Jobs · Analyst · California

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

BioSpace · South San Francisco, CA · Yesterday
Analyst$300k/yrFull-time

Position Summary

Alumis Inc. 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. The role focuses on A-005, a CNS-penetrant TYK2 inhibitor with potential in neuroinflammatory and neurodegenerative diseases.

Key Responsibilities

  • 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.

  • 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.

  • 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.

  • 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.

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 conditions such as psoriasis, psoriatic arthritis, lupus, or atopic dermatitis.

  • Familiarity with regulatory pathways for expedited development (Breakthrough Therapy, Fast Track).

What We Offer

  • Opportunity to shape the clinical development strategy for a best-in-class TYK2 inhibitor portfolio.

  • High-visibility leadership role with direct interaction with executive leadership and the CMO.

  • Collaborative, science-driven culture focused on transforming patient outcomes.

  • Competitive compensation package including base salary, annual bonus, and equity participation.

  • Comprehensive benefits including health, dental, vision, 401(k), and generous PTO.

  • Free access to Genentech Bus & Ferry Share program.

  • $100 monthly cell phone stipend.

  • Unlimited PTO for Exempt employees.

  • Free onsite gym and a kitchen stocked with yummy snacks and drinks!

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