Sr. Program Manager
Posted 4 hours ago USD 200,000 - 225,000 / year
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI)
We are seeking a Sr. Program Manager to drive alignment and execution of our development and pre-commercial planning function. This individual will work directly with cross-functional leads and the working team to ensure that functional plans reflect accurate content, interdependencies, and risks, and that these roll up into an enterprise-level integrated plan.
Working in a matrixed environment, the Sr. Program Manager will ensure the company’s pivotal Phase 3 studies, BLA submission, and commercial launch activities are fully coordinated, transparent, and on track.
Key Responsibilities
Cross-Functional Plan Management
Education & Experience
Qualifying employees are eligible to participate in benefit programs such as:
We are seeking a Sr. Program Manager to drive alignment and execution of our development and pre-commercial planning function. This individual will work directly with cross-functional leads and the working team to ensure that functional plans reflect accurate content, interdependencies, and risks, and that these roll up into an enterprise-level integrated plan.
Working in a matrixed environment, the Sr. Program Manager will ensure the company’s pivotal Phase 3 studies, BLA submission, and commercial launch activities are fully coordinated, transparent, and on track.
Key Responsibilities
Cross-Functional Plan Management
- Partner with functional leads (including Clinical, Regulatory, CMC, Quality, Commercial, Medical Affairs) to ensure functional project plans are complete, accurate, and interconnected.
- Validate that key interdependencies, risks, and critical path items are captured and reflected in the enterprise integrated plan.
- Drive proactive discussion around trade-offs, resourcing, risk mitigation and contingency planning
- Maintain the master integrated plan covering pivotal Phase 3 execution, BLA submission, and incorporating U.S. launch readiness.
- Provide ongoing visibility into progress, risks, and scenario updates for leadership.
- Highlight bottlenecks and ensure timely escalation/resolution.
- Work with functional leaders and the Head of Operation to define KPI, Critical Path, On-Time measures, organizing this in support of the Core team.
- Facilitate cross-functional working team meetings; capture and track decisions, risks, and action items.
- Translate complex program status into clear updates for senior leadership and governance forums.
- Ensure consistency and transparency of planning data across all stakeholders
- Build and manage Smartsheet-based timelines, dashboards, and automated reports.
- Act as a subject-matter resource for Smartsheet use and integration across function
Education & Experience
- Bachelor’s degree required; advanced degree in Life Sciences, Business, or related field preferred.
- 7+ years of project/program management experience in biotech or pharma, with working knowledge of Phase 3 to pre-commercial readiness.
- Strong understanding of core functional content areas including Clinical Development, Regulatory, CMC, Commercial, and Medical Affairs.
- Experience supporting BLA/NDA submissions and/or product launches strongly preferred.
- Advanced Smartsheet expertise (required).
- Demonstrated experience in project and or program management. Project Management certifications encouraged.
- Strong ability to synthesize information across multiple functions into an integrated view.
- Proven skill in managing interdependencies and communicating trade-offs.
- Excellent written and verbal communication skills; able to engage both working teams and senior executives.
- Highly organized, detail-oriented, and able to manage competing priorities in a fast-paced environment.
- Ability to integrate in to an agile organization
Qualifying employees are eligible to participate in benefit programs such as:
- 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
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