VP, Clinical Development

Responsibilities

• 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.

Qualifications

• M.D. or M.D./Ph.D. degree ; advanced knowledge in immunology, protein therapeutics, oncology, or related areas relevant to Absci's focus areas
• 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
• Preferred (but not required): Track record of successfully advancing clinical programs through IND or CTA various stages of clinical development filings
• Experience in therapeutic areas relevant to Absci (oncology, immunology, protein therapeutics, dermatology, women’s health, immunology)