CorDx
Overview
CorDx is a multinational biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Job Details
Job Type: Full time
Job Title: Program Director
Location: Onsite - Atlanta/San Diego
Responsibilities
Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch
Develop and manage detailed program plans, timelines, budgets, and resource allocation
Serve as the primary point of contact for program status, risk assessment, and issue resolution
Drive strategic alignment across stakeholders and ensure program goals are met in accordance with company objectives
Track key milestones and prepare executive-level reporting on program performance and progress
Facilitate effective communication across internal teams, senior leadership, and external partners
Ensure programs meet regulatory requirements (e.g., FDA, ISO 13485) and support submission readiness
Manage program governance, including steering committee meetings and stage gate reviews
Identify risks and proactively implement mitigation strategies to ensure timelines and deliverables are met
Qualifications
Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree (MS, PhD, or MBA) preferred
8-10+ years of experience in the biotech, diagnostics, or medical device industry, with a focus on IVD product development
5+ years of program/project management experience in a regulated environment
Strong knowledge of regulatory pathways, quality systems (e.g., ISO 13485), and clinical development for IVDs
Proven ability to lead cross-functional teams and manage complex programs with multiple stakeholders
Life Science/ IVD industry experience preferred
PMP certification or formal training in project/program management strongly preferred
Excellent communication, leadership, and organizational skills
Comfortable in a fast-paced organization with evolving priorities
Preferred Skills & Competencies
Experience with global product launches and managing distributed teams
Familiarity with Agile and/or Stage-Gate development methodologies
Prior experience working with external partners and managing outsourced development/manufacturing
Strong problem-solving skills and business acumen
Benefits
Comprehensive medical, dental, and vision insurance
401(k) plan with generous company contributions
Flexible paid time off (PTO) policy
Additional substantial benefits
Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
#J-18808-Ljbffr
Job Details
Job Type: Full time
Job Title: Program Director
Location: Onsite - Atlanta/San Diego
Responsibilities
Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch
Develop and manage detailed program plans, timelines, budgets, and resource allocation
Serve as the primary point of contact for program status, risk assessment, and issue resolution
Drive strategic alignment across stakeholders and ensure program goals are met in accordance with company objectives
Track key milestones and prepare executive-level reporting on program performance and progress
Facilitate effective communication across internal teams, senior leadership, and external partners
Ensure programs meet regulatory requirements (e.g., FDA, ISO 13485) and support submission readiness
Manage program governance, including steering committee meetings and stage gate reviews
Identify risks and proactively implement mitigation strategies to ensure timelines and deliverables are met
Qualifications
Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree (MS, PhD, or MBA) preferred
8-10+ years of experience in the biotech, diagnostics, or medical device industry, with a focus on IVD product development
5+ years of program/project management experience in a regulated environment
Strong knowledge of regulatory pathways, quality systems (e.g., ISO 13485), and clinical development for IVDs
Proven ability to lead cross-functional teams and manage complex programs with multiple stakeholders
Life Science/ IVD industry experience preferred
PMP certification or formal training in project/program management strongly preferred
Excellent communication, leadership, and organizational skills
Comfortable in a fast-paced organization with evolving priorities
Preferred Skills & Competencies
Experience with global product launches and managing distributed teams
Familiarity with Agile and/or Stage-Gate development methodologies
Prior experience working with external partners and managing outsourced development/manufacturing
Strong problem-solving skills and business acumen
Benefits
Comprehensive medical, dental, and vision insurance
401(k) plan with generous company contributions
Flexible paid time off (PTO) policy
Additional substantial benefits
Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
#J-18808-Ljbffr