Personalis is a rapidly growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. Our ImmunoID NeXT Platform® is enabling the development of next generation immuno-oncology therapeutics and diagnostics.
The Associate Director leads Clinical development activities of Personalis In Vitro Diagnostics (IVD’s) and partnerships for companion diagnostics (CDx).
This will require interacting with internal stakeholders and CDx partners to meet the clinical development activities that include assessment of therapeutic clinical protocols, authoring the diagnostic clinical protocols and reports for the Personalis Next Generation Sequencing (NGS) platforms. The position will coordinate the following activities:
- Author diagnostic clinical study protocols, clinical plan, and clinical study report.
- Manage Clinical team with the IVD programs in coordination with, medical affairs, business development, regulatory and the Quality teams
- Track timelines, milestones, deliverables and resources
- Oversee IVD, clinical validation, clinical operation, regulatory submissions and clinical study management. This includes Personalis laboratory developed tests and IVD products being submitted for FDA approval and companion diagnostic development.
- Lead participation in partner clinical studies and compliance discussions with Investigational Device Exemption requirements.
Ideally, the candidate will have a strong working understanding of clinical development, clinical study protocol writing and genetics for medical devices. Next generation sequencing experience is a plus. Prior experience and leading team meetings are highly desirable. This role will have a unique opportunity to manage and contribute to the development of new clinical platforms at Personalis.
- Lead clinical development activities for Clinical and CDx Programs.
- Lead in design and execution of clinical validation studies to support clinical programs.
- Submit study protocols and other documents for IRB approvals
- Support the Program sponsor in preparation of clinical plan.
- Key liaison representing Personalis to academic and pharma partners on all aspects of Clinical Development.
- Manage the clinical interfaces & stakeholders.
- Ensure internal and external milestones, deliverables, and obligations are met.
- Partner collaboratively with the Regulatory Affairs and Quality Assurance Teams to ensure that all procedural and FDA submission documentation meets quality standards.
- Take ownership of key partner-related issues and work with appropriate internal teams to resolve.
- Travel 0-5%
- MS or PhD in biological science, Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or related field.
- 4+ years working in industry (Clinical, IVD or Pharma).
- Clinical development or clinical operations in a Diagnostic or Biopharma environment.
- Involved with products in a regulated environment (such as with FDA-CDRH/CDER, CLIA, CAP).
- Background in medical devices
- Familiar with Electronic Data Captures (EDC) platforms.
- Familiar with Trial Master File (TMF)
- Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow.
- Demonstrated track record of timely completion within 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.
- Strong people management skills, influencing and interpersonal skills.
- Team player.
- Result oriented.
- Able to work under pressure.
- Strong communication skills.
- Strong planning and organizational skills.
- Excellent knowledge of English (written and spoken).
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.