Program Director

Job Overview:

Key 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.

Preferred Qualifications

• 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.