM operating model for TAU, program(s), and/or portfolio level.
• Develop and maintain CFDR stakeholder management across SET roles to support operational excellence and escalation activities
• Provide expert functional support guidance in audit readiness

Functional Service Provider (FSP) :

• The Director may have direct line management responsibilities and/or supervisory responsibility for global FSPs.
• Responsible for oversight of FSP resource allocation and DM strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.

In-Direct line management:

• Relationship manager, establishing and maintaining productive partnerships within Clinical Data Management (CDM), functional leaders across R&D, and third-party service providers.
• Champions CDM operational excellence by leading and developing flexible, scalable and innovative methods to internalize key CDM capabilities.

_ACCOUNTABILITIES:_

• Establish and maintain a framework for CDM Project Management to enable CDM LT and leads oversight for data management delivery across all global development programs within assigned asset and/or therapeutic area(s)
• Establish a mechanism for and enterprise view for study deliverable risks for Takeda.
• Provides mechanism for oversight and reporting out of achievement of major DM deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance and Statistics:
• Provides DM knowledge in CDM activities, including but not limited to the design and implementation of data capture tools
• Ensuring processes are in place (e.g., Data processing, coding, reconciliation)
• Accountable for oversight of deliverable readouts and guidance for the CDM program leads on capturing risk and mitigation collection and management
• Oversee CDM inspection readiness within assigned asset and/or therapeutic area(s).
• Represents function in external professional initiatives and organizations (e.g., SCDM, CDISC, DIA) to identify industry best practice and increase the visibility of Takeda.
• Identifies, recommends and drives changes in industry best practices and/or regulatory trends within and across TAUs.
• Other duties as assigned.

EDUCATION AND EXPERIENCE:

• Bachelor’s/MS Degree or international equivalent preferred, or equivalent combinationofeducation,trainingandexperience10+yearsofdatamanagement experience in the pharmaceutical industry.
• Expertknowledgeandsuccessfulexperiencemanagingvendorrelationshipsand alliance partnerships with at least 7 years experience in this area.
• 5+yearsoflinemanagementexperience(priorsecond-levelmanagementexperience preferred).
• Excellentverbal/writtencommunicationskillsandabilitytoinfluenceatalllevels across functions and build effective relationships.
• Seasonedleaderwithapassionforpeopledevelopmentandanabilityperformina highly dynamic environment.
• Exceptionalinterpersonalskills,outstandingnegotiationandproblemsolvingskills.
• Focusedandversatileleaderwhoexcelsunderpressure,ambiguity,frequentchange, or unpredictability.
• Entrepreneurialandinnovative;takesmeasuredrisks;thinksoutsidethebox; challenge the status quo.
• ExpertknowledgeofFDAandICHregulationsandindustrystandardsapplicableto data capture and data management process.
• Experiencewithbudgetplanning.
• Strongknowledgeofrelationaldatabasesandexperienceusingmultipleclinicaldata management systems.
• Strongknowledgeofelectronicdatacaptureanddatawarehousetechnologiesas applied to clinical trials.
• Advancedknowledgeofbroaddrugdevelopmentprocesswithexpertiseinthecross- functional interfaces with the data management function.

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:

Massachusetts - Virtual

U.S. Base Salary Range:

$177,000.00 - $278,080.00

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-term incentives. 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.