VP, Clinical Development

Absci•Vancouver, WA

19h•$355,000 - $390,000•Remote

About The Position

Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci is a global company headquartered in Vancouver, WA, and maintains offices in New York City, Switzerland, and Serbia. Reporting to the Chief Medical Officer (CMO), the Vice President, Clinical Development provides executive leadership for the company's clinical research and development activities, including Absci's proprietary biologics programs and partner-developed therapeutics leveraging our synthetic biology and AI-driven protein engineering platform. The Vice President is responsible for the strategic planning, execution, and oversight of clinical development strategies that support Absci's transition from platform provider to integrated biotherapeutics company. The Vice President, Clinical Development serves as a senior leader within Clinical Development, accountable for clinical trial design, execution, regulatory strategy, data integrity, and cross-functional alignment across internal programs and external partnerships. The role partners closely with our Protein Engineering, Bioinformatics, Clinical Operations, Regulatory Affairs, and Drug Safety teams to ensure clinical programs leverage Absci's differentiated platform capabilities while meeting regulatory requirements and medical standards. The Vice President, Clinical Development contributes to portfolio-level decision-making and represents Clinical Development in internal governance forums, external partnerships, and investor engagements.

Requirements

Bring knowledge and experience leading or supporting interactions with global Health Authorities and contributing to regulatory strategy
Demonstrate ability to evaluate, interpret, and communicate complex scientific and clinical data to inform development and portfolio decisions
Bring 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)
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

Nice To Haves

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)

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.