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Director, Clinical Medical Writing

Job in Northern, Floyd County, Kentucky, USA
Listing for: Zura Bio Ltd.
Full Time position
Listed on 2026-10-12
Job specializations:
  • Doctor/Physician
Salary/Wage Range or Industry Benchmark: 208000 - 238000 USD Yearly USD 208000.00 238000.00 YEAR
Job Description & How to Apply Below

Zura is a clinical‑stage biotechnology company advancing clinical development of novel therapeutic candidates for autoimmune and inflammatory diseases with significant unmet medical need. Our work is focused on understanding immune‑mediated disease and translating that science into carefully designed clinical programs, with patients and their challenges guiding our approach.

Zura is building and advancing a growing portfolio of clinical programs informed by strong scientific expertise and disciplined execution. Across the organization, teams work closely together to progress development thoughtfully, with a shared emphasis on data quality, rigor, and integrity.

At Zura, we operate as One Zura. This means collaborating across functions, valuing diverse perspectives, and taking shared ownership of our work—from problem‑solving to execution. Joining Zura means contributing to patient‑focused clinical development in a hands‑on environment where individual effort matters, collaboration is expected, and people are encouraged to grow while working toward a common goal.

What You’ll Do:

We are seeking a highly motivated and experienced Director of Clinical Medical Writing to join our dynamic team at Zura, a growing biotechnology company.

In this role, you will lead the planning, authoring, and delivery of high‑quality clinical documents across Zura's portfolio. You will be responsible for clinical medical writing strategy and timely deliverables for one or more studies, projects, or programs, including oversight when contractors or vendors are used for initial writing. This role focuses on study‑level and clinical development documents, including protocols, protocol amendments, clinical study reports, investigator's brochures, informed consent‑related content, clinical narratives, clinical sections of submission‑supporting documents, and other documents that support clinical trial execution, data interpretation, public disclosure, health authority interactions, and regulatory submissions.

You will collaborate with cross‑functional subject matter experts in Clinical Development, Clinical Operations, Biostatistics, Data Management, Drug Safety, Regulatory Affairs, Clinical Pharmacology, Bioanalytical, Nonclinical, and CMC to meet aggressive timelines. You will manage high‑quality clinical documents from start to finish, develop strong relationships, and advocate for best practices in Clinical Medical Writing, including document standards, templates, review processes, and scalable ways of working.

You will help grow the clinical medical writing function as Zura's pipeline expands.

Responsibilities:
  • Collaborate with internal teams to lead, write, and manage complex clinical documents, including clinical protocols, protocol amendments, clinical study reports, investigator's brochures, clinical narratives, informed consent‑related content, and other study‑level documents.
  • Prioritize and track timelines and deliverables for multiple clinical studies and programs in collaboration with Project Management and Clinical Operations.
  • Serve as the Clinical Medical Writing lead on assigned study teams, clinical sub‑teams, and cross‑functional project teams.
  • Develop and own study‑level document plans, ensuring on‑time, high‑quality, inspection‑ready clinical writing deliverables.
  • Develop integrated clinical document plans across studies and programs, including expected dependencies, source documents, review cycles, decision points, and escalation pathways.
  • Collaborate with Biostatistics, Data Management, Clinical Development, and Safety on statistical analysis plans, tables, figures, listings, data outputs, and data interpretation to support efficient development of CSRs, investigator's brochures, narratives, and other…
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