Senior Director, Late-Stage Readiness Lead

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

If this sounds like you, keep reading!

Role Summary

We are seeking a Late-Stage Readiness Leader who will play a pivotal role in preparing Apogee’s Development functions for Phase 3 clinical studies, Biologics License Applications (BLAs), and supporting activities leading to regulatory approvals. Reporting to the SVP of Program and Portfolio Management, you will coordinate cross-functionally to prepare readiness plans and drive execution in collaboration with major stakeholders. This role requires a leader with extensive experience in late-stage clinical development, NDA or BLA submissions, and inspection-readiness planning.

Key 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.

Ideal Candidate:

• 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.
• Experience in process optimization and standardization is highly desirable.
• 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.

The anticipated salary range for candidates for this role will be $250,000 - $275,000 year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

What We Offer

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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