Head of Product Launch Program Management (Rare Disease)

Rezolute•Redwood City, CA

22d•$240,000 - $290,000•Remote

About The Position

The Director, Product Launch Program Management is a member of Rezolute’s Program Management Office (PMO), reporting to the Senior Vice President, Operations and directly supporting the Commercial Product Launch Lead (Head of Marketing). The role owns and maintains the integrated launch plan by indication and market across the U.S. and priority ex-U.S. countries, helping the Product Launch Lead and functional leaders make decisions and execute launch strategy. It works daily with PMO colleagues and program managers supporting Development and Technical Operations to coordinate cross-functional planning, dependencies, risks, and outcomes. The position requires a working understanding of contributing functions, particularly Commercial, Regulatory, Medical Affairs, Supply, and Quality, and the ability to engage teams credibly on scope, tasks, dependencies, risks, and outcomes. As Rezolute advances concurrent launches across multiple indications and markets, the role may expand to build and manage a team of Launch Program Managers. The position can be remote within the United States, with travel as necessary to company headquarters in Redwood City, California, and to launch-team, partner, and ex-U.S. working sessions.

Requirements

Bachelor’s degree required.
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.
Working knowledge of launch scope across Commercial, Medical Affairs, Supply and Quality, and Regulatory, including the functional areas specified in the posting.
Proficiency with Smartsheet, MS Project, or equivalent tools.
Ability to maintain accurate, current plans, records, and status; engage function leads and task owners on scope, dependencies, risks, and outcomes; communicate to working teams and executive and Board audiences; influence without authority; resolve issues and escalate early with facts and options.
Self-directed effectiveness across time zones and willingness and ability to travel as necessary, including internationally.
Comfort with direct, multitasked execution in a fast-paced, agile, hands-on environment.

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.
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.
Experience managing or mentoring program managers.
PMP or related certification.
Working knowledge of rare-disease regulatory pathways such as Orphan Drug Designation, Breakthrough Therapy, Priority Review, PRIME, and conditional approval.

Responsibilities

Own a single, authoritative integrated launch plan by indication and market, covering scope, tasks, owners, timelines, critical path, and cross-functional dependencies, including shared and indication-specific workstreams.
Consolidate inputs from Commercial, Market Access, Medical Affairs, Regulatory, Clinical, Manufacturing, Quality, Supply Chain, Finance, and Legal, reconciling 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 ownership.
Coordinate and influence the launch working team, resolve issues, and 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.
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 toward NPP sales, and support transitions 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.