Head of Product Launch Program Management (Rare Disease)
Rezolute
Summary
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.
Job description
Key Responsibilities
Launch Plan Ownership
- Own a single, authoritative integrated launch 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 ownership.
- Work daily with 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 integrate Expanded Access Program (EAP) and ex-U.S. Named Patient Program (NPP) activities, enabling 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.
Requirements
- Bachelor's degree required
- Advanced degree (MBA, MS, PharmD, or PhD) preferred
- 7+ years in a similar role with broad program management responsibility for a biotech therapeutic
- Rare disease experience 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
- Experience managing or mentoring program managers preferred
- Proficiency with Smartsheet, MS Project, or equivalent tools
- PMP or related certification a plus
- Working knowledge of launch scope of work for Commercial, Medical Affairs, Supply and Quality, and Regulatory
Benefits
- Health Insurance (Medical, Dental, Vision)
- Disability, Life & Long-Term Care Insurance
- Holiday Pay
- Tracking Free Vacation Program
- 401(k) Plan Match
- Educational Assistance Benefit
- Fitness Center Reimbursement
Company overview
Rezolute is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for metabolic diseases, with a primary focus on diabetes and related disorders. The company leverages its proprietary technology platform to create novel drug candidates that address unmet medical needs in metabolic health. Rezolute's pipeline includes promising therapeutic candidates targeting various aspects of metabolic regulation, including glucose control and insulin sensitivity. Their research approach combines deep understanding of metabolic pathways with innovative drug design to develop treatments that could potentially transform patient care in diabetes management. The company operates at the intersection of biotechnology and metabolic medicine, advancing candidates through clinical development stages with the goal of bringing effective new treatments to market for patients suffering from metabolic disorders worldwide.