Senior PRO/COA Strategy Consultant

Job not on LinkedIn

🔥 1 hour ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

🐊 Florida, New York, +1 more states – Remote

🐊 Florida – Remote 🗽 New York – Remote 🤠 Texas – Remote

⏳ Contract/Temporary

🟠 Senior

🧐 Strategy

👻 Ghost score 10%

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TransPerfect

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💼 Consulting

⚖️ Legal

📣 Marketing

💰 $425M Debt Financing - TransPerfect on 2025-04

Consulting • Legal • Marketing

TransPerfect is a global language services and technology company that provides translation, localization, interpretation, multilingual customer support (contact center/BPO), regulatory and labeling services, and creative/global marketing solutions. It combines human linguists with technology — notably the GlobalLink translation management platform and AI/machine‑translation capabilities — to help organizations launch and manage content, software, websites, and campaigns in multiple languages and markets. TransPerfect serves enterprise clients across industries such as life sciences, finance, legal, gaming, retail, and media.

📋 Description

• Develop and maintain the PRO/COA components of asset evidence strategies in partnership with asset leads. • Conduct disease, patient-experience, competitive, regulatory, and endpoint landscape reviews. • Lead fit-for-purpose PRO/COA evidence-generation studies from concept through completion, including study design, protocol development, vendor oversight, scientific interpretation, and dissemination of findings. • Develop or refine conceptual models and identify and prioritize concepts of interest. • Assess existing PRO/COA instruments for fitness for purpose and identify evidence gaps. • Support endpoint strategy development and COA evidence-generation planning. • Provide technical review and input for protocols, endpoint sections, statistical analysis plans, and related study documents. • Prepare clear recommendations, decision-support materials, and documentation for cross-functional review. • Participate as the PRO/COA subject matter expert in relevant internal and partner-facing working sessions, coordinated with the GHEVO asset lead. • Support vendor engagement and oversight for discrete COA evidence-generation activities, as needed. • Work in a strategic and scientific capacity rather than primarily administrative or project-management focused.

🎯 Requirements

• Advanced degree in a relevant field such as outcomes research, psychometrics, epidemiology, psychology, public health, or a related discipline. • Approximately 8 or more years of relevant PRO/COA experience in pharmaceutical, biotechnology, consulting, or regulatory settings. • Vendors may propose candidates with a different experience profile if the candidate clearly demonstrates the required expertise. • Demonstrated experience developing PRO/COA strategies for clinical development programs, preferably including early development. • Strong knowledge of patient-focused drug development, instrument selection, content validity, psychometric evidence, meaningful-change interpretation, and endpoint positioning. • Experience reviewing clinical protocols, statistical analysis plans, and regulatory or evidence-planning documents. • Ability to synthesize complex evidence and communicate clear recommendations to cross-functional stakeholders. • Demonstrated ability to work independently, manage competing priorities, and operate effectively in a matrixed and co-development environment. • Experience in immunology, dermatology, gastroenterology, or neurology is desirable but not required.