Program Management - Late-Stage Development

About the role

Join a team leading late-stage drug development programs across therapeutic areas, including eye care, with a focus on advancing products through clinical trials, regulatory submission, and launch.

Responsibilities

• Develop and execute cross-functional program strategies and integrated plans with Program and Core Teams.
• Establish and maintain comprehensive program timelines covering clinical, regulatory, manufacturing, quality, and commercial activities.
• Lead planning and coordination for pivotal trial execution, database lock, and regulatory filings.
• Drive regulatory submission planning and ensure timely, high-quality filings in collaboration with Regulatory Affairs.
• Support launch readiness by coordinating across multiple functions and developing risk mitigation strategies.
• Facilitate meetings, document decisions, and maintain strong stakeholder relationships.
• Manage program budgets, resources, and track spend against forecasts.
• Serve as a subject matter expert in program management, promoting best practices and continuous improvement.

Qualifications

• 8+ years in biotech/pharmaceutical product development, with at least 5+ years in project/program management.
• Experience managing drug development from preclinical to Phase III, including pivotal trials, regulatory submissions, and product launch.
• Bachelor’s degree in a related field; advanced degrees are a plus.

Skills

• Knowledge of drug development processes, GxP/ICH guidelines, and health authority interactions.
• Proficiency with project management tools and strong leadership, communication, and stakeholder management skills.
• Problem-solving ability, adaptability, and a results-oriented mindset.

Benefits

Comprehensive benefits focused on work-life balance.

Pay

Competitive salary, bonus, stock options.

Additional Details

• Based in an office with hybrid work options, promoting a culture of innovation, teamwork, and patient focus.
• Role involves some travel (up to 10%).