Sr. Program Director - Regulatory and Clinical Development

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing treatments for serious metabolic diseases. The Senior Program Director, Regulatory & Clinical Development is responsible for shaping and executing program strategies, ensuring operational excellence across clinical programs, and leading cross-functional alignment to meet strategic priorities.

Responsibilities:

• Own and execute program and portfolio management strategy across Akero’s development organization
• Serve as primary cross functional integrator, ensuring alignment between strategy, execution, governance and decision making across programs
• Partner with Development Therapeutic Area VPs and senior leaders to advance strategic priorities and ensure clear accountability, ownership, and decision rights
• Design, implement, and run Akero’s development governance model in alignment with the parent organization
• Establish and maintain decision-making frameworks, escalation pathways, and executive visibility into risks, trade-offs, dependencies, and outcomes
• Lead Akero Development governance meetings and ensure consistent alignment with parent company processes and expectations
• Collaborate with TechOps (CMC) to develop, gain approval, and execute on the project strategy in alignment with parent company
• Lead cross-functional alignment across departments, proactively identifying and resolving risks, conflicts, and misalignments
• Oversee program timelines, integrated development plans, and delivery of key milestones across the portfolio
• Manage trade-offs and dependencies, escalating issues to senior leadership as needed to maintain progress and alignment
• Identify gaps in capabilities, training, and processes (e.g., GCP training), and partner with Quality to support compliance activities as needed
• Establish scalable systems, templates, tools, and best practices for program and portfolio management
• Own portfolio-level risk and issue management, ensuring mitigation strategies are proactively developed and executed
• Monitor program performance and intervene as needed to keep programs on track
• Partner with Finance and leadership on development budgets, forecasting, and resource allocation across the portfolio
• Build, mentor, and develop program management talent
• Organize and deploy project management support across functional areas and programs
• Foster a high-performing, accountable, and collaborative program management culture

Requirements:

• Minimum of a bachelor's degree required, advanced degree (master's or PhD preferred), preferably within a scientific discipline or other related fields
• 15+ years of proven experience in biotech / pharma portfolio and project management at a strategic and operational level
• Demonstrated ability to lead transformation initiatives and drive organizational change
• Strong financial acumen and experience with budget ownership and planning
• Expertise in governance frameworks and decision-making processes
• Track record of building and developing high-performing teams
• Excellent communication, stakeholder management, and cross-functional leadership skills
• Preferred experience working with Phase III trials for liver indications
• Knowledgeable about lab-engineered analogs highly preferred