Senior Director, Project/Program Management

About the Role

Reporting to the Executive Director of Program Management, the Senior Director of Program Management will be responsible and accountable for the coordination and leadership of activities associated with advancing novel Neurology and Other Rare Disease gene therapy programs through late-stage clinical development, regulatory approval, and into commercial launch. While the primary focus of this role is late-stage development — spanning pivotal trials, regulatory submission, and launch readiness — the individual may also provide program management support to earlier-stage programs within the gene therapy portfolio as needs evolve.

The Sr. Director of Program Management will serve as the operational COO for the Global Program Team (GPT), utilizing best-in-class program management capabilities to provide end-to-end oversight of program strategy and execution — including initiating, planning, executing, controlling, reporting, and closing integrated Program and Functional development plans across the Neurology and Rare Disease therapeutic area.

As a senior operational leader, the Sr. Director of PM will provide cross-functional operational and program management leadership, strategic thinking, and business acumen for late-stage gene therapy programs in a matrixed R&D organization. This individual will bring a commercialization mindset to development planning, ensuring that regulatory strategy, market access, and launch readiness are integrated into the program from the outset of late-stage development. Additionally, the Sr. Director of PM will work with the PM team and global organization to design and refine processes and business structures, recommending solutions that drive process standardization and simplification across the company.

What You'll Do

In this role, you will serve as the operational COO for the Global Program Team (GPT), partnering with the GPT Head to drive strategy execution, align cross-functional priorities, and ensure the program team operates with clarity, accountability, and urgency through pivotal trials, regulatory submission, approval, and commercial launch. You will also have responsibility for:

• Late-Stage Program Execution: Lead and direct integrated, cross-functional program teams to plan, execute, control, and report on all program-related activities — including integrated program budget, risk, timelines, resource management, and stakeholder communication — across late-stage clinical development through approval and launch.
• Integrated Planning & Documentation: Drive the development and maintenance of key program documentation including Target Product Profiles (TPPs), Integrated Development Plans (IDPs), Regulatory Strategy Roadmaps, Launch Readiness Plans, Risk Registers, and integrated program dashboards; ensure these tools reflect a clear, executable path to approval and launch for gene therapy programs in neurology and rare disease.
• Risk & Scenario Management: Lead scenario planning, risk management, and contingency planning across late-stage development, with particular attention to gene therapy-specific risks including vector manufacturing scalability, batch release timelines, immunogenicity, long-term follow-up requirements, and regulatory agency interactions (FDA, EMA).
• Cross-Functional Alignment & Governance: Ensure alignment between the GPT, functional teams, and portfolio plans such that program milestones, resource allocations, and investment decisions are tracked, communicated, and managed with rigor. Surface trade-offs and recommendations to senior leadership proactively.
• Launch Readiness: Integrate a commercialization lens throughout late-stage development planning; coordinate across Program Management, Regulatory Affairs, Medical Affairs, Market Access, Commercial, and Supply Chain to drive launch readiness milestones and ensure a seamless transition from regulatory approval to commercial availability.
• Executive Communication: Own and drive proactive, clear communication across the GPT and to senior leadership on program status, decisions required, issues, risks, and opportunities; prepare executive updates, portfolio reviews, and governance submissions.
• Regulatory Strategy Support: Partner with Regulatory Affairs to shape and execute regulatory strategy for rare disease gene therapy programs, including interactions with health authorities on Breakthrough Therapy Designation, Accelerated Approval, Orphan Drug Designation, and other expedited pathways.
• PMO Excellence: Contribute to the success of the Program Management Organization (PMO) by ensuring program work is conducted in compliance with PMO processes and Company policies; lead continuous improvement initiatives specific to late-stage gene therapy program delivery.
• Mentorship & Talent Development: Mentor and develop junior program management professionals within the PM organization; share expertise in late-stage development, gene therapy program management, and operational excellence to build team capability.

Who You Are

You have a Bachelor’s degree in a scientific or medical discipline required. An advanced/post-graduate degree (Ph.D., Pharm.D., M.D., or M.S.) is a distinct advantage, particularly in a field relevant to gene therapy, neurology, rare disease, or molecular biology. 12+ years of Program/Project Management experience with proven leadership experience in late-stage Research and Development within a biotech/biopharmaceutical environment, including direct accountability for programs in pivotal trials, regulatory submission, and/or launch.

Additionally, you are or you have:

• Gene Therapy or Biologics Expertise (Required): Demonstrated hands-on experience in gene therapy (viral vector-based — AAV, lentiviral, or similar) or biologics (monoclonal antibodies, fusion proteins, enzyme replacement therapies, or other large-molecule modalities). Candidates must have working knowledge of the unique scientific, manufacturing, and regulatory challenges associated with these modalities. Gene therapy experience is strongly preferred.
• Commercial Launch Experience (Required): Must have directly supported or led at least one successful commercial product launch, with experience coordinating across program management, regulatory affairs, medical affairs, market access, and supply chain to achieve launch readiness milestones.
• Mentoring Experience (Required): Must have prior formal experience mentoring junior program management professionals; demonstrated ability to coach and develop talent in a matrixed environment.
• Rare Disease / Neurology Expertise: Neurology or Rare Disease experience is highly preferred, including familiarity with the regulatory landscape for rare diseases (e.g., Orphan Drug Designation, Breakthrough Therapy, Accelerated Approval pathways).
• Strong scientific acumen with direct experience in gene therapy or biologic drug development; ability to engage credibly with scientific, clinical, regulatory, and commercial teams on complex, cross-functional topics.
• Demonstrated ability to serve as an operational leader (COO function) for a cross-functional program team — setting agendas, driving decisions, resolving conflicts, and keeping large, complex programs on track.
• Strong interpersonal skills with the ability to influence without authority, motivate with enthusiasm, and develop productive working relationships with key stakeholders across R&D, Regulatory, Medical Affairs, Commercial, and Executive Leadership.
• Entrepreneurial, self-starter with a proven track record of success in a fast-paced, demanding environment; results-oriented work ethic with a positive, can-do attitude.
• Well-developed computer skills (e.g., MS Project, Excel, PowerPoint, SharePoint, Veeva, or equivalent program management tools).
• Project Management Professional (PMP) certification is a plus, but not required.

Travel Requirements

This role requires domestic and/or international travel of approximately 20- 30% based on business needs.

Where You’ll Work

This is a hybrid role based out of our San Diego, CA office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most.