Director, Global Program Management - Companion Diagnostic-

Role Summary

Director, Global Program Management - Companion Diagnostic. Join us as a Director, Global Program Management in our Cambridge office. The Oncology Companion Diagnostic Program Manager (CDx PM) role is an exciting opportunity within the Oncology Therapeutic Area Unit (OTAU) at Takeda. The primary focus is to drive efficient and effective CDx strategy execution for early- and late-stage Oncology programs, including development and delivery of diagnostic workplans, on-time test development and deployment in global clinical trials, interfacing with internal stakeholders and external diagnostic partners, and supporting health authority meetings and regulatory submissions.

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.

Qualifications

• 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.
• 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 ‚Äì 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 ‚Äì Strong project management skills, exercises good time management/prioritization skills and can successfully manage multiple tasks simultaneously.
• Motivated ‚Äì Self-motivated and willing to accept temporary responsibilities outside of initial job description.

Skills

• Cross-functional collaboration
• Program management
• Biomarker data interpretation
• Regulatory awareness for global CDx pathways
• Vendor and contract management

Education

• Master Degree or Ph.D.