Senior PRO/COA Strategy Consultant

Job not on LinkedIn

🔥 3 minutes ago

🌐 United States, United Kingdom – Remote

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

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⏳ Contract/Temporary

🟠 Senior

🧐 Strategy

🦅 H1B Visa Sponsor

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👻 Ghost score 11%

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Logo of TGS

TGS

501 - 1000 employees

⚡ Energy

🤖 Artificial Intelligence

Energy • Artificial Intelligence • Digital

TGS is a leading energy data and services company formed through the merger of PGS and TGS. It specializes in providing high-quality seismic and well data to clients across the energy value chain, enabling strategic partnerships and informed decision-making. TGS also offers carbon storage and monitoring solutions, wind and solar energy operations, and advanced imaging and digital services powered by analytics and AI. With decades of geoscience expertise, TGS is committed to innovation, sustainability, and supporting energy exploration and production worldwide.

📋 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 asset lead • Support vendor engagement and oversight for discrete COA evidence-generation activities, as needed

🎯 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 • 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

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