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Director, Clinical Research Scientist IAI

Kaztronix -
Wilmington, DE

Quick Apply

Job Details

Contract

Qualifications

Immunology
Compliance documentation
Data-driven problem-solving
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Cross-functional collaboration
Clinical trial support in drug product development
Pharmaceutical research experience
Cross-functional communication

Full Job Description

Director, Clinical Research Scientist

Position Overview

We are seeking an experienced Clinical Research Scientist to support clinical development activities across assigned studies and programs within an innovative biopharmaceutical organization. This individual will work closely with physicians and cross-functional clinical development teams to support study execution, clinical strategy, data review, and the development of key clinical and regulatory documents.

The ideal candidate will bring a strong background in clinical research and drug development, with demonstrated experience in Immunology and the ability to operate effectively in a fast-paced, highly collaborative environment.

Key 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, Statistical Analysis Plans (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.

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 understanding of clinical data review and the ability to translate clinical findings into clear scientific conclusions.
Excellent written and verbal communication skills.
Strong analytical and problem-solving capabilities.
Ability to manage multiple priorities and work effectively in a fast-paced, collaborative environment.
Comfortable working cross-functionally with Clinical, Data Management, Biostatistics, Regulatory, CROs, investigators, and other stakeholders.
Ability to travel up to approximately 20%, as business needs require.

Ideal Background

Candidates with experience in clinical development within Immunology, particularly those who have supported clinical programs and have hands-on experience with protocols, clinical data review, regulatory documentation, and cross-functional study leadership, are strongly encouraged to apply.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

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