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DIRECTOR, CLINICAL OUTCOMES ASSESSMENT

Aesara Inc
Durham, NC Full Time
POSTED ON 1/20/2025
AVAILABLE BEFORE 2/19/2025

About AESARA 

AESARA is a Value & Access agency, providing consulting solutions and creating a suite of software tools to help pharmaceutical companies communicate the value of their products and deliver to the market faster and more efficiently.  

We impact access and outcomes by helping clients develop intelligent and technically sound results and translate them into effective communication for experts and non-experts alike. 

We are committed to assembling diverse teams and supporting employee success and long-term growth. We donate a portion of our profits to the AESARA Foundation supporting disaster relief and resiliency efforts, making a difference as global citizens. 

The Opportunity 

  • Work with AESARA – the digital-forward market access agency – impacting healthcare decision-making to improve people’s lives. 
  • Manage project team execution balancing technical expertise, strong interpersonal, communication, and presentation skills, interests in digital applications. 
  • Bring areas of interest such as payer research, strong research methodology and expertise, Market Access strategy and communications, modeling to drive excellence. 

Responsibilities 

As Director within the Value Evidence Team’s Center of Excellence, you will provide specialized technical expertise in Clinical Outcome Assessment (COA) that helps our clients to optimize the development and execution of COA strategies. He/she will:

  • Lead/manage technical execution of AESARA’s projects‐‐ developing quality, timely and impactful deliverables. 
  • Serve as AESARA’s technical expert on the COA related topics and collaborate with external experts to advance new COA policies, standards, and methodologies.
  • Support clients’ needs in developing and executing COA strategies and tactic plans, including qualitative research and the selection, development, and validation of COA measures. 
  • Help clients prepare relevant COA sections of documents and communications for meetings with the FDA.
  • Develop and deliver training materials for education on COA measures for clients and internal AESARA stakeholders.
  • Identify opportunities, processes, and methods to improve effectiveness and/or efficiency of the Value Evidence Team.
  • Drive development of AESARA’s organization by providing input into the building and shaping of the organization. 

Qualifications 

  • PhD or clinical doctorate (MD or Pharm D) coupled with a master’s degree in a relevant field (e.g., outcomes research, psychology, psychometrics)
  • At least 5 years of relevant experience in pharmaceutical industry, consulting, or academia.
  • Deep understanding of the COA requirements for regulatory and HTA bodies
  • Hands-on experience in engaging regulatory agencies.  
  • Strong track record of publication in the COA field.
  • Strong knowledge of selection, development, and validation of COA measures
  • Ability to analyze and synthesize qualitative and quantitative data.
  • Ability to communicate effectively (oral and written) to stakeholders with limited COA knowledge.
  • Excellent interpersonal skills and being a strong collaborator, a self-starter and an independent thinker.
  • An entrepreneurial mindset that is flexible, willing to problem solve and stretch out of comfort zones
  • Prepared to work in a flexible, fast-moving, timeline-oriented environment. Ability to prioritize time and resources.
  • Agile, creative, and innovative 
  • Exemplary professional values and behaviors, aligned to the AESARA values: 
    1. Trusted: We listen, act, and deliver for our clients and each other 
    2. Bold: We infuse expertise with confidence and challenge ourselves to create a solution 
    3. Transformative: We create meaningful advancement to shape future success. 

Why AESARA?

AESARA offers a competitive compensation and benefits package including medical, dental, vision, Flexible Spending Account, 401(k) with employer match, STD, voluntary benefits, generous time off benefits, the opportunity to participate in stock option and bonus plans, career development/growth and participation in service initiatives through the AESARA Foundation.   

We are a remote organization, wherever you are most effective is exactly where AESARA needs you to be.

AESARA is a certified woman- and minority-owned business.

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