Associate Director, Clinical Outcome Assessment

🕒 October 2

🇺🇸 United States – Remote

💵 $169.2k - $253k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Develop and execute COA strategy for one or more assigned clinical programs • Identify fit-for-purpose PRO, ClinRO, ObsRO, and PerfO instruments for label claims, regulatory submissions, and value evidence needs • Apply qualitative methods including concept elicitation, concept confirmation, and cognitive debriefing • Apply quantitative and psychometric methods to determine measurement properties, responder definitions, and meaningful change • Investigate COA endpoint availability, fitness for purpose, and regulatory precedent • Design and lead qualitative and quantitative COA evidence generation according to international scientific standards and health authority guidance • Contribute COA sections to regulatory dossiers, briefing packages, and health authority responses • Lead Patient Experience and COA evidence dossier development for external stakeholders • Coordinate COA licensing, translation, linguistic validation, and rater training • Serve as the COA point of contact on assigned clinical study teams • Represent COA in cross-functional program governance • Represent Otsuka at relevant external conferences and working groups • Build and maintain relationships with academic institutions, patient advocacy groups, clinical investigators, data vendors, and relevant vendors

🎯 Requirements

• Bachelor’s degree in outcomes research, health services research, epidemiology, psychology, public health, or a related field • 7+ years of relevant experience in COA/PRO or patient-centered outcomes research • At least 5 years specific to patient-centered/COA work • Demonstrated experience independently designing and executing COA evidence-generation projects • Working knowledge of FDA/EMA patient-focused drug development guidances and their application to clinical development • Comprehensive understanding of the pharmaceutical industry and global regulatory requirements • Understanding of product development processes across all life-cycle stages • Strong knowledge of the legal and regulatory environment influencing clinical development plans, labeling, and promotional claims • Experience partnering and collaborating with external vendors and academic/clinical investigators • Excellent written and verbal communication skills • Ability to present technical COA concepts to cross-functional and senior audiences • Master’s or Doctoral degree in a relevant field preferred • Experience supporting an NDA/BLA/MAA regulatory submission with COA content preferred • Prior conference presentation or publication in COA/PRO methodology preferred • Experience across multiple therapeutic areas preferred

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity

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