Senior Director - Late-Stage Readiness Lead

6 days ago

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Apogee Therapeutics

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Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

• 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. • 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.

🎯 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. • 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.

🏖️ Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient 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.