Note: The job is a remote job and is open to candidates in USA. Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. The Vice President, Clinical Development provides executive leadership for the company's clinical research and development activities, overseeing clinical trial design, execution, and regulatory strategy to support Absci's transition from platform provider to integrated biotherapeutics company.
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
Skills
- 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
- Knowledge and experience leading or supporting interactions with global Health Authorities and contributing to regulatory strategy
- 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%)
- 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)
Benefits
- 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
Company Overview