Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
Location: Remote in the United States
About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role: The Director, Business Development is responsible for business development activities for Foresight Dx and is accountable for revenue generation from biopharma partners and research institutions. Foresight Dx customers are biopharmaceutical companies or research institutions seeking precision oncology assays to evaluate MRD and a partner to execute diagnostic projects to enable regulatory filings. This individual also will monitor execution of some contracted work to ensure quality and provide a high level of customer satisfaction.
What You Will Bring:
Bachelor's Degree
Combined 5 years business development and sales experience selling a complex product or service
Previous experience in a healthcare products company (therapy, diagnostics or medical devices)
Proven track record in achieving company goals through creation of strategic partnerships, including pre-contract negotiations and post-contract alliance management.
Experience with the establishment of contracts, development of pricing strategies and monitoring contract fulfillment.
Preferred:
Bachelor’s Degree in a life sciences discipline
Master of Business Administration or a relevant life sciences PhD
Prior corporate development, tactical and/or strategic marketing experience
Previous experience in the companion diagnostics field or biopharma partnering
What You Will Do:
Lead business development for a portfolio of current and potential biopharma partners, including contract and in some cases alliance management activities for customers located potentially globally.
Create objectives and key results as well as account strategies needed to close revenue generating contracts for customers ranging from biopharma companies to research institutions.
Partner with marketing to support the voice of the customer for all marketing activities. Ensure strong handoff from marketing efforts to generate awareness in Foresight Dx and belief in Foresight Dx solutions to business development activities to reach and secure new customers.
Develop, maintain and execute a strong pipeline of new business and qualified leads.
Maintain a good understanding of the trends in the biopharmaceutical industry and how they impact the Foresight Dx and diagnostics broadly. Additionally, leverage these insights to support the strategic plan of the organization.
Follow emerging business trends and economic requirements of the biopharmaceutical industry as well as screen and recommend key target companies.
Work with project and lab personnel to ensure projects can be fully supported and delivered on quality and time.
Closely collaborate with all functions to align Foresight Dx biopharma partnership activities with the capabilities of the organization.
May manage staff as the business needs grow; provide staff with coaching, training, and opportunities to develop skills, and give ongoing, constructive and timely feedback on performance and progress toward goals and expectations.
Other duties as assigned by management.
This role is offering a salary between $210,000-240,000, and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is April 15, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Location: Hybrid (on site 3 days per week) in Boulder, Colorado, United States
About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role: As Foresight has reached new, exciting business milestones, we are starting to build out our Program Management Office (PMO). Foresight’s ideal candidate for the Program Manager role will have experience in both diagnostic program and/or product management and will collaborate cross functionally with internal stakeholders and external partners to deliver multiple projects simultaneously. The Program Manager will own, drive, communicate, and engage all project partners to enable accountability, problem solving, and on time delivery. To successfully execute at this level and with tight timelines, verbal communication and tool implementation, utilization, and management, paired with onsite presence (3 days a week) are critical to our shared success and our ability to deliver on Foresight’s mission.
This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. The Program Manager role reports into the SVP, Business and Laboratory Strategy & Operations.
For the ideal candidate needing to relocate for this position, Foresight may provide a sign on bonus to help cover your relocation costs.
What You Will Bring:
5+ years of experience in project/product management, with experience in biotechnology and clinical lab industries including direct experience delivering LDT and IVD products in FDA and CAP/CLIA regulated environments.
Program and product management experience supporting diagnostics, MRD experience preferred.
PMP or other project management certifications preferred.
Proven track record of successfully managing complex projects from initiation to closure and have led projects bringing products to market in a biotechnology environment (diagnostics product experience preferred).
Proficiency in project management tools and software.
Energy, motivation, and flexibility with excellent oral and written communication.
Situational awareness, coupled with facilitation, problem solving, and conflict resolution skills to drive cross-functional decision-making.
Familiarity with design control, translating user needs to product requirements, agile development, SWOT analysis, and product lifecycle management tools.
Ability to manage multiple projects and tasks concurrently with strong attention to timeline and performance metrics.
Demonstrated ability to work in a dynamic fast-paced environment, establish, and meet deadlines for product delivery.
Experience developing complex diagnostics including assay and software components.
Ability to think critically to overcome hurdles and devise solutions.
This position may be required to work across time zones as needed to support project schedules.
What You Will Do:
Technical
Lead project planning and execution, including scope, schedule, budget, and resource management and product design and development, ensuring processes are followed in accordance with regulations and general controls.
