Senior Director, Clinical Research and Development, Autoimmune

Overview

We are seeking an accomplished clinical development professional to lead a pioneering autoimmune therapy program within a high-growth biotech environment. This leadership role offers the opportunity to define and execute clinical strategies for novel immune cell-based therapies targeting diseases such as lupus, IgG4-related conditions, and multiple sclerosis. The ideal candidate will bring strategic vision, hands-on execution skills, and experience in early-phase trials to drive success in a fast-paced, cross-functional team setting.

Responsibilities

Clinical Strategy & Program Leadership

• Develop and lead the overall clinical roadmap for key autoimmune therapy programs.

• Evaluate target indications based on clinical opportunity, scientific basis, and market viability.

• Contribute to corporate-level decision-making as part of the executive team.

Study Design & Execution

• Oversee design and delivery of Phase 1/2 and subsequent pivotal trials across autoimmune indications.

• Lead protocol development, safety monitoring, data interpretation, and study reporting.

• Collaborate with translational research teams to implement biomarker and immunology endpoints into clinical studies.

• Engage with external experts and clinical investigators to support data generation and expand the therapeutic platform.

Regulatory Strategy

• Drive global regulatory submission processes (pre-IND, IND, and beyond).

• Represent clinical programs in meetings with regulatory authorities and ensure alignment with evolving regulatory standards.

• Design trials that enable accelerated development pathways where applicable.

Team Building & Cross-Functional Collaboration

• Establish and lead a nimble clinical development team, growing the function as the pipeline advances.

• Partner with internal teams including clinical operations, regulatory affairs, translational research, manufacturing, and business development to align and execute program goals.

• Act as an internal and external ambassador for the autoimmune development strategy, presenting to senior leadership, partners, and stakeholders.

Qualifications

• MD or MD/PhD degree with a focus or experience in immunology or autoimmune diseases.

• Over 10 years of clinical development experience, with proven leadership in early-phase trials.

• Prior experience in a senior clinical development position (Executive Director or at least 3 years as Senior Director) with readiness to lead a strategic function.

• Demonstrated experience in early clinical program buildouts at companies with lean structures.

• Expertise in protocol authorship, data evaluation, and regulatory interactions.

• Experience with biologics, cell therapies, or B-cell targeting mechanisms is a significant plus.

• Deep knowledge of GCP, ICH guidelines, and FDA/EMA regulatory frameworks.

• Excellent communication in English; Mandarin proficiency is an advantage.

• Willingness to travel internationally and work on-site in Taipei multiple days per week.