Head of Product Launch Program Management (Rare Disease)

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.

Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders.

More information can be found at rezolutebio.com

The Director, Product Launch Program Management is a member of the Program Management Office (PMO), reporting to the Senior Vice President, Operations, and directly supporting the Commercial Product Launch Lead (Head of Marketing). The PLPM owns the integrated launch plan by indication and by market across the U.S. and priority ex-U.S. countries, and facilitates, consolidates, organizes, documents, and measures that plan so the Product Launch Lead and functional leaders can make decisions and deliver against it. The role supports establishment of the launch strategy with specific responsibility to make it complete, current, and executable. Working within the company’s governance model, the role works daily within the PMO enabling coordination, dependency determination, awareness and cross functional planning with program managers supporting the Development and Technical Operations teams.

Success requires a working understanding of each contributing function’s scope of work, with emphasis on critical coordination of Commercial, Regulatory, Medical Affairs, Supply and Quality, and the ability to engage the working team credibly on scope, tasks, dependencies, risks, and outcomes. As Rezolute advances concurrent launches across multiple indications in the U.S. and ex-U.S., this role may expand to build and manage a team of Launch Program Managers.

This can be a remote role based in the United States, with travel as necessary to Rezolute headquarters in Redwood City, CA, and to launch team, partner, and ex-U.S. working sessions.

Key Responsibilities : Launch Plan Ownership

• Own a s ingle, authoritative integrated l aunch plan (ILP) by indication and by market, covering scope, tasks, owners, timelines, critical path, and cross-functional dependencies, including shared versus indication-specific workstreams.

• Consolidate inputs from Commercial, Market Access, Medical Affairs, Regulatory, Clinical, Manufacturing, Quality, Supply Chain, Finance, and Legal, and reconcile conflicts in timing, assumptions, and ownership.

• Manage plan changes through PMO governance , re-baselining when scope, indication sequencing, or timing changes and communicating impacts to the team.

Facilitation & Day-to-Day Coordination

• Facilitate launch team and working team meetings on behalf of the Head of Operations and/or Product Launch Lead, driving agendas and pre-reads to document decisions, actions, and owners hip .

• Work s d ai ly with amongst the launch working team to communicate, coordinate, influence , problem solve and drive issue resolution ; escalate critical-path issues, dependencies and risks in a timely way , with options.

• Coordinate Launch Readiness Reviews (LRR) and day-of-approval and launch-window execution plans, and capture lessons learned for subsequent indication and country launches.

• Assemble, facilitate , coordinate , manage and document cross functional sub teams driving alignment .

• Support Head of Operations, Executive Leadership and enterprise functions including IS&T.

Documentation, Measurement & Reporting

• Maintain the launch plan record set, including RACI, decision log, risk and issue register, and change log, so the current state of each launch is always clear.

• Develop and maintain readiness criteria, dashboards, and KPIs by indication and market; track variance to baseline; and report status to the Product Launch Lead, the Head of Operations, the enterprise PMO, and executive and Board forums.

U.S. & Ex-U.S. Market Entry

• Maintain country-level plans for priority ex-U.S. markets with regional leads, distributors, and partners, tracking regulatory, pricing and reimbursement (HTA), supply, and market-entry milestones.

• Work with the Development team Program Manager to i ntegrate Expanded Access Program (EAP) and ex-U.S. Named Patient Pr ogram (NPP) activities, enabling to internal and external coordination toward NPP sales , and the transition of clinical trial, open-label extension, EAP, and NPP patients to commercial supply in each market.

Team Leadership (as the launch portfolio expands)

• Build, lead, and develop a team of Launch Program Managers supporting concurrent U.S. and ex-U.S. launches, and establish common PMO standards, tools, and templates.

Qualifications : Education

• Bachelor’s degree required ; advanced degree (MBA, MS, PharmD, or PhD ) preferred.

Experience

• 7+ years in a similar role with broad program management responsibility for a biotech therapeutic; rare disease strongly preferred.

• Hands-on ownership of an integrated launch plan (ILP) through at least one product launch, from approximately 24 months before approval through post-launch; concurrent, multi-indication, first-in-company, or biologic launch experience preferred.

• Familiarity with ex-U.S. Named Patient Program sales, Expanded Access Programs, and ex-U.S. distribution or partnered market entry (e.g., distributor or licensing-partner models).

• Experience managing or mentoring program managers preferred.

• Proficiency with Smartsheet, MS Project, or equivalent tools; PMP or related certification a plus .

Functional Knowledge

Working knowledge of the launch scope of work for:

• Commercial: marketing, market access, pricing, trade and distribution, patient services, data warehousing and commercial operations, and field readiness

• Medical Affairs: medical strategy, scientific communications, medical information, field medical, and evidence generation

• Supply and Quality : commercial supply readiness, demand and supply planning, packaging and labeling, and distribution ; compliance, inspection readiness, QMS and Quality integration across all GxP functions, plans and activity

• Regulatory: rare-disease pathways (e.g., Orphan Drug Designation, Breakthrough Therapy, Priority Review, PRIME, conditional approval) and how regulatory milestones drive launch timing

Competencies

The successful candidate will demonstrate:

• Plan ownership: Organized and disciplined; keeps the plan, records, and status accurate and current.

• Functional credibility: Engages function leads and task owners on scope, tasks, dependencies, risks, and outcomes based on experience and specific understanding of their work.

• Communication and influence: Clear in writing and in the room, from the working team to executive and Board audiences; influences without authority as a service-oriented partner to the Product Launch Lead and functional leaders.

• Resolution and escalation: Resolves issues and solves problems at the working level; escalates early, with facts and options.

• Remote effectiveness: Self-directed across time zones; willing and able to travel as necessary, including internationally.

• Direct multi-tasked execution and ownership: comfort working within a fast paced, agile, hands on environment