Develop project strategy and plans achieving buy-in from leadership and stakeholders.
Communicate project status, issues, and risks to senior leadership and stakeholders.
Ensure stakeholders/team members understand and adhere to project scope, coordinate on process development, implementation, and improvement, efficiently and effectively assess and remediate technical issues, and manage changes through defined change control protocols.
Facilitate and encourage collaboration across departments to ensure projects are completed successfully, within budget and on time.
Develop project and program management tools and
Conduct opportunity and risk management activities including identification, mitigation and realization for assigned projects/programs.
Coordinate with the SVP, Business and Laboratory Strategy & Operations and peers to develop and implement project management policies, procedures, and standards.
Identify opportunities for improvement in portfolio level processes, inform senior leadership of proposed solutions, and collaborate on implementation.
Team
Cultivate, build and maintain positive and collaborative relationships within teams and cross-functionally.
Partner with Alliance Management Team to ensure successful internal and external partner engagement and execution to delivery timelines.
Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific and performance standards.
Foster a culture of continuous improvement, identifying areas for process improvement and implementing changes as appropriate.
This role is offering a salary between $115,000-140,000, and is eligible for equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is April 1, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Boulder, Colorado area, Remote or Hybrid
Travel Required: Yes (% dependent on location, but >25%)
About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role: The Senior Manager, Alliance Management is responsible for managing active biopharma partnerships, contract execution, and is accountable for the customer experience of Foresight Dx’s biopharma and research institution partners. Foresight Dx customers are biopharmaceutical companies or research institutions seeking precision oncology assays to evaluate MRD and a partner to execute diagnostic projects to enable regulatory filings. This individual may also conduct business development activities with established partners to extend current programs or potentially contract new ones.
What You Will Bring:
Required Qualifications:
Bachelor's Degree
Minimum five years of combined alliance management and project/program management experience in an FDA-regulated healthcare product company (therapy, diagnostics, or medical devices).
Demonstrated leadership of cross-functional teams.
Proven track record in achieving company goals from the initiation of biopharma partnerships through the rest of the contract term.
Experience with legal agreements and contracts, as well as monitoring contract fulfillment.
Preferred Qualifications:
Bachelor’s Degree in a life sciences discipline
Master of Business Administration or a relevant life sciences MS or PhD
Previous experience in the companion diagnostics field or biopharma partnering.
What You Will Do:
Manage biopharma collaborations as the primary point of contact for partners and as the bridge to Foresight Dx’s internal project teams and leadership.
Guide internal project teams with respect to opportunities and constraints arising from the partnership agreements; ensure project aims, deliverables, and objectives are met.
Establish and facilitate stage-appropriate governance systems, including steering and operational committees and decision-making processes.
Monitor and track compliance with contractual obligations, such as development timelines, research updates, committee meetings, and milestone payments.
Lead launch of new partnerships to include pre-deal considerations, transitions to an active contract, or end of a partnership as appropriate.
Proactively identify and problem-solve issues and risks, conduct health checks, and identify opportunities to improve, expand, or redirect the partnership.
Participate in biopharma discussions and negotiations for new partnering agreements with Business Development.
Serve as the owner of Alliance Management business processes to improve capabilities and, drive efficiencies, document best practices where appropriate.
Maintain a good understanding of the trends in the biopharmaceutical industry and how they impact the Foresight Dx and diagnostics broadly. Additionally, leverage these insights to support the strategic plan of the organization.
Works with project and lab personnel to ensure projects are fully supported and delivered on quality and time.
Closely collaborate with all functions to align Foresight Dx biopharma partnership activities with the organization's capabilities.
May manage staff as the business needs grow; provide staff with coaching, training, and opportunities to develop skills; and give ongoing, constructive, and timely feedback on performance and progress toward goals and expectations.
Other duties as assigned by management.
Applications for this role must be received by May 10, 2024.
This role is offering a salary between $140,000-$183,000, generous equity, along with medical, dental and vision benefits. You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Location: On site or hybrid schedule in Boulder, Colorado, United States
About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Role: The Senior Manager, Quality Assurance will be responsible for establishing and maintaining quality processes and improvement initiatives for FDA and ISO-regulated products and clinical testing, specifically supporting Foresight’s GCP/CLIA laboratory. This role will operationalize quality systems, leveraging your technical knowledge, skill and abilities to ensure regulatory compliance. The Senior Manager, Quality Assurance will also manage internal and external communication with regulatory agencies overseeing the clinical laboratory and ensuring all applications, systems, products and procedures meet defined quality standards. This position will report to the Director of Quality.
