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 Program Manager leads development of Personalis Clinical and In Vitro Diagnostics (IVD’s) through the full development lifecycle, from feasibility through to analytical and clinical validation and regulatory approval for new Companion CDx claims.
This will require interacting with a cross-functional, multi-disciplinary team in order to meet the requirements for successfully launching Clinical Products on the Personalis Next Generation Sequencing platforms. The position will coordinate the following activities:
- Manage Clinical IVD programs in coordination with R&D, Operations, Business Development, and the Regulatory/Quality teams
- Track of Timelines, Milestones, Deliverables, Resources and Costs.
- Oversee IVD product development from feasibility through to analytical validation, clinical validation, regulatory submissions, clinical trial sequencing. This includes Personalis laboratory developed tests and IVD products being submitted for FDA approval and companion diagnostic development.
- Lead, plan, execute and finalize projects.
- Lead participation in Biopharma clinical trials and compliance discussions with Investigational Device Exemption requirements.
- Lead communications with our pharma partners for Pharma-partnered Programs.
Ideally, the candidate will have a strong working understanding of genomics, next generation sequencing, and IVD’s. Prior experience with project management tools, gant charts and leading team meetings, is highly desirable. This role will have a unique opportunity to manage and contribute to the development of new clinical platforms at Personalis.
- Facilitate Program initiation and scope definition.
- Manage development of Clinical and CDx Program proposals.
- Participate in design and execution of validation studies to support clinical programs.
- Support the Program sponsor in preparation of business cases and project plan preparation for external partner or CDx Programs; recommend subsequent scope and budget changes where necessary.
- Key liaison representing Personalis to pharma partners on all aspects of Clinical program management from assay development to commercialization.
- Manage the Program interfaces & stakeholders (internal & external incl. development and CDx partners); manage Program costs within approved budget and report on actuals versus planned.
- Conduct and lead product development Programs and teams; Manage resources, coordinating all efforts within Personalis, including third-party services or consultants in order to deliver Programs according to plan.
- Define and manage Program success criteria & risks and disseminate them to involved parties throughout the Program life cycle;
- 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 Program 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.
- Develop and deliver progress reports, proposals, and presentations to Program sponsors, internal and external (partner) stakeholders and appropriate governance bodies.
- 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.
- Coach, mentor, motivate and supervise Program team members and contractors, and influence them to take positive action and accountability for their assigned work.
- Develop best practices and tools for Program execution and management in interaction with other Program and/or program managers.
- Travel - Domestic travel 10-20% of for partner meetings and FDA meetings
- BS or MS in biological science or related field.
- 4+ years working in industry (IVD or Pharma).
- Program and or Project Management in a Diagnostic or Biopharma environment.
- Involved with products in a regulated environment (such as with FDA-CDRH/CDER, CLIA, CAP).
- Communicating and managing relationships with client stakeholders, ideally Pharma or Biotech.
- 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).
- Program and project management tools.
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.