VP, Clinical Development

🕒 Julho 28

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Absci

51 - 200 funcionários

Fundada em 2011

🧬 Biotecnologia

🤖 Inteligência Artificial

💊 Farmacêutico

Biotechnology • Artificial Intelligence • Pharmaceuticals

A Absci é uma empresa de biotecnologia que utiliza inteligência artificial generativa junto com validação em laboratório úmido para projetar de novo biológicos, principalmente anticorpos. Sua plataforma integrada de criação de medicamentos por IA realiza geração de dados, treinamento de modelos, design de novo, otimização multiparamétrica de leads e descoberta de alvos habilitada por IA (usando imunologia reversa) para descobrir novos pares de anticorpo/alvo e acelerar estudos que viabilizam IND. A Absci avança programas terapêuticos internos e em parceria—como o ABS-201, um anticorpo projetado para atacar receptores de prolactina para alopecia androgenética—e enfatiza ciclos iterativos rápidos entre IA e trabalho de laboratório para encurtar os prazos de descoberta de biológicos.

Descrição

• Provide executive both senior-level oversight and hands-on leadership for the design, planning, and execution of clinical development programs for Absci’s proprietary therapeutic candidates and select partner-developed programs utilizing our platform. • Lead the development and implementation of clinical development plans aligned with Absci's product strategy, registration pathways, and platform-enabled lifecycle management objectives. • Ensure high-quality execution of clinical trials, including protocol development, data collection, analysis, and reporting in compliance with GCP, regulatory, and medical standards. • Oversee preparation and review of key clinical documents, including protocols, Investigator's Brochures, clinical study reports, and regulatory submission materials. • Translate Absci's platform-derived insights (protein engineering, sequence, design data) into clinical development strategy and biomarker/pharmacology rationale. • Serve as a senior Clinical Development representative on cross-functional project teams, governance committees, and internal review bodies. • Partner with Clinical Operations and external CROs to ensure efficient trial execution, appropriate medical monitoring, and adherence to safety and quality standards. • Together with Clinical Operations, build and maintain relationships with key stakeholders including investigators, site staff and key thought leaders. Absci expects Clinical Development and Clinical Operations teams to visit our sites and maintain strong relationships with these important partners • Collaborate with Drug Safety to ensure ongoing evaluation of safety data and integration of pharmacovigilance considerations into clinical programs. • Work closely with Protein Engineering and Bioinformatics internal and external cross-functional teams to ensure clinical development strategy leverages platform-generated molecular and functional insights. • Contribute to enterprise decision-making through participation in portfolio reviews, partnership evaluations, investment discussions, and development governance forums. • Responsible for effectively communicating program goals, strategies, plans, issues and risks with team members, department heads, review boards, and the executive leadership team. • Support interactions with global Health Authorities by contributing to briefing packages, responses, and strategic positioning for assigned programs. • Lead clinical development due diligence and strategy for potential in-licensing, partnering, or acquisition opportunities that would utilize Absci's platform. • Engage with external experts, investigators, key opinion leaders, and advisory boards to inform clinical strategy and execution. • Represent Absci's clinical development capabilities to existing and potential pharmaceutical and biotech partners evaluating platform collaborations. • Play a leadership role in steering committee and independent data monitoring committee presentations and interactions. • Translate emerging clinical and platform-generated data into actionable insights to inform development decisions and portfolio strategy. • Support the CMO in shaping long-term clinical development capabilities, processes, and talent as Absci expands its proprietary pipeline. • Contribute to external visibility and thought leadership through presentations and publications demonstrating the clinical application of Absci's synthetic biology Platform.

🎯 Requisitos

• M.D. or M.D./Ph.D. degree • 8+ years of experience in clinical research including the design and execution of clinical trials (Phases 1-4) within a pharmaceutical or biotech environment; 5+ years leadership experience • Minimum of 8 years of experience in clinical research or drug development (Phase 1 through 3) in an academic, biotech, or industry environment; ≥6 years in a biotech/pharmaceutical setting • Preferred experience with biologics (monoclonal antibodies, protein therapeutics, cell therapy) and/or platform-based drug development models • Experience with clinical development in smaller biotech settings and managing partnerships or in-licensed programs

🏖️ Benefícios

• medical, dental, vision insurance • unlimited vacation • parental leave • employee assistance program • voluntary life and disability insurance • annual bonus potential • 401(k) with a generous company match

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