Remote Senior Director, CT Document Authoring & Insights

WCG Clinical, Inc.; Juneau (AK); A distancia; USD 120.000 - 186.000; Jornada completa

Descripción de la vacante

WCG Clinical, Inc. is seeking a Senior Director, Clinical Trial (CT) Document Authoring & Insights to lead a team at the forefront of defining, developing, and commercializing next‑generation clinical trial document authoring and analytics capabilities.

You will translate deep domain knowledge into product requirements, working prototypes, and differentiated solutions for sponsors, CROs, and sites. The role combines clinical science, technology, and commercial strategy, requiring autonomous

Formación

• 8+ years of experience in healthcare, life sciences, clinical research, or a similarly complex, regulated industry.
• At least 3 years in a leadership, product, or engagement‑leadership capacity.
• Direct experience with clinical trial protocols and study documentation is strongly preferred
• Demonstrated track record of building something new in an environment with limited precedent
• Proven ability to lead cross‑functional initiatives across subject matter experts, product management, commercial, and engineering without direct authority
• Strong structured problem‑solving and hypothesis‑driven analytical skills
• Exceptional written and verbal communication skills
• Hands‑on orientation with a demonstrated willingness to build the first version personally
• Working knowledge of applied artificial intelligence and large language models in a regulated context is preferred
• Familiarity with FDA regulations, ICH‑GCP, and industry data standards as they relate to clinical research

Responsabilidades

• Serves as the organization's authority on clinical trial protocols and associated study documents, including protocol design conventions, informed consent materials, study plans, and regulatory submission documents, and translates that expertise into clear, buildable product requirements.
• Defines the problem set: maps current-state authoring and reviews workflows across sponsors, CROs, and sites; quantifies inefficiency, variability, and risk; and prioritizes the opportunities with the greatest client and commercial impact.
• Establishes the quality standards, evaluation criteria, and benchmarks by which new authoring and insights capabilities are assessed, including accuracy, regulatory defensibility, and reviewer acceptance.
• Develops the intellectual foundation of the offering, including frameworks, document taxonomies, reference libraries, and reusable content assets that differentiate WCG in the market.
• Translates client needs and insights into actionable recommendations that inform strategic priorities and the product roadmap.
• Leads teams of subject matter experts to execute on clinical trial document authoring and protocol optimization consulting outputs.
• Partners with Product Management and Engineering as the primary domain counterpart throughout the development lifecycle, from concept and requirements definition through design review, testing, validation, and release.
• Structures and drives workstreams to completion independently, setting the workplan, sequencing the analysis, identifying the critical path, and resolving obstacles without waiting for direction.
• Builds prototypes, models, and proof‑of-concept deliverables directly, in order to test feasibility and demonstrate value quickly rather than relying exclusively on downstream resources.
• Represents WCG at industry conferences, webinars, and podcasts, and through published thought leadership, as appropriate.

Conocimientos

Leadership

Cross-functional collaboration

Clinical research

Regulatory knowledge

Project management

Problem solving

Educación

Bachelor's degree

Advanced degree preferred

Descripción del empleo

WCG Clinical, Inc. is seeking a Senior Director, Clinical Trial (CT) Document Authoring & Insights to lead a team at the forefront of defining, developing, and commercializing next‑generation clinical trial document authoring and analytics capabilities.

You will translate deep domain knowledge into product requirements, working prototypes, and differentiated solutions for sponsors, CROs, and sites. The role combines clinical science, technology, and commercial strategy, requiring autonomous