Associate Director, Clinical Outcome Assessment

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Ibrido; USD 169.000 - 253.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental coverage

Vision coverage

Prescription drug plan

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Descrizione del lavoro

Otsuka Pharmaceutical Co., Ltd is seeking an Associate Director of COA to lead COA strategy for one or more clinical programs, shaping endpoint strategy and value evidence for regulatory submissions. You will collaborate across Global Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs to ensure patient-centric endpoints align with product profiles throughout the lifecycle.

You will drive COA evidence generation, contribute to dossiers, coordinate licensing and

Competenze

• Bachelor's degree in outcomes research, health services research, epidemiology, psychology, public health, or related field.
• 7+ years in COA/PRO with at least 5 years in patient-centered/COA work.
• Experience independently designing and executing COA evidence-generation projects.
• Working knowledge of FDA/EMA guidances and global regulatory context.
• Experience partnering with external vendors and clinical investigators.

Mansioni

• Identify fit-for-purpose COAs (PRO, ClinRO, ObsRO, PerfO) for assigned programs.
• Design and lead COA evidence generation for assigned programs.
• Contribute COA sections to regulatory dossiers and health authority responses.
• Coordinate COA licensing, translation, and linguistic validation.
• Serve as COA point of contact on clinical study teams and at external forums.

Conoscenze

COA strategy

Evidence generation

Regulatory awareness

Cross-functional work

Communication

Vendor collaboration

Formazione

Bachelor's degree in outcomes research / related field

Master's or Doctoral degree (preferred)

Descrizione del lavoro

**Role Summary**The Associate Director, COA develops and executes the COA strategy for one or more assigned clinical programs, applying qualitative and quantitative methods to support endpoint selection, evidence generation, and regulatory dossier input. The role operates with a high degree of independence on assigned programs, with Director-level oversight reserved for cross-program, indication-level, or enterprise-scope decisions.This role is part of a global cross-functional team and interacts with Global Clinical Development, Clinical Management, Regulatory Affairs, Biostatistics, Value Evidence, Global Medical Affairs, Pharmacovigilance, Patient Advocacy & Stakeholder Management functions to ensure clinical development programs reflect appropriate patient-centric endpoint strategy and value differentiation needs in alignment with the target product profile across the product lifecycle.**Job Responsibilities:****Endpoint & COA strategy*** Identify fit-for-purpose COAs (PRO, ClinRO, ObsRO, PerfO) for assigned programs, in the context of label claims, regulatory submissions, and value evidence needs.* Apply qualitative methods (concept elicitation, concept confirmation, cognitive debriefing) and quantitative/psychometric methods to determine measurement properties, responder definitions, and meaningful-change.* Investigate the extent to which COA endpoints are available, fit-for-purpose, and have regulatory precedent for assigned programs, in support of the product target label claim and value evidence needs.**Regulatory & evidence generation*** Design and lead generation of COA evidence (qualitative/quantitative) for assigned programs, per international scientific standards and health authority guidance.* Contribute COA sections to regulatory dossiers, briefing packages, and health authority responses for assigned programs.* Lead Patient Experience & COA evidence dossier development for external stakeholders (eg, regulatory and health authorities)* Coordinate COA licensing, translation, linguistic validation, and rater training for assigned programs, in collaboration with Global Clinical Development/Clinical Management.**Cross-functional & external*** 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 (e.g., ISPOR, ISOQOL) as assigned.* Build and maintain relationships with academic institutions, patient advocacy groups, clinical investigators, data vendors, and vendors relevant to assigned programs.**Required Qualifications:*** 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, with 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 regulatory requirements from a global perspective, and product development processes at 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.**Preferred Qualifications*** Master or Doctoral degree in a relevant field.* Experience supporting a regulatory submission (NDA/BLA/MAA) with COA content.* Prior conference presentation or publication in COA/PRO methodology.* Experience across multiple therapeutic areas.**Scope, Autonomy & External Representation*** Scope: one program, or a small cluster of related indications.* Autonomy: owns COA strategy for assigned programs; escalates cross-program or enterprise-level decisions to a Director.* External representation: attends and increasingly presents at external scientific forums; not a primary Otsuka stakeholder for external interactions.**Competencies****Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.**Empowered Development -** Play an active role in professional development as a business imperative.Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.**Application Deadline**: This will be posted for a minimum of 5 business days.**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.Come discover more about Otsuka and our benefit offerings; .**Join Our Talent Community:** Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we'll notify you about future opportunities that align with your background.**Disclaimer:**This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].**Statement Regarding Job Recruiting Fraud Scams**At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, Otsuka