Technical Lead, Nucleic Acid-based Companion Diagnostic Development
Serve as the technical and development lead for Nucleic Acid Technology (NAT)-based companion diagnostic programs. The candidate is responsible to work with internal and external cross-functional teams and drive the technical strategies and approaches for diagnostic programs at Novartis Companion Diagnostics (CDx). The candidate is accountable to oversee the technical and development activities at the external partner(s) and ensure the milestones are defined and achieved to meet program objectives.
Serve as a Technical Lead and subject matter expert for NAT-based IVD product development; work with cross functional teams (internal and external teams) to develop and execute project plans; oversee the development activities, deliverables, and milestones of external partners; and drive the success of the external programs for Novartis CDx.
- Assume technical leadership role, work with external partners to develop and execute technical strategies, identify technical risks, develop and execute project plan(s) and risk mitigation plan(s) to achieve program objectives.
- Oversee the external partners’ key development activities and deliverables, including any needed due diligence, and drive technical discussions and decisions and ensure the milestones are achieved in accordance to project timelines and budget.
- The candidate is accountable for effective execution of project plan(s), effective prioritization and utilization of resources, and on-time delivery of the major deliverables.
Key Performance Indicators
Ensure external partner(s) successful execution and completion of the technical/project plans within the defined timelines and budgets and achieve program objectives.
Ideal Background (State the minimum and desirable education and experience level)
The candidate must possess a PhD in a relevant scientific field, such as biochemistry and molecular biology with 6-8 years of industrial experience for NAT-based assay development under design control process for IVD product.
In-depth knowledge of NAT-based IVD assay and platform technologies, and 6-8 years of hands-on experience in NAT-based IVD product development are required. Technical expertise in PCR is highly critical.
Proven track record of completing the development cycles from the concept stage through V&V and regulatory submissions (PMA or 510k), and successful commercialization of FDA-regulated IVD products.
4+ years of management and leadership experiences required. Strong management and leadership skills with proven ability to direct and lead functional (assay development) team(s) and to collaborate effectively with internal and external stake holders in a highly dynamic environment.
Must display excellent leadership and people skills, especially for influencing, conflict management and team building. Experience in overseeing and managing external partners is highly desirable.
Excellent writing and verbal communication and presentation skills are essential. Experience in drafting, reviewing and editing documents required for product development, regulatory submission and quality compliance is required.
Ability to perform under pressure and adapt to changes (e.g., priorities and timelines) is essential.