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Dir Clin Dev Services-Metrics, Analytics & Reporting at Millennium Pharmaceuticals, Inc. in Boston, Massachusetts

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

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Job Description

Position Title:

Director, Clinical Metrics, Analytics, Reporting and Technology

OBJECTIVES: 

The overall purpose of this position is to provide global leadership, strategic direction and oversee implementation of Clinical Metrics, Analytics, Reporting and Technology (CMART) through cross functional stakeholder collaboration.  The categories below are CMART’s core capabilities:


  • Technology Innovation and Data Governance

  • Metrics, Reporting & Analytics

  • Technology Management and Support

                              

ACCOUNTABILITIES:

Accountable for building the new CMART capability, strategy development and implementation oversight for the Clinical Metrics, Analytics, Reporting and Technology (CMART) capabilities including:

Technology Innovation and Data Governance


  • Develop the Global Development Support (GDS) operational components of the Technology Roadmap and Governance in partnership with Clinical Information Operations (CIO), GDS Leadership, cross functional stakeholders and R&D IT; Ensure an agile technology strategy in support of an outsourced trial operating model including considerations for oversight requirements, predictive trial delivery and industry best practices

  • Oversee and manage the implementation of the operational components of the GDS Technology Roadmap; Seek opportunities to establish platforms and systems across GDO and R&D functions wherein selected platforms can integrate easily or leverage same platform to provide greater value to Takeda

  • Lead R&D cross functional operational data domain working group (in collaboration with the Data Sciences Institute) and in accordance with the Data Quality Council and R&D Data Governance policies; Establish and maintain data governance, definitions, source of truth and monitor data quality; Provide input to the enterprise data catalogue based on operational data domain working group decisions

Metrics, Reporting & Analytics

  • Oversee the development and manage Global Development Office (GDO) operational trial delivery reporting, insights and analytics roadmap aligned with business needs to support oversight of clinical trial heath and data driven decision making (e.g., Study and Site Health, Partnership Balance Scorecard, Sponsor Oversight, TMF Health, Study Predictive Risk etc.); Lead and/or participate in internal and external performance and benchmarking analysis; Seek opportunities to innovate and expand predictive analytic capabilities

  • Work closely with GDS and CDS leadership to promote utilizing operational data to support decision making, risk evaluation and prioritization as it relates to clinical trial health, oversight and predicative trial delivery; Ensure CMART provides opportunities to collaborate with GCO, GDS and cross functional stakeholders to educate colleagues on how to effectively share data and leverage data to support decision making

  • Management of the Global Takeda trial and activity listing solution to support GxP required regulatory authority trial and activity listing requests (e.g., PSMF Trial Listings, Aggregate Safety Listings, Regulatory Authority Trial Listing etc.)

  • Oversee trial listing report requests for regulatory inspections, audits, GDO Leadership, TAU requests, LOCs R&D Tax reporting, etc.

Technology Management and Support

  • Serves as the Business System Owner for GCO and GDS operational systems (e.g., Veeva Vault Clinical, Nexus, CTMS etc.); Oversee and manage Business System SMEs including system implementation and enhancements ensuring compliance with system development life cycle and 21 CFR Part 11 requirements (as applicable and in collaboration with IT and QA)

  • Oversee and manage end-user training, access and central support model for GCO and GDS managed operational systems and/or inputs into R&D systems (e.g., Veeva Vault Clinical, CTMS, Trial Listings Solution, HCP Engagements etc.)

  • Oversee and manage the vendor operational data feeds into the R&D data hub and data quality checks in collaboration with DSI and CIO; Engage cross functional R&D stakeholders to ensure data needs across vendor data feeds are met

  • Oversee CMART operational data quality monitoring process for GCO and GDS to comply with the operational data domain work group standards, clinical trial listing regulatory reporting and ensure inspection readiness

Talent Development:

  • Promote and implement measures to support enable a positive workplace, collaboration, talent development and growth for CMART team

Other duties as assigned.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

Education: Bachelor’s degree and/ or Advanced degree

Experience: Minimum of 10 -12 years of experience with Advanced degree or 15+ years for Bachelor’s degree in pharmaceutical, CRO, healthcare or related industry. Knowledge and/or experience within clinical trial operations and clinical trial lifecycle. Prior experience in process development management, inspection readiness, TMF and clinical systems. Solid understanding system development lifecycle requirements and of US CFR, GCP, ICH and the clinical development process. Understanding and experience within a global regulatory environment is desirable.

Behaviors/ Competencies:


  • Strong leadership skills with wide range of global R&D stakeholders

  • Ability to present complex strategies and information to a variety of audiences

  • Strong adaptive communication skills across multiple levels of the organization

  • Excellent written, verbal and project planning skills

  • Strong attention to details

  • Self-starter with demonstrated success working independently.

  • Self-motivated with comfort working on high performance teams.

  • Tolerance of ambiguity and willingness to work through complex issues

  • Ability to work with global external partners to achieve desired goals

  • Ability to develop solutions to complex issues and challenges

  • Promotes team work while working through solutions

  • Knowledge of R&D technologies and data sources

PHYSICAL DEMANDS: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


  • Ability to sit and stand for long periods of time.

  • Carrying, handling and reaching for objects.

  • Manual dexterity to operate office equipment i.e. computers, phones, etc.

TRAVEL REQUIREMENTS:

Requires approximately 5-10% travel, including overnight and international travel to other Takeda sites to support regulatory inspections.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time