What You Will Bring:
Bachelor’s degree in a scientific field
Minimum of 7 years of experience in an FDA/ISO-regulated environment, including experience with Clinical regulations (CAP/CLIA/NYSDOH for high-complexity laboratory testing)
Ability to define, scope, map and implement new or improved documented quality processes
Knowledge of BSL-2 laboratories
Experience with LIMS, eQMS, and paper-based quality systems
Excellent verbal and written communication skills, as well as attention to detail and organizational skills
What You Will Do:
Implement and maintain the necessary programs to support the Quality Policy, the Quality System, and continuous improvement initiatives to ensure compliance with ISO15189, FDA GCP and GLP, CAP/CLIA, NYSDOH, and other US and international regulatory standards.
Ensure that Quality System elements are in compliance with Clinical, ISO, and FDA regulations, and help to create and/or drive improvements to Policies and Standard Operating Procedures.
Oversee FDA-regulated design control activities to ensure effective and compliant execution for the Foresight assay and software design.
Manage design control documentation required for effective DHF/DHR/DMR management.
Organize and lead the management of NCR/CAPA, complaints, management review, laboratory support, services, processes, reporting, supplier management, document and records control, training, audits, and other QMS responsibilities.
Define and maintain quality metrics to measure, analyze, and implement processes to monitor and improve quality.
Identify and evaluate issues and/or gaps in processes and documentation, and propose effective solutions to remediate.
Host and provide front-room representation during internal and external audits, including CAP, FDA, ISO, and biopharmaceutical companies.
Manage audit program, including schedule adherence, reviewing audit reports, and following up on required actions.
Maintain the eQMS and provide document control support.
Team
Communicate and interact with all levels of the organization including Executive Leadership
Work effectively with cross-functional teams for problem-solving, product and process improvement
Cultivate, build and maintain positive and collaborative relationships within the Quality team and cross-functionally
Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific, and performance standards to ensure the highest quality for sample integrity
Leverage leadership skills to motivate, inspire and train staff to engage in quality and adhere to regulations
This role is offering a salary between $155,000-169,000 and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is April 5, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Remote, Boulder Colorado, United States
About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About the Quality Team: Come join a growing Quality team that is eager to incorporate Quality principles into the framework of an entire organization! We are building intuitive compliance systems needed to ensure that regulatory requirements are met while helping to ensure the scalability of our operations.
About the Role: The Software Quality Engineer will be responsible for ensuring software systems supporting cross functional teams and Foresight’s products are developed, implemented and maintained in compliance with ISO27001, IEC62304, ISO13485, and clinical regulations (CAP, CLIA, ISO15189). This position will work cross functionally with internal members of the clinical laboratory, R&D, IVD, bioinformatics, product development, and regulatory teams predominantly on software quality requirements, but may also be asked to participate in additional QMS activities to support cross-functional projects and requirements. Externally, this position will participate in audits with our regulatory bodies. This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Director of Quality.
What You Will Bring:
3-5 years of experience working in a software quality-related role in a regulated environment, such as FDA, ISO, or CAP/CLIA
Bachelor’s degree in software engineering, computer science, information technology, or related.
Experience executing IEC62304 software design lifecycle development in conjunction with ISO13485 design control requirements
Experience defining process requirements for, and conducting, software validation
Demonstrated ability to verify software test execution (automation and manual)
Proven ability to deliver actionable results to complex problems
Ability to deliver on end-to-end projects with a high level of autonomy
Exceptional interpersonal skills with ability to work inclusively and collaboratively with a diverse population
What You Will Do:
Develop and implement comprehensive test plans and test cases to assess compliance of products outlined in the product roadmap and coordinate with cross functional teams on timely remediation
Execute test plans, automated and manual, to confirm quality conformance to predefined specifications and quality deliverables, and present associated documentation/reports to cross functional teams and leadership for review
Lead cross functional collaboration in designing and implementing validation plans for Foresight’s suite of software systems
Create and revise standard operating procedures (SOPs), as needed, to define software quality requirements and release readiness operations, and shepherd these documents through the design and documentation control processes
Develop risk analysis tools and risk management plans for Foresight’s suite of software systems
Closely monitor, maintain, and improve the efficiency of processes via regular audits and internal reporting
Resolve end user issues via investigation and resolution, to include management of the NCR and CAPA processes and metrics
Ensure all software quality practices are in compliance with Foresight’s SOPs and applicable regulations
This role is offering a salary between $112,000-135,000 and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is May 15, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.