Senior/Executive Medical Director, Clinical Development (New Indications)

Responsibilities

• Clinical Development Strategy & Leadership
• Lead the design, planning, and execution of Phase 1 and Phase 2 clinical studies for A-005 and additional pipeline molecules in new therapeutic indications
• Develop and refine clinical development plans, including study synopses, protocols, and integrated development strategies for new indications
• Provide clinical and scientific leadership to cross-functional study teams, ensuring alignment on program goals, timelines, and deliverables
• Collaborate with Translational Medicine and Research teams to evaluate and prioritize new indication opportunities based on scientific rationale, competitive landscape, and unmet medical need
• Study Execution & Oversight
• Serve as the Medical Monitor for assigned Phase 1 and 2 studies, ensuring patient safety and scientific integrity
• Oversee medical aspects of study conduct, including safety surveillance, protocol amendments, and data review
• Partner with Clinical Operations, Biostatistics, and Regulatory Affairs to ensure efficient study execution and high-quality data generation
• Lead interactions with Data Safety Monitoring Boards (DSMBs) and provide medical input for safety analyses
• Regulatory & External Engagement
• Contribute to regulatory strategy and serve as a clinical representative in interactions with FDA and international regulatory authorities (EMA, PMDA, etc.)
• Prepare and review clinical sections of regulatory submissions, including IND amendments, briefing documents, and meeting packages
• Represent Alumis at scientific conferences, advisory boards, and with Key Opinion Leaders (KOLs) to advance clinical programs and gather external insights
• Build and maintain relationships with investigators, academic collaborators, and the broader medical community
• Cross-Functional Collaboration
• Work closely with Translational Sciences, Biomarker, and Pharmacology teams to integrate biomarker strategies into clinical study designs
• Collaborate with Commercial and Medical Affairs teams on disease landscape assessments and indication prioritization
• Provide clinical expertise to support business development activities, including evaluation of potential partnerships or in-licensing opportunities
• Team Development
• Mentor and develop junior medical staff, fostering a culture of scientific excellence and collaboration
• Contribute to building Alumis's clinical development capabilities as the organization grows
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• Required Qualifications
• MD required; board certification or fellowship training in Rheumatology, Dermatology, or a related specialty strongly preferred
• 10+ years of pharmaceutical/biotechnology industry experience in clinical development, with a significant focus on immunology or autoimmune diseases
• Demonstrated experience leading Phase 1 and Phase 2 clinical studies from design through data readout
• Track record of successful regulatory interactions (FDA, EMA) and experience preparing IND/CTA submissions
• Deep understanding of early clinical development, including dose-finding strategies, biomarker integration, and adaptive trial designs
• Strong scientific acumen with the ability to critically evaluate preclinical and clinical data to inform development strategy
• Experience with JAK/TYK2 inhibitors or related immunomodulatory mechanisms preferred
• Excellent leadership, communication, and interpersonal skills with the ability to influence cross-functional teams in a matrixed environment
• Strategic mindset with demonstrated ability to balance scientific rigor with business objectives
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Requirements

• Experience with indication expansion or lifecycle management for immunology assets
• Prior experience at a small or mid-sized bio

Additional Information

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Position Summary Alumis is seeking an experienced Executive Medical Director or Senior Medical Director to lead clinical development strategy and execution for Phase 1 and Phase 2 studies evaluating envudeucitinib and A-005 across new indications identified for expansion of the Alumis pipeline. This high-impact role will be instrumental in shaping the company's clinical development portfolio, from indication selection through proof-of-concept studies, and will serve as a key scientific leader interfacing with internal teams, regulatory authorities, and the external medical community. ---

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