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.
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.
Location: 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 Vice President of Human Resources will be responsible for leading and managing the overall HR function for the company. This includes developing and implementing strategic HR initiatives, creating and implementing policies and procedures, and managing the recruitment and selection process for all positions within the company. The Vice President of Human Resources will act as a strategic business partner to the senior leadership team, providing guidance and support on all HR-related matters. The Vice President of Human Resources will be responsible for creating and maintaining a positive and productive work environment in alignment with the company’s culture that promotes employee engagement, retention, and satisfaction. In addition, the Vice President of Human Resources will contribute as a corporate leader of the company, engaging in strategic planning, execution, evaluation and communication of corporate initiatives. This position reports directly to the Chief Operating and Compliance Officer.
What You Will Bring:
Bachelor's degree in human resources management or a related field; legal experience is a plus.
A minimum of 8-10 years of experience in human resources management, with at least 5 years of experience in a senior-level HR role.
Proven track record of successfully leading and managing the HR function in start up organizations, health care or biotech industry preferred.
Strong knowledge of federal, state, and local labor laws.
Excellent communication, leadership, and interpersonal skills.
SPHR or SHRM-SCP certification is a plus.
Project management and change management skills.
Excellent analytical, data interpretation and problem solving skills.
Business acumen, financial literacy, and clear understanding of effective business operations.
Experience in employee relations, compliance, recruitment, and employee development are essential.
What You Will Do:
Support the overall strategic goals and objectives of the company by aligning HR initiatives with the company's mission, vision, and values.
Attract, hire, and retain top talent for the company. This includes developing and implementing effective recruitment and selection processes, as well as creating and maintaining a positive and productive work environment in alignment with the company’s culture that promotes employee engagement, retention, and satisfaction.
Improving employee performance and productivity by managing the performance management process, including goal setting, performance evaluations, and career development plans.
Supporting employee development and growth by implementing and managing employee training and development programs, including onboarding, employee orientation, and ongoing professional development.
Coordinate external and develop internal leadership training programs to support continuing education for senior and functional leadership.
Managing and controlling the HR budget, including forecasting, tracking, and reporting on HR expenses.
Ensuring compliance with federal, state, and local labor laws, including providing guidance on immigration, worker's compensation, and other HR-related laws.
Managing and resolving complex employee relations issues, investigations, and complaints.
Collaborating with senior leaders and other stakeholders to identify and address organizational development needs, including succession planning and talent management.
Developing and implementing employee engagement and recognition programs to increase employee satisfaction and retention.
Conducting research and providing data analysis on industry best practices and trends to inform and drive HR strategy and decision-making.
Collaborate with local partners, such as the University system to develop internship programs and successful academic to industry transitions for entry level talent.
Act as a strategic partner to the COO and other senior leaders, providing guidance and support on all HR-related matters.
Continuously monitor and improve HR processes, procedures and policies to ensure they are in line with the company's goals and objectives.
Develop, implement and track HR KPIs for Corporate Operations monthly reporting.
Manage and develop the HR team.
Contribute to leadership of the organization, including strategic planning, decision making, and execution of critical corporate objectives.
This role is offering a salary between $215,000-260,000 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.