Director Clinical Development

Director – Clinical Development

Summary

Serves as a key member of the Late‑Stage Cross‑Functional Team, providing leadership for the clinical scientific aspects of global Phase 2 and/or Phase 3 programs. Acts as a bridge between strategic oversight and operational execution, ensuring that pivotal clinical trials are designed and conducted with high scientific rigor to support NDA and BLA submissions.

Essential Duties and Responsibilities

Leads the scientific design and clinical oversight of global Phase 3 trials, ensuring study design alignment with the target product profile (TPP). Serves as the primary clinical representative on the Global Study Team, collaborating with Regulatory Affairs, Biostatistics, and Clinical Operations to maintain project timelines. Leads cross‑functional development of clinical data collection, monitoring, and signal detection strategies, and actively participates in ongoing study data review. Synthesizes study-level observations into clear recommendations for senior clinical development leadership. Reviews template informed consent forms, study charters, manuals, work instructions, case report form specifications, and statements of work to ensure accuracy, protocol alignment, and consistency with the Investigator Brochure(s). Develops study training materials and delivers training to internal teams, external partners, and investigational site staff. Drafts and manages responses to health authority and ethics committee questions, site inquiries regarding protocol interpretation, and data clarifications. Participates in cross‑functional working groups to provide clinical input into the development of program‑wide processes. Contributes to and reviews Investigator Brochures, data presentations, and scientific publications. Collaborates on the development of clinical study reports and supports preparation for potential NDA and BLA submissions. Conducts and presents literature analyses to assess the evolving therapeutic landscape and inform clinical research objectives.

Additional Qualifications

Demonstrates well‑rounded experience in clinical trial design and conduct, including knowledge of GCP and ICH guidelines, a solid understanding of functional roles within drug development, and a proven ability to collaborate effectively on cross‑functional clinical study teams. Exhibits strong oral and written communication skills, with the ability to clearly convey scientific information and present technical concepts to both technical and non‑technical audiences. Demonstrates independent research capability, sound judgment, strong organizational skills, and effective problem‑solving and conflict‑resolution skills. Brings experience writing, editing, and reviewing clinical documents, including protocols, investigator brochures, informed consent templates, study manuals, vendor charters, conference presentations, and journal publications. Effectively engages with key opinion leaders, investigators, coordinators, and site staff to exchange scientific input related to protocol development and study execution. Relevant therapeutic area experience is preferred, with late‑stage clinical experience highly desirable. Demonstrates strong matrix leadership skills with the ability to influence peers across Operations, Regulatory, and Statistics functions, as well as a track record of technical proficiency, scientific creativity, collaboration, and independent thinking. Maintains current, active engagement in the field and demonstrates expert knowledge of scientific principles internally and externally, with sustained performance and accomplishment. Experience working in an FDA‑regulated environment and knowledge of GMPs as they apply to laboratory practices are highly desired.

Education or Degree Requirements

A PhD, PharmD, or equivalent scientific doctorate is preferred. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or equivalent experience may be considered.

Minimum Professional Experience

8-10 years of work experience in a research and/or development with a minimum global Phase 3 studies managed through start-up and/or database lock. Post-doctoral work may serve as experience. Experience in Immunology and Inflammation, specifically in atopic dermatitis or alopecia areata is a plus.