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 pharma-sponsored Companion Diagnostic (CDx) In Vitro Diagnostics (IVD’s) through the full development lifecycle, from feasibility through to analytical and clinical validation
This will require interacting with a cross-functional, multi-disciplinary team in order to meet the requirements for successfully launching CDx IVD’s on the Personalis Next Generation Sequencing platforms. The position will coordinate the following activities:
- Manage CDx IVD programs in coordination with R&D, Operations, Business Development, and the Regulatory/Quality teams
- Tracking of Timelines, Milestones, Deliverables, Resources and Costs.
- Oversee biopharma partnership product development activities. This includes Personalis development of laboratory developed tests, for use in clinical trials and development of CDx IVD products being submitted for Regulatory approvals (US, Ex-US).
- Lead, plan, execute and finalize projects.
- Lead communications with pharma partners’ (CRO’s) for Pharma-partnered Programs.
Ideally, the candidate will have a strong working understanding of program management, and CDx IVD development. Prior experience with managing complex IVD projects, 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 biopharma partnerships at Personalis.
- Facilitate Program requirements
- Lead program initiation, once contracts are executed.
- Assist Business Development with development of biopharma program proposals.
- 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 CDx, IVD program management.
- Manage the Program interfaces & stakeholders (internal & external incl. development, CRO’s and CDx partners); manage Program costs within approved budget and report on actuals versus planned.
- 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.
- 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, and presentations to Program sponsors, internal and external (partner) stakeholders and appropriate governance bodies.
- 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 0-5%.
- BS, MS, PhD in biological science, Molecular Biology, Biochemistry, Genetics, Cancer Genomics, 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).
- Communicating and managing relationships with client stakeholders.
- 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.