The Associate Director, Companion Diagnostics Development will be responsible for ensuring that objectives of new CDx projects at Illumina are set in alignment with the IVD partner and Illumina business needs, are implemented and are accomplished within the defined time-frame and budget. The Associate Director CDx Development will in partnership with Illumina Alliance Management, serve as a facilitator of interactions between the external Diagnostic Partners and the internal Illumina stakeholders.
- Creating and executing enterprise wide CDx project work plans with Diagnostic partner and internal teams, and modifying as appropriate to meet changing needs and requirements
- Working with Business development to present Illumina Companion Diagnostic abilities to potential pharma partners and KOLs
- Assisting program management with complete tracking of all project phases and activities – communication of timelines, milestones and goals to project team and department leadership
- Ensuring that project documents are complete, current, and available to team in a centralized location
- Participating in preparation of slides and alignment of communications and decision processes in partnership with CDx Lead
- Communicating issues and minimizing risks as well as creating associated mitigation strategies for all ongoing CDx projects
- Organizing and facilitating global CDx team meetings and interactions with Dx partner
- Minimum 7 years (w/BS), 5+ years (w/MS), 3+ (w/PhD) relevant experience in pharmaceutical/diagnostics setting and managing complex development projects
- Qualified candidates must have a Bachelor’s degree from an accredited college or university; Candidate will have a degree in biological sciences or a related discipline. PhD strongly preferred
- Experience in Companion Diagnostics strongly preferred.
- Experience developing IVD or LDT oncology products is required
- Demonstrated track record of success working on a multidisciplinary pharma/diagnostic development team.
- Knowledge of design control, market and product requirements management, and the IVD development process is required
- Knowledge of molecular diagnostics technology, competitors, and market space is preferred.
- Established expertise and hands-on experience with Microsoft Project, Word, Excel, PowerPoint, Outlook, Sharepoint and remote meeting tools such as WebEx, Live Meeting
- Expert planning and tracking skills, with the ability to capture details and summarize in an integrated cross-functional plan
- Well- organized, focused on results, capable of managing multiple projects, excellent time management skills.
- Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas
- Solid interpersonal and verbal and written communication skills
- Excellent presentation skills required
- Domestic and international travel may be required
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