Senior Director, Late-Stage Readiness Lead

Summary

Join Apogee Therapeutics as a Late-Stage Readiness Leader and play a pivotal role in preparing the company's Development functions for Phase 3 clinical studies, Biologics License Applications (BLAs), and related regulatory approvals. Reporting to the SVP of Program and Portfolio Management, you will coordinate cross-functionally to develop and execute readiness plans. This leadership role demands extensive experience in late-stage clinical development, NDA or BLA submissions, and inspection-readiness planning. You will conduct gap analyses, drive cross-functional planning, report on progress to executive leadership, facilitate communication, and coordinate resources. The ideal candidate possesses a strong scientific background, extensive experience in late-stage drug development, and proven leadership skills. Apogee offers a competitive compensation and benefits package, including a great culture, flexible PTO, and professional development opportunities.

Requirements

• Bachelor's degree, preferably in a scientific or technical field, advanced degree a plus
• 15+ years of experience in clinical drug development, preferably spanning multiple disciplines such as clinical development, clinical operations, program management, regulatory affairs, and quality assurance, with a strong focus on phase 3 clinical trial planning and execution, global experience a plus
• Deep understanding and experience in key processes and functions involved in late-stage drug development, including NDA/BLA submissions and approvals
• Proven track record in leading cross-functional activities for late-stage clinical trials
• Excellent leadership, communication, and interpersonal skills; ability to influence and build relationships across functions at all levels
• Highly organized with excellent project management skills; ability to prioritize and manage multiple projects simultaneously, including familiarity with project management tools and software (e.g., Smartsheet, Think-Cell, etc.)
• Ability to navigate complex, multi-disciplinary environments and drive team alignment
• Exceptional ability to engage with senior leadership on strategic issues, including presenting recommendations for decision-making
• Attention to detail with the ability to balance detailed planning and execution while keeping high-level strategy in mind
• Proactive and structured approach to problem-solving, able to think cross-functionally and in multiple timeframes, and to distill into actionable plans/solutions
• Scenario planning skills, with the ability to anticipate and prepare for various outcomes
• Thrives in a fast-paced, dynamic environment
• Hands on and self-starter, willing to do address both big picture strategy and detailed planning as an individual contributor
• Position requires travel up to 40% based on business needs including frequent trips to the Apogee office in San Francisco

Responsibilities

• Conduct gap analysis and identify potential risks to trial or submission readiness, focusing on cross-functional dependencies, system/process availability, and resource planning
• Drive cross-functional planning and preparation of Phase 3 or submission readiness by collaborating with Clinical Development, Biometrics, Clinical Operations, Regulatory, Quality Assurance, Supply Chain, Research & Translational Medicine, Commercial, and Program Management/Leadership teams
• Regularly report on Phase 3 readiness progress to executive leadership, Program Team and other key stakeholders, including key milestones, risks, and overall strategy
• Facilitate communication and support problem-solving and alignment between functions to ensure milestones and deliverables are met according to agreed timelines; track identified risks and create mitigation plans
• Coordinate with functional leaders to ensure appropriate resources, funding, and timelines for Phase 3 trial preparation and BLA submission activities are in place
• Support cross-functional planning and preparation for BLA/filing strategies
• Implement best practices for clinical trial and submission readiness, using lessons learned from prior experience and optimizing for future programs
• Continuously evaluate clinical trial systems, tools, and resources and drive operational excellence in conjunction with relevant functions

Preferred Qualifications

Experience in process optimization and standardization is highly desirable

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve