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

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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:

U.S. Base Salary Range:

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.