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Associate Director/Director Outcomes Medical Research, Global Medical Affairs - United States  

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Posted on : 13 May 2017

Project Description

 

This position is responsible for driving cross-functional discussions to ensure that the right clinical value elements are considered in pivotal plans for epacadostat and other pipeline agents by developing and executing the Outcomes Research strategy and ensuring coordination with Global Value, Access, & Pricing (GVAP) related activities. Working in partnership with our Development and Global Value, Access, & Pricing / HEOR unit leads, this position will also be responsible for the development of alternative evidence strategies to support the patient value proposition across the company’s portfolio of existing and emerging technologies. Global Outcomes Research will make a vital contribution to Incyte’s development and commercialization decisions and collaborate with Regional Medical Affairs and Commercial groups to execute them. Your efforts will encompass the entire life cycle of Incyte products and are critical to strategic and tactical planning.

 

The outcomes research position is expected to work in a highly collaborative and integrated fashion to efficiently coordinate prospective generation of real world data emanating from external collaborations with external experts (and their institutions & consortia) internationally and the internal communication of such data for vetting and contextual interpretation within Incyte. These data will support critical activities for the preparation for launch of in-clinic agents in the near and intermediate future.  The position reports directly to the Head, GMA. This is a Headquarters office-based position and the candidate must live or relocate to the Greater Wilmington/ Philadelphia area.

 Job Responsibilities:

  

  • Work within a multidisciplinary, matrixed organization to develop and execute successful prospective outcomes and epidemiology research strategies across Incyte’s product portfolio.
  •  Design, implement and communicate results of outcomes and epidemiology research studies that help achieve product-specific objectives.
  •  Provide expert guidance, direction and execution of design, direction and execution of evidence generation activities and projects.
  • Provide technical solutions to high-level, complex, and interdependent issues encountered in evidence generation activities; provide technical and process solutions.
  •  Provide analytical and methodological expertise on Medical Affairs and Clinical Development studies; through extensive collaboration, obtain multi-functional input on prospective and epidemiological initiatives.
  •  Represent the outcomes and epidemiology research function on cross-functional teams related to product development and commercialization.
  •  Present research results at scientific and HEOR conferences.
  •  Prepare, review, and support publication of scientific reports reflecting ongoing or completed work; work with Medical Affairs to submit manuscripts to peer-reviewed scientific journals.
  •  Collaborate closely with regional market access leads in support of global HEOR strategy and local implementation.
  •  Collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned. 
  •  Perform, as appropriate, relevant research activities which may include, but not be limited to:
  •  Design, execution, and analysis in whole or in part of longitudinal prospective observational or randomized clinical trials evaluating clinical, patient-centered, and/or economic endpoints
  •  Prospective evaluations of disease natural history and treatment patterns, including drug utilization and adherence
  •  Cross-sectional surveys of patients, caregivers, health care providers/practitioners, and/or payers/health technology assessment authorities;  
  •  Development and validation of PRO and HRQoL instruments: 

  

    • Prepare and/or review outcomes and epidemiology research protocols, statistical analysis plans (SAPs), and reports.

 

    • Provide leadership on epidemiology and patient-reported outcome (PRO) studies.

 

    • Communicate findings from outcomes and epidemiology studies to relevant internal and external audiences, which may include regulators, health care providers/practitioners, HTA authorities/payers, patients and others.

 

    • Build relationships and collaborations with leading authorities, academic institutions, and government entities focused in PRO and QOL work.

  

  • Understand and evaluate the needs of multiple stakeholders related to enhancing the value of PROs and QOL in healthcare decision making.
  • Establish company leadership by collaborating to enhance the importance and impact of the patient voice in public policy, regulatory approvals and other healthcare decision making. 
  • Provide internal education related to PRO and QOL initiatives and advise senior leadership.
  •  Perform all company business in accordance with regulations and company policies and procedures.

 Minimum Qualifications:

  •  Experience in outcomes research in the oncology therapeutic area, especially in melanoma, immuno-oncology and/or solid tumors, is preferred; experience in other therapeutic areas is a plus.
  •  Experience working in both global and regional roles; international experience preferred; Customer-facing experience with payers/HTAs is strongly preferred.

  •  Demonstrated experience in oncology-related registries and prospective observational studies is highly desirable. (At least 5 years of experience analyzing observational data that includes patient registry data).

  • A minimum of 10 years working in the pharmaceutical industry in the area of oncology.

  • Combination of academic training and practical experience in outcomes research and epidemiology is required.  This may be consist of:

  • Doctoral degree in a relevant discipline such as, but not limited to, health services research, health outcomes research, epidemiology, Biostatistics, or related field with a substantial statistical component.

  • Or a Master’s degree in a related discipline (as noted above), plus eight years practical experience.   

  • Experience should include the conduct of outcomes research studies, and the communication of study findings to internal and external audiences.

  • Familiarity with the role and importance of epidemiology and outcomes research in the multi-disciplinary drug development and commercialization environment.

  • Experience working with CROs, particularly real-world data providers and analytics service providers, and can evaluate vendor products and software for feasibility and applicability to in-house analytic needs.

  • Demonstrated expertise in at least one area of outcomes research (such as, but not limited to, prospective observational studies, patient-reported outcomes/health-related quality of life assessment) is highly desirable.

  • Demonstrated experience in conducting or interpreting statistical analysis is useful.

  • Experience in conducting outcomes research in different geographic regions is desirable.

  •  Proven ability to work with cross-functional teams and to interact with senior leadership. 

  •  Ability to work independently in a rapidly changing environment.

  •  Ability to travel domestic and international, when required.