Sr. Program Director - Regulatory and Clinical Development

The Senior Program Director, Regulatory & Clinical Development has strategic, company and project level responsibilities focusing on transformation and execution. This leader is accountable for shaping and executing the program/portfolio strategy and ensuring operational excellence across clinical programs at Akero.

Reporting to the Vice President, Regulatory Affairs.

The position will interact with all areas of Clinical and Regulatory Affair. In addition, clinical within Novo Nordisk.  The position interacts with team members at the IC through Vice President level.  The position requires experience interacting with senior level positions in each of these departments and a good understanding of how these peer teams operate, ideally through experience working within these teams (broad experience).

Externally, the position will engage with CROs and CMOs

Job 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.

Qualifications

• 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 
  • Preferred experience working with Phase III trials for liver indications 
• 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.
• Knowledgeable about lab-engineered analogs highly preferred 

The base compensation range for this position is $181,670 to $317,920. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.  

Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors.  

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

The job posting is anticipated to close on February 28, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities.

EEO Statement:

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.