Director, Immunology Clinical Research

Creative Solutions Services, LLC; Wilmington (DE); On-site; USD 150,000 - 190,000; Full time

Job summary

Kaztronix is seeking an experienced Director, Clinical Research Scientist to support clinical development across studies and programs. You will collaborate with physicians and cross-functional teams to drive study execution, clinical strategy, data review, and regulatory deliverables.

The ideal candidate has immunology-focused drug development experience, with 4–6+ years in clinical research, strong documentation skills for INDs and CSRs, and the ability to lead matrix teams in a fast-paced

Qualifications

• Bachelor's or advanced degree in a scientific or life sciences discipline.
• Pharm.D. or Ph.D. preferred.
• Approximately 4-6+ years of research experience, including at least 3+ years of clinical research and/or drug development experience.
• Immunology experience is required.
• Experience supporting clinical studies from protocol development through data review and clinical reporting.
• Demonstrated experience with clinical research documentation and regulatory submissions.
• Strong analytical and problem-solving capabilities.
• Ability to travel up to approximately 20%.

Responsibilities

• Support the development and execution of clinical study protocols.
• Contribute to clinical development strategy for assigned compounds and programs, including clinical development plans.
• Draft and review clinical and regulatory documents, including INDs, IND amendments, Clinical Study Reports (CSRs), Investigator's Brochures, annual reports, and other health authority submissions.
• Provide clinical input into eCRF design, SAPs, and Tables, Listings, and Figures (TLFs).
• Monitor, review, analyze, and summarize clinical safety and efficacy data from ongoing studies.
• Collaborate with cross-functional study teams to conduct timely and thorough clinical data reviews and identify meaningful trends.
• Lead clinical matrix teams for assigned studies and represent Clinical Development on project teams.
• Serve as a key liaison with internal project teams, CROs, investigators, and other external partners.
• Prepare and present clinical updates to senior leadership, project teams, governance groups, steering committees, and other relevant stakeholders.
• Collaborate with cross-functional colleagues on study training, clinical results, and interactions with investigators and key opinion leaders.
• Develop relationships with external consultants and subject matter experts to obtain input on clinical strategy and protocol design.
• Contribute to the preparation and review of study abstracts, posters, oral presentations, and manuscripts.
• Maintain awareness of the competitive landscape, including assets with similar mechanisms of action and evolving standards of care within relevant disease areas.

Skills

Immunology

Clinical research

Regulatory submissions

Data review

Cross-functional leadership

Communication

Education

Bachelor's or advanced degree in scientific or life sciences

Pharm.D. or Ph.D. preferred

Job description

Kaztronix is seeking an experienced Director, Clinical Research Scientist to support clinical development across studies and programs. You will collaborate with physicians and cross-functional teams to drive study execution, clinical strategy, data review, and regulatory deliverables.

The ideal candidate has immunology-focused drug development experience, with 4–6+ years in clinical research, strong documentation skills for INDs and CSRs, and the ability to lead matrix teams in a fast-paced