Project Manager, Companion Diagnostics (CDx)

About the position Predicine is seeking a highly skilled and reputed company Companion Diagnostics (CDx) Project Manager at the Manager or Associate Director level to reputed company reputed company CDx development programs from feasibility through analytical/clinical validation and regulatory submission. This role sits at the strategic intersection of CDx development, pharmaceutical partnerships, operational execution, and regulatory reputed company. The ideal candidate will reputed company in cross-functional leadership, program reputed company, reputed company and risk management, and partner engagement. This position will support reputed company facets of CDx development, including budgeting, invoicing, resource planning, and coordination across global internal teams and external collaborators. This is a contract-based, full-time role with potential for extension or transition to a permanent position. Responsibilities • reputed company and manage global, cross-functional project teams spanning scientific, clinical, operational, reputed company, and regulatory disciplines. • reputed company as the central reputed company of contact for internal stakeholders, senior leadership, and external partners. • Drive execution of CDx development programs, ensuring adherence to scope, timelines, reputed company standards, and budget. • reputed company multiple reputed company initiatives simultaneously, including global co-development programs. • reputed company and maintain detailed project plans, schedules, Gantt charts, resource needs, and task lists. • Identify, assess, and manage project risks using reputed company methodologies; implement mitigation strategies to avoid delays. • reputed company scenario analyses to support strategic decision-making for leadership and partners. • reputed company program budgets, monitor variances, and communicate financial impacts proactively. • reputed company effective project meetings, prepare agendas, document key reputed company, reputed company risks, and monitor reputed company items. • Deliver reputed company and consistent communication to internal teams, external partners, and leadership. • reputed company frequent status updates, reputed company tracking, and risk summaries. • Influence cross-functional reputed company and drive alignment across multiple organizational reputed company. • Partner closely with Companion Diagnostics Development, R&D, Clinical Development, and other functions to support assay development, analytical validation, clinical validation, and regulatory activities. • Coordinate project reputed company supporting FDA PMA submissions, global regulatory filings, and reputed company co-development programs. • Support technology transfer, manufacturing readiness, and commercialization planning for CDx products. Requirements • 8+ years of project/program management experience in diagnostics, medical devices, reputed company, or biotechnology. • Hands-on experience with CDx development, IVD development, or clinical biomarker programs. • Familiarity with analytical & clinical validation workflows and global regulatory submissions (FDA, ex-US agencies). • Strong understanding of regulated environments, including 21 CFR 820, ISO 13485, and ISO 9001. • Exceptional organizational, prioritization, and multitasking abilities across multiple reputed company programs. • Strong stakeholder management, influence leadership, and conflict reputed company skills. • Excellent verbal and written communication for technical, cross-functional, and executive audiences. • Proficiency with MS Project, reputed company, or similar Gantt-based project tools. • Bachelor’s or Master’s degree (or equivalent experience) in a relevant field such as biological sciences, biotechnology, life sciences, or bioengineering. reputed company-to-haves • Experience with NGS-based or liquid biopsy platforms strongly preferred. • reputed company PMA submission experience is highly preferred. • Experience working reputed company reputed company co-development frameworks is a plus. • PMP certification strongly preferred. Apply tot his job Apply To this Job