Education: Bachelor's degree or related field
Experience: 12+ years
- Translate the overarching ADC translational medicine strategy and vision into integrated, detailed project plans (scope, milestones, critical paths, dependencies, risks) across biomarkers, diagnostics, and clinical development - Monitor progress versus plan; proactively identify issues and interdependencies, escalate as needed, and coordinate cross-functional mitigation plans - Schedule, structure, and run ADC project team meetings (set agendas, pre-reads, minutes, action logs), track and drive closure of decisions and actions - Build and maintain governance-ready views (dashboards, status summaries, decision logs) to enable the ADC TM Lead to present and drive decisions at R&D governance, ADC MDTs, and external boards - Serve as the operational interface between internal teams and external partners (e.g., Joint Project Teams, diagnostic manufacturers), ensuring deliverables, timelines, and obligations are clearly understood and met - Support the ADC TM Lead and functional heads in forecasting and tracking TM resource needs (FTE, external partners) for the ADC portfolio; flag constraints and propose options - Coordinate diagnostic and biomarker-related budgets (as relevant): track spend vs. plan, support PO/invoice workflows, and reconcile against contracted scopes - Maintain oversight of relevant contracts and SOWs with external diagnostic partners to ensure alignment with TM plans and timelines - Establish and maintain a structured risk and issue management process for ADC TM activities (identification, impact assessment, mitigation/contingency, owners, timelines) - Ensure operational readiness for key TM and Dx milestones (e.g., data readouts, regulatory interactions, diagnostic readiness packages) and coordinate cross-functional readiness checks - Support compliance with regulatory and quality expectations by organizing documentation and tracking contributions to regulatory submissions and inspection-readiness activities related to biomarkers/Dx - Coordinate timelines and dependencies for generation of key translational data (biomarker, PK/PD, diagnostic) across studies, ensuring alignment with decision points and governance dates - Partner with scientific and data teams to build integrated status and insight reports that enable the ADC TM Lead to deliver succinct translational data narratives to ADC core teams and governance - Maintain shared repositories (SharePoint, dashboards, trackers) for TM plans, data summaries, and decision histories to improve transparency and continuity - Identify and implement operational improvements to increase TM team efficiency and focus on high-value scientific work - Provide high-quality project management support to the ADC TM Lead in their role as Senior Matrix Leader (e.g., preparing cross-indication overviews, aligning tumor indication leads on timelines and dependencies, consolidating risks) and act as a trusted PM advisor to the TM Lead, offering scenario analyses (timeline, cost, risk) to inform their strategic decisions on TM plans and resource allocation
- Bachelor's degree in biological sciences or related discipline; advanced scientific degree a plus - Proven track record of applying project management methodologies in complex, matrixed environments; - Significant experience (typically 8-12+ years) in oncology drug development - Extensive project or program management experience supporting biomarker and/or diagnostic development programs in the diagnostic, pharmaceutical, or biotech industry - Knowledge and experience in drug discovery and development, clinical trial design, principles of clinical development, as well as Dx development, including analytical and clinical validations, and regulatory submissions - Experience managing clinical biomarker and in-vitro Diagnostic development programs with a solid understanding of the scientific operational needs, including outsourcing processes, vendor management, and scientific study plans - Established expertise and hands-on experience with Microsoft Project or equivalent, Microsoft office applications, remote meeting tools such as MS Teams, WebEx, etc. and a working understanding of innovative AI technologies (e.g., Claude, CoPilot, ChatGPT, GiGi, Jules, etc.)
- Excellent process and project management skills gained in a matrix organization - PMP or PRINCE2 certification a plus - Advanced scientific degree a plus - Ability to manage and track projects to obtain desired business objectives - Experience with data, AI, or real-world evidence initiatives - Highly effective communication skills (verbal, written, and presentation) for a wide variety of audiences/stakeholders, including technical and business - Ability to interact effectively across boundaries using influencing and relationship building skills - Capable of understanding and analyzing the complex, technical details and issues associated with operationalizing clinical biomarkers and Dx; ability to proactively anticipate, identify and resolve issues and hurdles - Demonstrated ability to think strategically and execute multiple projects simultaneously
Skills Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations
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