Head of Product Launch Program Management (Rare Disease)

Rezolute • Redwood City, CA

20d • Remote

About The Position

Rezolute is seeking a Director, Product Launch Program Management to join its Program Management Office (PMO). Reporting to the Senior Vice President, Operations and directly supporting the Commercial Product Launch Lead (Head of Marketing), this role owns the integrated launch plan by indication and market across the U.S. and priority ex-U.S. countries. The position makes the plan complete, current, measurable, and executable so launch leadership and functional teams can make decisions and deliver against it.

The role works within the company’s governance model and coordinates daily with the PMO and program managers supporting Development and Technical Operations. It requires a working understanding of contributing functions’ responsibilities and credible engagement with teams on scope, tasks, dependencies, risks, and outcomes, particularly across Commercial, Regulatory, Medical Affairs, Supply, and Quality. As Rezolute advances concurrent launches across indications and markets, the 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, California, and to launch-team, partner, and ex-U.S. working sessions.

Requirements

• Bachelor’s degree.
• At least 7 years in a similar role with broad program-management responsibility for a biotech therapeutic.
• Hands-on ownership of an integrated launch plan through at least one product launch, from approximately 24 months before approval through post-launch.
• Familiarity with ex-U.S. Named Patient Program sales, Expanded Access Programs, and ex-U.S. distribution or partnered market entry, such as distributor or licensing-partner models.
• Proficiency with Smartsheet, MS Project, or equivalent tools.
• Working knowledge of launch scope across Commercial functions, including marketing, market access, pricing, trade and distribution, patient services, data warehousing and commercial operations, and field readiness.
• Working knowledge of Medical Affairs scope, including medical strategy, scientific communications, medical information, field medical, and evidence generation.
• Working knowledge of Supply and Quality scope, including commercial supply readiness, demand and supply planning, packaging and labeling, distribution, compliance, inspection readiness, QMS, and Quality integration across GxP functions, plans, and activities.
• Working knowledge of Regulatory scope, including rare-disease pathways such as Orphan Drug Designation, Breakthrough Therapy, Priority Review, PRIME, and conditional approval, and how regulatory milestones drive launch timing.
• Organized and disciplined approach to maintaining accurate, current plans, records, and status.
• Ability to engage function leads and task owners credibly on scope, tasks, dependencies, risks, and outcomes based on experience and understanding of their work.
• Clear written and verbal communication for working-team, executive, and Board audiences, and ability to influence without authority as a service-oriented partner.
• Ability to resolve issues at the working level and escalate early with facts and options.
• Self-directed effectiveness across time zones and willingness and ability to travel as necessary, including internationally.
• Comfort working in a fast-paced, agile, hands-on environment with direct, multitasked execution and ownership.

Nice To Haves

• Advanced degree such as an MBA, MS, PharmD, or PhD.
• Rare-disease experience.
• Concurrent, multi-indication, first-in-company, or biologic launch experience.
• Experience managing or mentoring program managers.
• PMP or related certification.

Responsibilities

• Own a single authoritative integrated launch plan by indication and market, covering scope, tasks, owners, timelines, critical path, cross-functional dependencies, and shared versus indication-specific workstreams.
• Consolidate inputs from Commercial, Market Access, Medical Affairs, Regulatory, Clinical, Manufacturing, Quality, Supply Chain, Finance, and Legal; reconcile conflicts in timing, assumptions, and ownership.
• Manage plan changes through PMO governance, re-baseline when scope, indication sequencing, or timing changes, and communicate impacts to the team.
• Facilitate launch-team and working-team meetings on behalf of the Head of Operations and/or Product Launch Lead; prepare agendas and pre-reads and document decisions, actions, and owners.
• Coordinate daily with the launch working team to communicate, coordinate, influence, solve problems, and drive issue resolution; escalate critical-path issues, dependencies, and risks promptly with options.
• Coordinate Launch Readiness Reviews 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 subteams to drive alignment.
• Support the Head of Operations, Executive Leadership, and enterprise functions, including IS&T.
• Maintain launch-plan records, including RACI, decision log, risk and issue register, and change log, so the current state of each launch is 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, Head of Operations, enterprise PMO, and executive and Board forums.
• 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 integrate Expanded Access Program and ex-U.S. Named Patient Program activities, coordinate internally and externally toward NPP sales, and support transition of clinical trial, open-label extension, EAP, and NPP patients to commercial supply in each market.
• 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.

Benefits

• Annual performance bonus, subject to the applicable plan and company and individual performance.
• Health insurance (medical, dental, and vision).
• Disability, life, and long-term care insurance.
• Holiday pay.
• Tracking Free Vacation Program.
• 401(k) Plan Match.
• Educational Assistance Benefit.
• Fitness Center Reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Director