Program Lead, CDx Development
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
The Program Lead of CDx Development works on the development of Companion Diagnostics (CDx) through the full development lifecycle, from analytical validation through commercial launch of new Pharma CDx claims. This will require supporting a cross-functional, multi-disciplinary team in order to meet the requirements for successfully launching a CDx within the Tempus platform. This position manages all program management activities in collaboration with a cross-functional team including but not limited to participation in clinical trials and compliance with Investigational Device Exemption requirements, analytical validation, clinical validation, regulatory submissions, clinical trial sequencing, CDx commercialization, and many more activities.
The candidate will be responsible for leading communications with our pharma partners. Ideally, the candidate will have a strong working understanding of genomics and next generation sequencing. This role will have a unique opportunity to manage and contribute to the development of a new CDx platform at Tempus.
- Key liaison representing Tempus to pharma partners on all aspects of CDx program management from assay development to commercialization
- Ensure internal and external milestones, deliverables, and obligations are met; manage milestone payments and activities, contractual obligations, and invoicing / payment oversight
- Manage internal teams to execute all project deliverables; lead cross-functional internal team across participation in clinical trials, assay development, bioinformatics, quality, regulatory, delivery
- Partner collaboratively with the Regulatory Affairs and Quality Assurance Teams to ensure that all procedural and FDA submission documentation meets pharma partner standards
- Support the timely processing and reporting of our sequencing results to our partners and their collaborators
- Take ownership of key partner-related issues and work with appropriate internal teams to resolve
- Travel - Domestic travel 10-20% of for partner meetings and FDA meetings
- Master’s Degree in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or related field
- 7+ years working in industry and/or academia in a laboratory setting
- Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field
- 10+ years of working experience in industry
- Experience in:
- Assay development, including working under design controls, analytical and clinical validation plans
- Clinical Trial Sequencing
- Developing, implementing and supporting assays in a regulated environment (such as with FDA-QSR, CLIA, CAP, ISO regulations)
- Complying with requirements for labeling and promotion of FDA regulated diagnostic tests and drugs
- Communicating and managing relationships with client stakeholders, ideally Pharma or Biotech
- Communicating with regulatory bodies
- Participating in Pharma audits
- Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
- Demonstrated track record of timely completion ahead of deadlines
- Demonstrated ability to work in a dynamic fast paced team environment
- Strong interpersonal skills that include excellent skill in collaboration and problem solving with other departments and colleagues
- Understanding of HIPAA, GCP, and importance of privacy of patient data