Director, Diagnostic and Clinical Software Systems

About Akoya Biosciences, Inc.

As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler®, PhenoImager® Fusion, and PhenoImager HT Instruments.

Job Description Summary

Akoya is seeking a Senior Director, Diagnostic and Clinical Software Systems, primarily working remotely, with occasional travel to our offices in Marlborough, MA. The senior director will leverage previous experience leading the development of diagnostic and clinical software system solutions to support the rapid demands for new products across Akoya’s clinical portfolio, leveraging their technical background, industry knowledge, clinical laboratory experience, project leadership, and business acumen. This person will partner with key internal and external stakeholders to define, deliver, and maintain the software systems, driving technological transformation throughout the software lifecycle.

Duties and Responsibilities

• Architect for complex clinical software system development projects, cross-program, and cross-project architecture strategies, opportunities, and problem resolution

• Advisor to senior business management on clinical laboratory systems and integration strategies

• Translates and maps business strategy into platform implementation strategy including translation of complex or ambiguous business problem statements into clear requirements

• Ensures Akoya software requirements and solutions consider the voice of the customer

• Lead and set priorities for the software engineering and test teams

• Comfortable working as part of a multi-functional, geographically distributed team, and is prepared to work to bold timelines along iterative development schedules

• Ensures that all systems are designed, developed, tested and maintained to ensure compliance with internal policies and external regulations (e.g. CAP/CLIA, FDA, CE-IVD)

• Accountable for system software requirements, working in collaboration with Systems Engineering team to ensure all user requirements are accounted for

• Drives external partner deliverables, ensuring quality and execution to internal and industry standards

• Maintains clear project focus and works effectively with project managers, management team, internal stakeholders, regulatory, customers, and vendors to attain project goals and objectives

• Facilitate the transition of product design and enhancements to full production/delivery using Agile/SCRUM development methodologies

• Performs technology due diligence on platform development and architecture topics, including open-source software solutions

• Works closely with business partners to identify and maximize opportunities to use information and technology to improve product, service and/or business processes

• Collaborate with vendors and subject matter experts to establish the technical vision and analyze tradeoffs between usability and performance needs

• Collaborates with the laboratory and with software testing team members performing computer systems verification to define, develop and implement quality assurance test practices and procedures for project implementation and ongoing support

• Other duties as assigned

Qualifications/Skills

• Master’s degree in business administration, computer science, healthcare administration, or a related field and or the equivalent combination of education, experience and/or training

• Minimum 10 years leadership experience in software or platform development roles, with increasing levels of responsibilities

• Minimum 10 years in life sciences industry implementing and/or supporting validated systems for CAP/CLIA and GxP compliance, including multiple LIMS implementations

• Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders

• Prior experience integrating clinical software systems consisting of various regulatory classifications and environments (e.g. CAP/CLIA, FDA, CE-IVD)

• Prior experience collaborating with and coordinating activities with outsource development partners

• Strong analytical interpretation skills required to interpret customer business needs and pain points, to define and translate into a software solution to meet needs

• Self-starter with ability to successfully engage in multiple initiatives simultaneously

• Experience leading teams that have a mix of full-time employees and utilization of third-party development partners

• Experience with building clinical software platforms that include immunohistochemical or immunofluorescent imaging and diagnostic image analysis algorithms preferred

• Excellent business process analysis skills to assess user requirements against system capabilities to create design documentation for business communication and technical development

• Ability to work well in a team as well as independently to accomplish tasks without supervision

The hiring range for this position is $187,000 - $240,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Akoya’s excellent benefits program includes a selection of Medical and Dental plans, and Life, AD&D and Short-Term Disability insurance, Tuition Reimbursement, 401(k) with immediate Company match vesting, Company paid holidays and more!

Akoya values bringing together individuals with diverse backgrounds. We are proud to be an Equal Opportunity/Affirmative Action Employer. We do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.