Senior Technical Product Manager R&D - Clinical Trials
- San Carlos, CA
As part of our software engineering team, Technical Product Managers (TPMs) work with our internal business partners to provide value to the organization with software products including commercial and in-house LIMS (laboratory information management system) products. We support a variety of different business units such as laboratory operations, clinical operations, R&D, process development, customer support, genetic counseling, reporting, bioinformatics, statistics and more.
TPMs need to be able to understand both the business processes of the groups we work with, and the technical details of the software to be an effective liaison for our department. This knowledge is used to discuss potential solutions and help drive decision-making, and then to be able to prioritize, translate and document those conclusions into detailed use cases and technical requirements.
For this position focused on delivering software requirements for executing Clinical Trials, you will be working on projects and maintenance for LIMS related to our Signatera cancer detection product. For this role, we're looking for someone with experience in responsibilities directly related to product management as a product manager or similar role. Having a background managing software products for executing clinical trials would be a big plus.
- Working closely with a team of technical product managers & clinical data managers who are supporting clinical operations (Clinical Trials , Investigator Initiated Trials etc.) across the organization
- Translate business, market and clinical needs into clearly written technical product requirements and specifications
- Act as a subject matter expert on our software products to provide guidance to stakeholders and create a shared understanding among business and technical teams
- Produce deliverables that facilitate better understanding for feedback such as flow diagrams, data models, pros/cons, prototypes, wireframes and other illustrations
- Build confidence with our business partners by adding value to discussions, being responsive, and following through on action items
- Maintain tracking of requests from user groups and prioritize those for time allotment and release planning
- Aid in creation and communication of product roadmap and development schedules for project stakeholders
- Incorporate a focus on quality into product design, and work closely with development and software quality assurance teams on product and process improvements
- Develop strong hands-on technical knowledge of software products and be able to aid in tasks ranging from configuration to testing and support
- Performs other duties as assigned
- BS or higher in related major or equivalent industry experience
- 2+ years of direct experience with software product management related to clinical trials, clinical diagnostics, genomics or healthcare
- Familiar with full-stack web application development
- Experience in creating commercial software product requirements
- Basic understanding of regulatory and GxP requirements including HIPAA, GDPR, HITRUST, CCPA, ISO-27001 etc.
- Basic knowledge of ICH/GCP guidelines, Clinical Research, Clinical Trial process and FDA regulations
- Excellent problem solving and analytical skills to easily break down complex problems and deliver simple and effective data modeling solutions
KNOWLEDGE, SKILLS, AND ABILITIES
Some knowledge in following areas of software development:
- Software product requirements
- Software technical design
- Software project management
- Software QA
- JIRA or similar issue tracking system
Desirable technical skills:
- DB design understanding and SQL skills
- Comfortable with Linux command line usage
- Object-oriented programming knowledge (especially Java)
- Cloud/AWS basics
Useful domain knowledge:
- LIMS, LIS, LES, and/or ELN (especially LabVantage)
- Genetics and bioinformatics
- Genomics data analysis
- Laboratory processes and instrumentation
- Laboratory software compliance requirements
- Comfortable contributing to and leading meetings with business partners in variety of positions and domain areas to receive product requests and guide decision-making
- Ability to understand and describe technical complexities in a simplified way appropriate to different audiences
- Effective written communication skills to produce clear, concise and correct technical documentation
- Ability to comprehend complex problems and apply knowledge to propose potential solutions
- Be able to break down large projects into granular milestones and track progress
PHYSICAL DEMANDS & WORK ENVIRONMENT
- Duties are typically performed in an office setting
- This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material
- Duties may require working outside normal working hours (evenings and weekends) at times
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits. Healthy catered lunches, Premium snacks and beverages, Onsite gym with cardio and weight-training equipment, Game room with satellite TV, Onsite dry cleaning and alteration service with pick-up and delivery, Employee-organized sport leagues, Happy hours and BBQs, Generous Employee Referral program.
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
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