Cordx
Program Director
Atlanta, Georgia, United States · Director · Full-time
Sponsorship not specifiedDetected 424 days ago
Data ScienceComplianceProject ManagementFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs
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Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- This role will oversee complex product development initiatives from concept through commercialization, ensuring alignment with strategic objectives, regulatory compliance, and time/cost constraints.
- The ideal candidate will have a strong background in project/program management, deep understanding of the biotech/IVD landscape, and a proven track record in delivering results through collaboration and leadership.
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.
- Drive strategic alignment across stakeholders and ensure program goals are met in accordance with company objectives.
- 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.
Requirements
- 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.
Nice to have
- Bachelor's degree in Life Sciences, Engineering, or a related field
- advanced degree (MS, PhD, or MBA) preferred.
- Life Science/ IVD industry experience preferred.
- PMP certification or formal training in project/program management strongly preferred.
- Preferred Skills & Competencies: Experience with global product launches and managing distributed teams.
Skills
- Experience with global product launches and managing distributed teams.
- Familiarity with Agile and/or Stage-Gate development methodologies.
- Strong problem-solving skills and business acumen.
- 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:
Benefits
- Who is CorDx CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health.
- 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.
Company info
- Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity.
- We are seeking a highly skilled and experienced Program Director to lead cross-functional programs within our In Vitro Diagnostics (IVD) and broader diagnostics portfolio.
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.
This listing is sourced directly from Cordx's careers page and normalized into a canonical job model.