Director, Strategy Lead, Patient Centered Outcomes (PCO)

Reports to Practice Area Lead, Patient Centered Outcomes

Job Summary

Our Director, Strategy Lead, Patient Centered Outcomes (PCO) is responsible for supervision of the pyschometrics service area unit within PCO to oversee and advise on the development and execution of clinical outcome assessment (COA) studies. Specifically, these studies will focus on supporting our clients’ COA strategy in clinical trials and non-interventional/observational studies. The PCO team supports studies of instrument development, psychometric evaluation (classical and modern methods), and analysis of COA-based study endpoints (e.g., longitudinal modelling, survival analysis, trial exploration, missing data & intercurrent event adjustment).

The majority of the work in this team is regulatory-focused. Therefore, the role involves generating evidence for submission to federal regulators at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and occasional interaction with other international regulators. Experience with regulatory agencies is essential for this role.

Essential Duties

Primary duties and responsibilities include, but are not limited to:

• Collaborating with business development, marketing, and other service areas to build greater awareness of OPEN Health Group’s (OHG) PCO team capabilities
• Leading the development of proposals and proactively engaging in seeking new opportunities 
• Managing and mentoring of mid-level and junior team members
• Overseeing the design and execution of COA studies that align with international scientific standards and regulatory authority recommendations
• Overseeing and advising on the development of study documents (such as study proposals, protocols, statistical or psychometric analysis plans, technical reports, and study presentations) and supervising psychometric and/or quantitative analyses to meet the study objectives
• Leading or advising on the COA-focused strategy for client interactions/submissions with regulatory agencies (FDA, EMA)  
• Representing OHG as a COA thought leader and subject matter expert through extramural scientific activities such as: presenting research findings to clients and other external stakeholders, development of presentations at scientific congresses, developing and delivering COA-related educational content (via webinars, scientific congress short courses, etc.), serving as a peer-reviewer, and collaboration with established scientific organizations (ISPOR, ISOQOL, C-PATH) through sub-committee or task force participation.  It is anticipated that these extramural scientific activities to will represent approximately 15% of the time spent in this role.   

Required Experience, Skills, and Qualifications

• Masters degree or PhD in Biostatistics or Psychometrics, or a relevant science (e.g., Health economics, Health Services Research, Public Health, Epidemiology, Pharmacoeconomics, or Psychology)
• 8+ years of experience in a consulting, pharmaceutical, or industry setting
• Strong experience in COA/patient-reported  outcomes research: COA instrument development/psychometric validation, quantitative analysis of COA-based clinical study endpoints, measurement strategy advising, and regulatory dossier development and submissions
• Proven track record of interacting with regulatory agencies (FDA, EMA, PMDA) and/or health authorities
• History of effective leadership of a global team, including strong skills in mentorship of early career professionals
• Strong familiarity with current analytic methods used in COA development and validation, including an understanding of appropriate methodology applications and ability to review and interpret results
• Extensive working knowledge of relevant regulatory guidance on COAs
• Strong communicator (both written and verbal) with attention to detail and accuracy
• Strong organizational and project management skills, including the ability to juggle a number of different projects and work to deadlines
• Strong experience in business development and ability to generate organic growth opportunities   
• Well-developed problem-solving skills and a genuine interest in delivering high-quality deliverables  
• Highly proficient in MS365 including Word, Excel, PowerPoint, Teams and Outlook

About OPEN Health

At OPEN Health, we connect visionary minds, pioneering science, and advanced technology to drive real impact. By uniting people, science, and technology, we activate new opportunities for biopharma innovation. Our expertise across medical affairs and market access unlocks faster, smarter routes to market. We are committed to improving patient outcomes worldwide. To learn more, visit www.openhealthgroup.com.

OPEN Health. The right combination to unlock possibilities. 

What we offer:

As a global organization, OPEN Health is committed to supporting our employees and their families through a comprehensive benefits program 

• Competitive pay, generous paid vacation, holidays and more, across all our locations
• Ongoing training and development opportunities which foster and shape your individual career path
• An active and growing commitment to bettering the communities our employees call home through our Corporate Social Responsibility program
• The opportunity to thrive in a global, collaborative environment while working every day to improve health outcomes and patient wellbeing
• Diverse, inclusive culture that encourages you to bring your whole self to work

If we sound like the sort of business environment in which you would thrive, then we would love to hear from you.

OPEN Health does not discriminate on the basis of race, sex, colour, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits. 

Master's or PhD in biostatistics, psychometrics, or related science; 8+ years in consulting/pharma/industry; strong COA research experience; regulatory agency interaction; leadership; MS365 proficiency.

Key Responsibilities

• supervising psychometrics unit
• leading COA studies
• developing regulatory submissions

Skills & Tools

Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams, Microsoft Outlook

Job Details

• Category: Project and Program Management
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — United States
• Languages: English

Benefits

• Generous paid time off

About OPEN Health

A global healthcare communications and consulting company uniting people, science, and technology to improve patient outcomes. — Industry: Consulting Services