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

Key Responsibilities
- 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 to align 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 (safety surveillance, protocol amendments, 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 regulators (EMA, PMDA, etc.)
- Prepare and review clinical sections of regulatory submissions (IND amendments, briefing documents, meeting packages)
- Represent the company at scientific conferences, advisory boards, and with Key Opinion Leaders (KOLs)
- Build relationships with investigators, academic collaborators, and the broader medical community
- Integrate biomarker strategies into clinical study designs (Translational Sciences, Biomarker, Pharmacology)
- Collaborate with Commercial and Medical Affairs on disease landscape assessments and indication prioritization
- Provide clinical expertise to support business development (partnerships, in-licensing)
- Mentor and develop junior medical staff; contribute to building clinical development capabilities

Required Qualifications
- MD required; board certification or fellowship training in Rheumatology, Dermatology, or related specialty strongly preferred
- 10+ years of pharmaceutical/biotechnology industry experience in clinical development, focused on immunology/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 (dose-finding, biomarker integration, adaptive trial designs)
- Strong scientific acumen in evaluating preclinical/clinical data to inform strategy
- Excellent leadership, communication, and interpersonal skills in a matrixed environment
- Strategic mindset balancing scientific rigor with business objectives

Preferred Qualifications
- Experience with indication expansion or lifecycle management for immunology assets
- Prior experience at a small or mid-sized biotechnology company
- Established relationships with KOLs in rheumatology, dermatology, or gastroenterology
- Experience across multiple autoimmune indications (e.g., psoriasis, psoriatic arthritis, lupus, atopic dermatitis, CNS inflammatory/degenerative diseases)
- Familiarity with expedited regulatory pathways (Breakthrough Therapy, Fast Track)
- Experience with JAK/TYK2 inhibitors or related immunomodulatory mechanisms

Travel Requirements
- Travel required (approximately 20–30%) for investigator meetings, conferences, regulatory interactions, and site visits.