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