layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior/Executive Medical Director, Clinical Development (New Indications) at Alumis | LAYIQ

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

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

Employer job description

Key Responsibilities

Preferred Qualifications

What We Offer

About this listing