Director, Global Program Management - Companion Diagnostic- jobs in United States
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Takeda · 2 months ago

Director, Global Program Management - Companion Diagnostic-

Takeda is a patient-focused, innovation-driven company transforming the pharmaceutical industry through R&D-driven market leadership. The Director, Global Program Management will lead the Companion Diagnostic Program, ensuring effective strategy execution and collaboration across various teams to drive timely delivery of diagnostic workplans and regulatory submissions.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Provide operational excellence to the Companion Diagnostic Working Group and Translational Subteam of the Global Program Team
Provide operational support in the development and execution of companion diagnostic strategy including program level deliverables (clinical biomarker and diagnostic plans, data interpretation, collaborations), diagnostic elements of governance presentations; and developing resource recommendations as needed
Collaborate with cross-functional team members to develop and deliver companion diagnostics in alignment with therapeutic programs
Coordinate companion diagnostic program team meetings with internal team members to implement the program CDx strategies. Schedule team meetings, develop agendas, as well as capture minutes and track action items
Support Joint Project Team meetings with external diagnostic partners
Build companion diagnostic project plans, timelines, and risk mitigation strategies for CDx development activities (with both internal team and external diagnostic partner) and work with GPM to implement into broader program plan.  Interact with potential diagnostic vendors and clinical sites to support the plan
Contribute to the planning and tracking of program budgets and resource allocations,
Develop project planning documents and archive project materials to ensure visibility of both project history, current status, and future directions
Drive execution of companion diagnostic project plan, including assignment of responsibilities and tracking of internal and external deliverables.  Maintain a risk register for companion diagnostic deliverables
Support timely delivery of biomarker data and analyses to drive decision making, project advancement/milestone transitions and resource allocation across functions
Ensure coordination of key decisions and milestones by close collaboration across Translational Scientific Leaders, Companion Diagnostic Leads and key cross-functional stakeholders such as Clinical Operations, Clinical Biomarkers, Clinical Sciences, Oncology Drug Discovery and Regulatory Sciences to successfully deliver, communicate and execute companion diagnostic strategy for projects and platforms
Drive timely decisions and accountability within the team and facilitate active communication and information flow between translational team members, stakeholder functions, and governance bodies
Leverage program management best practices to facilitate cross-functional translational and companion diagnostic team meetings fostering a team culture of transparency, accountability, high cross-functional communication and accountability, and timely execution
Contribute to broader translational matrix by sharing ideas, tools, best practices and lessons learned

Qualification

Companion diagnostic developmentPharmaceutical drug developmentProject management best practicesBiomarker-driven clinical trialsRegulatory pathways understandingAnalytical skillsOrganizationMotivatedTeamworkCommunication

Required

Master Degree or Ph.D
5-8 years of experience in pharmaceutical drug development with a focus on companion diagnostic development
Strong companion diagnostic development experience required
Broad knowledge of key companion diagnostic deliverables including clinical assay and IUO device development, sample tracking and management, experience working with external partners and contract laboratories, data delivery, project management best practices and proficiency with supporting project management tools
Experience with delivering and overseeing CDx contracts with external partners and vendors
Proven experience managing companion diagnostics or IVD programs
Have background in understanding of drug-diagnostic co-development and regulatory pathways
Experience with biomarker-driven clinical trials and clinical data integration
Understanding of key considerations relevant to global regulatory requirements
Experience developing team culture, resolving conflicts, and driving decision-making in a matrix environment
Teamwork – Ability to work well in a highly cross-functional team environment
Communication - Able to express oneself clearly and concisely within team; documents issues and/or concerns concisely; timely and effectively communicates issues to supervisor and team members
Analytical and problem-solving skills. Able to troubleshoot critical issues or problems, determine causes and determine and implement solutions
Organization – Strong project management skills, exercises good time management/prioritization skills and can successfully manage multiple tasks simultaneously
Motivated – Self-motivated and willing to accept temporary responsibilities outside of initial job description

Benefits

Short-term and/ or long-term incentives
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
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation

Company

Takeda

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Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.

H1B Sponsorship

Takeda has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)

Funding

Current Stage
Public Company
Total Funding
$2.46B
2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M

Leadership Team

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Christophe Weber
President and CEO
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Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
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Company data provided by crunchbase