Sr Director, CT Document Authoring Insights

The Senior Director, Clinical Trial (CT) Document Authoring & Insights leads a team at the forefront of the definition, development, and market introduction of WCG’s next generation of clinical trial document authoring and analytics capabilities. Operating at the intersection of clinical science, technology, and commercial strategy, this role translates deep domain knowledge of protocols and study documentation into product requirements, working prototypes, and differentiated solutions that measurably improve how sponsors, CROs, and sites design, author, and review trial documents, with effective departmental leadership.

This position operates with a high degree of autonomy in an ambitious, fast-moving environment: forming hypotheses, validating them rapidly with clients and internal subject matter experts, and converting them into tangible output. The position demands the judgment of a senior advisor combined with the execution orientation of a hands-on practitioner, and the ability to lead structured problem solving in one setting and produce the artifact, analysis, or client-ready deliverable in the next. Progress is achieved through successful partnering and influence, working across subject matter experts, Product Management, Business Development, and Engineering.

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The accountabilities listed below are representative of the knowledge, skills, and/or ability required.

Domain Leadership & Solution Definition

• 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.

Product Development & Cross-Functional Execution

• 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.
• Designs and executes pilots with internal experts and external clients; instruments them for measurable results; and translates findings into rapid iteration on the offering.
• Anticipates and resolves competing priorities among technical, scientific, and commercial stakeholders, escalating with a recommended course of action rather than an open question.

Innovation & Continuous Improvement

• Monitors developments in clinical trial design, regulatory expectations, industry standards (including CDISC, ICH, and TransCelerate initiatives), and applied artificial intelligence, and assesses their implications for the roadmap.
• Challenges established practice constructively, proposing better approaches supported by evidence and a clear articulation of the expected benefit.
• Continuously raises the standard of the offering, identifying opportunities to improve quality, speed, and scalability before they are surfaced by clients or competitors.
• Contributes to intellectual property development, including methodologies, prompt and template libraries, and structured content standards.

Commercial Enablement & Client Engagement

• Partners with Business Development to shape positioning, value propositions, and proof points, and participate directly in client discussions, demonstrations, and pursuit work as the credible domain voice in the room.
• Equips commercial teams with the materials, training, and technical fluency required to represent new capabilities accurately and persuasively.
• Gathers and synthesizes client feedback into a prioritized view of unmet need, and represents that perspective in roadmap and investment discussions.
• Supports the development of pricing, packaging, and delivery models in collaboration with Product Management, Finance, and Operations.

Team Leadership

• Leads and develops a team of domain and analytical professionals, establishing clear objectives, high standards, and a culture of ownership and accountability.
• Accountable for departmental performance, delivery quality, resource planning, and achievement of annual objectives.

Other

• Represents WCG at industry conferences, webinars, and podcasts, and through published thought leadership, as appropriate.
• Other duties as assigned by supervisor, which may occasionally be unrelated to the position described here.

• Bachelor’s degree or higher is required
• Advanced degree (MD, PharmD, PhD, MS, MPH, or MBA) preferred

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:

• Current PMP, CSPO, ACRP/SOCRA, or RAC certification(s) preferred, * 8+ years of experience in healthcare, life sciences, clinical research, or a similarly complex, regulated industry is required, with at least 3 years in a leadership, product, or engagement-leadership capacity
• (Preferred) Direct experience with clinical trial protocols and study documentation, including protocol authoring, amendment, review, or regulatory submission workflows, is strongly preferred
• Demonstrated record of building something new, whether a product, service line, methodology, or function, in an environment with limited precedent and incomplete information
• Experience operating effectively in a fast-paced, ambiguous environment with shifting priorities and compressed timelines
• Proven ability to lead cross-functional initiatives across subject matter experts, product management, commercial, and engineering teams without direct authority
• Strong structured problem-solving and hypothesis-driven analytical skills, comparable to those developed in a top-tier management consulting or strategy environment
• Exceptional written and verbal communication skills, including the ability to produce executive-quality deliverables and present credibly to senior client stakeholders
• Hands-on orientation with a demonstrated willingness to build the first version personally rather than delegate it
• 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
• Sound judgment in setting priorities, managing multiple concurrent workstreams, and allocating personal and team capacity
• Must be able to maintain confidentiality
• Advanced proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and collaboration and project management tools

At WCG, we invest in our people because you are the driving force behind our mission. When you grow, our impact grows. When you thrive, research accelerates. We empower you to build a meaningful career while advancing the work that improves lives.

What we offer:

Comprehensive health and financial protection - Medical, dental, vision, life and disability insurance, 401(k) with company match, and flexible spending accounts

Resources that support your whole life - Employee assistance programs and work/life balance tools

Investment in your growth - Referral bonuses, tuition reimbursement, on-the-job training, certification assistance, and continuing education support

Time to recharge - Paid holidays, vacation, and sick time

Pathways forward - Career development opportunities across One WCG

We practice transparency in everything we do, including compensation. The salary range for this position reflects our commitment to fair, competitive pay based on your qualifications, experience, skills, education, and location. Together, we’ll find the right fit for your expertise and our shared mission.

WCG delivers transformational solutions that accelerate clinical research and advance human health. We serve the experts, innovators, and pathfinders on the frontlines of science and medicine-empowering them to develop breakthrough therapies while ensuring the risks of progress never outweigh the value of human life. Together, we stimulate growth, maximize efficiency, and shape the future of clinical trials.