Monogram Biosciences, Inc.(a wholly-owned subsidiary of LabCorp), is a leader in developing and commercializing innovative diagnostic products to help guide and improve the treatment of HIV, HCV, and other viral illnesses, as well as cancer and other diseases. Monogram's services enable health care providers to optimize treatment regimens for their patients. Monogram also supports pharmaceutical companies in developing new and improved antiviral therapeutics and vaccines and targeted cancer therapeutics. Located in South San Francisco, Monogram provides an innovative and flexible work environment, where you will have the opportunity to be part of pioneering new diagnostics technologies.
The CDx Program Management Director position will provide Project Leadership to new and future Companion Diagnostic (CDx) Single-Laboratory-Use Assay development efforts within the framework of Monogram's QSR-820 compliant Quality Management System (QMS). The primary role for this position is to focus on leadership of multidisciplinary product-specific Project Core and other teams through all phases of CDx product development and commercialization in the US and select OUS markets. Experience working within, building and improving QSR-820 compliant product development systems is critical. Experience with ISO and other OUS quality systems requirements is highly desired.
The position may be required to train, supervise and develop additional Project Management and CDx Development personnel at Monogram.
- Facilitate and lead internal CDx Project Core Teams through all required phases of the QSR-820 compliant product development and commercialization lifecycle. Supervision of additional CDx Project Managers may be included in this responsibility. Key responsibilities are listed below:
- Core Team and other meeting facilitation, documentation, and follow up.
- Project-level documentation management including documentation ownership and review, Design History File management, design review facilitation, project schedules, and other assigned responsibilities (e.g. requirement traceability matrices)
- Facilitate, document and coordinate required communications between internal project teams and LabCorp/Covance, Pharma sponsors, and other partners/providers.
- Lead through example by being constantly driven to achieve successful outcomes and meet deadlines individually, with teams and management.
- Participate and provide Monogram-specific project management on various client-facing projects to meet specific needs of potential markets outside of the US
- Partner with Quality Assurance, Regulatory, R&D, Business, and Operational leadership to implement, maintain and improve Monogram's QSR-820 product development processes and procedures
- Support Business Develop efforts
- Complete other projects as may be assigned including additional responsibilities related to Monogram's clinical trials management and new product development
- BS/BA, preferably in the sciences or other technologies. MBA or other advanced degrees a plus
- Minimum 12 years of CFR Part 820 compliant diagnostic product development experience including at least 5 years of project management experience working with project teams and management to manage projects, establish and maintain processes, policies, and systems
- IVD development experience preferred. Pharma/CDx experience desired
- Knowledge of biotech assay technologies and gene/cell therapies highly desired
- Excellent communication, interpersonal and influence skills
- Strong computer skills, including Excel, Power Point, Project Planning and Word
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