About the roleReporting to the Vice President, Global Program Leadership, the Director will partner with functional leaders across Clinical Development, Regulatory Affairs, CMC, Clinical Operations, Medical Affairs, Quality, Biometrics, and external vendors to ensure the successful planning and execution of Quetzal's development strategy.
This role will be responsible for maintaining integrated program plans and detailed project plans (i.e. NDA filing, commercial launch planning),driving cross-functional alignment, managing risks and dependencies, and delivering clear communications to executive leadership. The ideal candidate combines strong drug development knowledge with exceptional project leadership capabilities and thrives in a fast-paced biotechnology environment.
What you'll doProgram Management & Execution- Partner with the VP, Global Program Leadership to develop and maintain integrated development plans for Quetzal's development programs.
- Partner with the cross-functional Program Team functional leaders to define program strategy, conduct scenario planning, and translate strategy into executable plans to achieve program objectives
- Identify and manage program-level risks, assumptions, and interdependencies; support cross-functional mitigation planning, issue resolution, and formal Risk Log generation/maintenance
- Drive cross-functional execution against approved program objectives, milestones, and timelines.
- Support portfolio planning and strategic program initiatives.
- Ensure alignment across Clinical Development, Regulatory Affairs, CMC, Quality, and other key functions.
- Proactively identify and communicate risk and decision-points with mitigation opportunities and impact assessment
- Develop and manage integrated program timelines and critical path analyses.
- Identify interdependence across functional workstreams.
- Build scenario analyses and contingency plans to support decision-making.
- Track program progresses and proactively identifies risks, delays, and resource challenges.
Cross-Functional Team Management- Coordinate and facilitate cross-functional program team meetings.
- Drive accountability and follow-up on key decisions and action items.
- Promote collaboration among internal stakeholders and external partners.
- Ensure timely communication of goals, deliverables, and program updates.
- Support vendor oversight, providing PM-to-PM partnership for timely and cost effective delivery of program needs
Key functional project plans and sub-team facilitation:- Support Program Team and individual functions in critical project plan generation, ensuring alignment with overall development plan.
- Regulatory Submission Plan:
- Together with Regulatory, generate and oversee NDA submission plan and ex-US submission plans, identify critical path activities and potential risk, support scenario planning
- Ensure timely cross-functional delivery against submission plan
- Support Regulatory in vendor oversight
- Prepare dashboards and graphics for Program Team and executive communication and discussions
- Commercial Launch Plan:
- Together with key functional stakeholders, support generation and oversight of commercial launch plan
- Aligning with launch plan with submission plan and integrated program plan and ensuring timely launch-readiness and proactively identifying impact of shifts across plans
- Identify key gaps and risks to plan with proactive escalation and mitigation
Governance & Executive Reporting- Develop program dashboards, status reports, and support generation of executive presentations.
- Support governance meetings and portfolio reviews.
Financial & Resource Management- Support budgeting, forecasting, and resource planning activities.
- Monitor program expenditures and key vendor engagements.
- Collaborate with Finance and functional leaders on resource allocation and planning.
- Support evaluation of outsourcing strategies and vendor performance.
Continuous Improvement- Drive implementation of program management best practices, tools, and processes.
- Promote operational excellence across development teams.
- Contribute to building Quetzal's program management capabilities as the organization grows.
QualificationsRequired- Bachelor's degree in Life Sciences, Public Health, Pharmacy, Engineering, or related discipline.
- 8+ years of experience in biotechnology, pharmaceutical, or life sciences environments.
- 5+ years of program or project management experience supporting drug development programs.
- Demonstrated understanding of clinical development and regulatory processes.
- Strong leadership, communication, and organizational skills.
- Proven ability to influence cross-functional teams without direct authority.
- Experience supporting clinical-stage development programs.
Preferred- Oncology, hematology, or rare disease experience.
- Phase II or Phase III development experience.
- PMP certification.
- Advanced degree (MS, MPH, MBA, PharmD, or PhD).
- Startup or emerging biotechnology company experience, governance.
- Experience in startup or high-growth company environments.
Benefits & What We OfferQuetzal Therapeutics offers eligible employees a competitive benefits package designed to support their health, wellbeing, and work-life balance. Our benefits include:
- Comprehensive medical, dental, and vision coverage
- Health and flexible spending account options
- Paid time off, sick leave, and company holidays
- Additional voluntary benefit options
Benefits and eligibility may vary based on employment status, location, and applicable plan terms and company policies.
