Head of Product Launch Program Management (Rare Disease)
rezolutebio · Redwood City · onsite
Key Responsibilities:
- 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.
- 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.
- Works daily 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.
- 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.
- 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 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.
- 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:
- 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 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.
- 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
- 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