Associate Director, Clinical Document Management and Trial Support at Millennium Pharmaceuticals, Inc. in Lexington, Massachusetts

Job Description:

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Job Description

Responsible for overseeing Clinical Document Management outsourced activities across TMF external vendor, CRO Partner and niche vendors(s).

Develop and implement clinical trial support resource planning and forecasting, TMF Health and compliance tools and dashboards to support TMF management, inspection and clinical operations trial support strategies which are consistent with business priorities and commensurate with risk and trial complexity.

ACCOUNTABILITIES: 

• Defines and oversees execution of TMF outsourcing activities in collaboration with TMF outsourcing partner including staff resources and TMF tools and deliverables


• Oversees TMF external provider contract team and associated operations ensuring optimal use of resources and cost efficiency


• Leads CRO partner collaboration on the delivery of TMF evaluation process adherence and optimization and TMF health providing visibility on deliverables, successes and issues as appropriate.


• Manages the decision- making process on CRO TMF deliverables, issue escalation and resolution, and ensures effective flow of information between internal and external stakeholder including CRO partner and operating model, systems and technology and Global Clinical Operations leads


• Provides visibility into TMF Health and Inspection risks working in collaboration with Clinical Analytics and Reporting to provide actionable insights for Clinical Document Management, Global Development Support (GDS), Global Clinical Operations (GCO) as appropriate.


• Works in collaboration with Head of CDMTS to determine long range plans for TMF outsourcing activities, resource needs and budget requirements.


• Collaborates with internal GDS and external CRO and niche Partners on operating model optimization and implementation, participating in cross functional periodic optimization projects as


• required.


• Promotes use of TMF outsourcing tools, resources and data to support R&D in trial delivery, inspection readiness and risk mitigation


• Leverages clinical trial milestone data and defined GCO and GPT trial goals to develop resource forecasting for TMF and Clinical Trial support recommendations which are consistent with business priorities and supports resourcing planning for CDMTS and alignment with GCO and GDS.


• Lead and participate in process optimization initiatives and provide input/identify opportunities to leverage TMF health data, resourcing prediction models and TMF outsource models to optimize trial support which is scalable


• Develop and implement predictive forecasting model(s) to support long range plan for resource and outsource models


• Partners with Takeda’s CRO partners and other Takeda business units related to operating model alignment and process optimization


• Contributes to and may lead defined GDS initiatives and departmental goals and objectives.


• Supports management of decision- making process, issue escalation and resolution, and ensures effective flow of information between senior leaders both internal and external related to document management issues, trial support and inspection readiness which impact GDO.


• Contributes to development of TMF process, outsourcing and inspection readiness strategies in support of successful regulatory filings and inspection readiness for Takeda.


• Other duties as assigned.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

Education & Experience:  Bachelor’s Degree or international equivalent required; Life Sciences preferred. 

• Minimum 8 years’ experience in clinical operations with a thorough understanding of cross functional clinical processes.


• Demonstrated successful experience in project/program management and matrix leadership


• Comprehensive knowledge of regulatory requirements governing clinical trial document management and industry best practices is essential.


• Experience establishing and leading teams


• Strong leadership skills with wide range of global stakeholders


• Demonstrated ability to develop and propose independent plans and strategies sufficient to gain alignment with senior management and other functional leads.


• Solid communication skills and strong customer focus with ability to interact with internal customers at all levels of the organization. 


• Excellent teamwork, organizational, interpersonal, and problem-solving skills


• Demonstrated ability to think and act strategically


• Demonstrated ability to work independently, take initiative and complete tasks to deadlines.


• Demonstrated ability to supervise Manager level staff and lead teams to meet company objectives


• Requires strong attention to detail, organization skills, establishing priorities, scheduling and meeting deadlines.  Must be able to independently present information to management.


• Ability to interpret new and applicable legislation and Takeda Policy, identify possible process adjustment, training and communication needs to support the department.


• Ability to communicate effectively with external vendors to ensure resolution of issues or address process adjustments.


• Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing tasks and demands.


• Ability to think globally and work successfully within a cross-functional team.


• Advanced computer proficiency


• Demonstrated ability to be flexible and to adapt quickly to change


• Exposure to regulatory inspections and audits

TRAVEL REQUIREMENTS:

• Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners and in support of regulatory inspections.

• Location: Cambridge - Virtual


• Base Salary Range: $136,500-180,000 based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off


• If candidate is not eligible for any benefits or other comp., those can be excluded

This posting is made in compliance with Colorado’s Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq

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Full time