Clinical Scientist (Executive Dir., Senior Dir., or Director)

AiLux S.r.l.; United States; Remote; USD 180,000 - 270,000; Full time

Job summary

Ailux is seeking a Clinical Scientist at ED/Sr Dir/Director level to bridge laboratory discoveries with clinical applications in autoimmune and inflammatory diseases. You will lead trials from Phase 0 to PoC, integrate translational and biomarker strategies, and partner with Regulatory, Clinical Operations, and external partners to ensure milestones are met.

You will supervise cross-functional teams, mentor colleagues, and contribute to governance discussions while advancing Ailux's pipeline

Qualifications

• Advanced degree in immunology, autoimmunity, inflammation, or allergy.
• 3–5+ years of clinical R&D in pharma/biotech/CROs with trials experience.
• Data review and safety signal detection in trials.
• Broad understanding of FDA/EMA/ICH-GCP regulatory standards.
• Strong cross-functional leadership, data synthesis, and communication.
• Experience in experimental medicine or PoC-to-late-stage development.
• Multi-region trial experience (US, China, Europe).
• Experience with biologics, multispecifics, or cell therapies.

Responsibilities

• Clinical Strategy: design and oversight of trials (Phase 0–Phase 2a PoC), ensure PoM/PoC alignment.
• Translational Science: translate preclinical PK/PD data into starting doses and patient selection.
• Regulatory filings: prepare clinical sections for IND/CTA submissions and safety updates.
• Stakeholder management: coordinate sites, CROs, and external partners; present data at governance meetings.
• Team leadership: matrix leadership, mentorship, and capability building.

Skills

Immunology

Clinical trials

Leadership

Regulatory

Mentorship

Strategic planning

Education

PhD/MD/MS/PharmD

Job description

Ailux is an innovative biotechnology company harnessing AI to accelerate breakthrough biologic therapies in difficult immune-mediated diseases and improve the lives of patients with significant unmet medical need. Built on intelligent design and guided by people who care about transforming healthcare, our technology is redefining what is possible in biologics development, from how we select targets to how we engineer the molecules.Ailux’s vision is to light the path to new cures and fundamentally change our approach to science and drug development to redefine current treatment paradigms. We look to continue unlocking the potential of disease biology, integrate AI-enabled biologics development, and deliver effective clinical execution.Backed by an experienced leadership team, leading scientific advisors, a highly multidisciplinary organization, and strategic partnerships in biopharma, Ailux is approaching a key inflection point as its first wave of therapeutic programs advance toward clinical development. This is an opportunity to play a vital role in leading programs from pre-clinical development into the clinic and through clinical proof-of-concept, shaping the pipeline and development culture of a rapidly growing biotechnology company.

Role Overview

The Clinical Scientist (Executive Director, Senior Director or Director) bridges laboratory discoveries and clinical applications by providing active scientific and strategic contributions to therapies for autoimmune diseases, allergies, inflammatory conditions, and related immune-mediated disorders. Partnering closely with Study-Responsible Physicians/Clinical Leads, this individual contributes to the design, planning, management, execution, and monitoring of Phase 0, Phase 1, Phase 1b proof-of-mechanism (PoM), and Phase 2a proof-of-concept (PoC) studies, with scope to support later-stage development. The role integrates clinical, translational, biomarker, mechanism-of-action, disease-biology, and pathway strategies while ensuring compliance with departmental, company, ethical, quality, and regulatory standards.

The role provides scientific leadership and hands-on support across the program and study lifecycle—from clinical development planning, protocol and study-material development, and trial initiation through medical data monitoring, analysis, interpretation, reporting, dissemination, and closeout. In close partnership with Clinical Leads, the Clinical Scientist coordinates matrixed cross-functional contributors, supports clinical study reports and regulatory filings, evaluates scientific opportunities, and helps deliver governance-approved milestones within timeline and budget commitments.

As a core member of the clinical team, the Clinical Scientist helps connect Discovery Research, Translational Science, Biomarkers, and later-stage Clinical Development while partnering closely with Clinical Leads, Clinical Operations, Clinical Pharmacology, Regulatory, CMC, Safety, DMPK, Data Management, Biostatistics, Project Management, and external partners. The role drives process improvements that enhance trial efficiency and operational excellence, may manage direct reports, and mentors colleagues to foster continuous learning. Reporting to the VP of Clinical Development, this individual supports program representation at governance meetings, regulatory interactions, and external forums.

Key Accountabilities & Responsibilities

1. Clinical Strategy & Trial Execution

• Protocol & Document Ownership: Author, review, and refine clinical trial protocols, Investigator’s Brochures (IBs), ICFs, eCRFs, CSRs, and medical data-review plans.
• End-to-End Delivery: Oversee the scientific delivery of trials (Phase 0 through Phase 2a PoC), ensuring study design integrity, alignment with PoM/PoC hypotheses, and ICH-GCP compliance.
• Medical Data Monitoring: Review clinical data listings, eCRFs, lab results, AEs/SAEs, and concomitant medications for medical logic, consistency, and safety signals.

2. Translational Science & Candidate-to-Clinic Transition

• Nonclinical Alignment: Partner with Research, DMPK, Toxicology, CMC, Biomarkers, and Regulatory to translate pre-clinical PK/PD and exposure-response data into starting doses, escalation schemes, and patient-selection strategies.
• Regulatory Filings: Prepare clinical sections for IND/CTA submissions, safety updates, BLA content, and health authority interactions.
• Innovative Trial Approaches: Incorporate adaptive designs, digital health tools, novel biomarkers, and patient-centric methods where appropriate.

3. Stakeholder Management & External Partnerships

• Site & Vendor Governance: Serve as a primary scientific contact for trial sites, investigators, CROs, central specialty labs, and imaging vendors.
• Scientific Communication: Present strategy and data at governance meetings, advisory boards, congresses, and regulatory interactions; contribute to abstracts and manuscripts.
• KOL Collaboration: Engage external opinion leaders and academic sites to optimize trial feasibility, recruitment, and experimental medicine plans.

4. Team Leadership & Organizational Impact

• Matrix Leadership: Lead by influence within cross-functional matrix teams, establishing clear decision criteria, transparent communication, and timely issue escalation.
• Mentorship & Capability Building: Mentor junior colleagues, refine clinical development best practices, and support the expansion of Ailux's pipeline capabilities.

Experience & Skills

• Education: Advanced degree (PhD, MD, MS, PharmD, or equivalent) with strong scientific background in immunology, autoimmunity, inflammation, or allergy.
• Experience: 3–5+ years of clinical R&D experience within pharma, biotech, or CROs, with hands‑on management of clinical trials from conception through closeout.
• Data Review Expertise: Proven ability to monitor clinical trial data (eCRFs, lab values, AEs/SAEs) for scientific integrity and safety signal detection.
• Regulatory & Process Mastery: Broad understanding of global regulatory standards (FDA, EMA, ICH-GCP), trial design, and clinical documentation for IND/CTA filings.
• Execution & Soft Skills: Strong cross-functional matrix leadership, data synthesis, problem-solving, document authoring, and presentation capabilities.
• Experience in experimental medicine or taking immunology programs through PoC into later-stage development.
• Multi-region trial experience spanning the US, China, and Europe.
• Experience with biologics, multispecific antibodies, or cell therapies (T-cell engagers).
• Previous experience in a fast‑paced, growing biotechnology environment.

Leadership Profile

An analytical and collaborative scientific lead who balances detailed medical data review with overarching program strategy. Works effectively alongside Clinical Leads and cross-functional teams under uncertainty, driving rigorous, data-driven decisions to deliver differentiated immunological medicines safely and efficiently.