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 pharmacovigivalence considerations into clinical programs.
• 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

• Knowledge and experience leading or supporting interactions with global Health Authorities and contributing to regulatory strategy.
• Demonstrated ability to evaluate, interpret, and communicate complex scientific and clinical data to inform development and portfolio decisions.
• Thorough knowledge of Good Clinical Practice, statistics, and clinical trial design.
• Working understanding of synthetic biology, protein engineering, bioinformatics, or platform-driven drug development approaches.
• Proven executive-level leader with experience driving clinical development strategies and delivering high-quality outcomes across multiple stakeholders.
• Significant experience working cross-functionally within a matrixed organization and establishing productive scientific partnerships with external experts and collaborators.
• Excellent executive communication (verbal and written) and presentation skills, with the ability to influence internal and external stakeholders.
• Ability to communicate complex platform science and technical capabilities to non-scientific audiences (investors, partners, board).
• Ability to travel domestically and internationally (up to 25 to 30%).

Education & Experience

• 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.
• PREFERRED: Experience with clinical development in smaller biotech settings and managing partnerships or in-licensed programs.