Program Director
2 days ago
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OnsiteFull-timeSenior
Summary
CorDx is seeking a Program Director to join their team in Atlanta/San Diego. The role involves leading cross-functional programs within their In Vitro Diagnostics (IVD) and broader diagnostics portfolio, overseeing complex product development initiatives from concept through commercialization.
About the Role
As a Program Director, you will lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch. You will 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, and ensure programs meet regulatory requirements. Additionally, you will track key milestones, prepare executive-level reporting, and facilitate effective communication across teams and stakeholders.
About You
Required:
- 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.
- Excellent communication, leadership, and organizational skills.
Preferred:
- 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.
CorDx
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease 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. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Atlanta, GA