Senior Clinical Trial Manager

🔥 23 minutes ago

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Logo of Absci

Absci

51 - 200 employees

Founded 2011

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

Biotechnology • Artificial Intelligence • Pharmaceuticals

Absci is a biotechnology company that uses generative artificial intelligence together with wet-lab validation to design de novo biologics, primarily antibodies. Its integrated AI Drug Creation Platform performs data generation, model training, de novo design, multi-parametric lead optimization, and AI-enabled target discovery (using reverse immunology) to uncover novel antibody/target pairs and accelerate IND-enabling studies. Absci advances internal and partnered therapeutic programs—such as ABS-201, a designed antibody targeting prolactin receptors for androgenetic alopecia—and emphasizes rapid iterative cycles between AI and lab work to shorten biologics discovery timelines.

📋 Description

• Independently manage all operational aspects of assigned Phase I clinical trials from startup through closeout • Oversee Contract Research Organizations (CROs) and vendors to ensure all clinical operations are carried out in alignment with the study’s goals, budget, and timelines • Develop and maintain study-level operational plans, including monitoring plans, communication plans, and risk management plans • Ensure robust patient recruitment and retention strategies are in place and effectively executed in partnership with sites and CROs • Proactively identify potential operational risks across assigned trials and develop and implement mitigation and contingency plans • Support analysis, troubleshooting, and interpretation of clinical data; prepare reports and communicate findings to internal stakeholders • Build and maintain effective working relationships with cross-functional teams, external partners, and study sites

🎯 Requirements

• Bachelor’s Degree in life sciences, pharmacology, or related field • 8 years of direct experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry • 2-3 years of experience in phase 1 clinical research and operations within the pharmaceutical or biotechnology industry • Good working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other regulatory requirements in clinical research • Familiarity with the IND and CTA filing process • Ability to travel up to 20% per month as needed to oversee clinical trials

🏖️ Benefits

• Competitive equity package applies • Wide range of medical, dental, and vision benefits • Ability to participate in employee stock purchase plan

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