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

About this role

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 is advancing a proprietary portfolio of TYK2 inhibitors designed to deliver best-in-class efficacy and safety across multiple autoimmune conditions. Our lead compound, envudeucitinib (ESK-001), has demonstrated compelling clinical results in psoriasis and is advancing through pivotal studies in systemic lupus erythematosus (SLE). We are expanding our pipeline with A-005 and exploring additional indications to maximize the therapeutic potential of our portfolio.

---

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 in neurology and additional new indications. A centerpiece of this role is A-005, Alumis’s CNS-penetrant TYK2 inhibitor with potential in neuroinflammatory and neurodegenerative diseases — a first-mover opportunity to bring a differentiated mechanism to patients with devastating neurological conditions. This high-impact role will shape Alumis’s expanding clinical portfolio from the ground up, from indication selection and study design through proof-of-concept readout, and will serve as a key scientific leader and external face of the program with investigators, regulatory authorities, and the broader medical community.

---

Key Responsibilities

Clinical Development Strategy & Leadership

· Lead the design, planning, and execution of Phase 1 and Phase 2 clinical studies for A-005 in neurology (e.g., neurodegenerative diseases, movement disorders) and for additional pipeline molecules in inflammatory and immunologic 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

---

Required Qualifications

· MD required; neurology experience required; board certification or fellowship training in Neurology highly desired; additional experience in inflammatory disease areas (e.g., rheumatology, dermatology) a plus

· 10+ years of pharmaceutical/biotechnology industry experience in clinical development, with a significant focus on neurology; experience in immunology or autoimmune diseases a plus

· 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

---

Preferred Qualifications

· Experience with indication expansion or lifecycle management for neurology or immunology assets

· Prior experience at a small or mid-sized biotechnology company; comfort operating in a fast-paced, resource-conscious environment

· Established relationships with KOLs in neurology; relationships in rheumatology, dermatology, or other inflammatory disease areas also valued

· Experience across multiple therapeutic indications, including neurological diseases (e.g., neurodegenerative diseases, movement disorders) and/or inflammatory condi

Similar jobs

• Director/Senior Director, Clinical Development (MD) — Axsometherapeutics · Remote
• Director/Senior Director, Clinical Development — Lexeotx · New York, New York
• Senior Director, Clinical Development — Loyal36 · Remote
• Senior Director, Clinical Development — Bridgebio · San Francisco - 1800 Owens
• Senior Director, Clinical Development — Annexonbioscience · San Francisco Bay Area
• Executive Director, Clinical Development — Centessapharmaceuticalsinc · Boston, MA
• Executive Director, Clinical Development — Mineralystherapeutics · Remote
• Director/Sr. Director Clinical Pharmacology — Bridgebio · Remote