Associate Director, Patient Centered Outcomes at GSK in Collegeville, PA
As an Associate Direction of Patient Centered Outcomes(PCO) for Specialty Care & General Medicines (SCGM) you will apply specialized technical expertise in support of GSK's drug portfolio to support Patient Reported Outcomes (PRO)/Clinical Outcome Assessment (COA) strategies. GSK's PCO-SCGM team has an integral role in in the development of integrated evidence plans to ensure that strong COA strategies support a patient-centric understanding of our specialty drugs and general medicines, with opportunities or as needed support in oncology medicines and vaccines. Our mission is to deliver 'do more, feel better' by implementing strong measurement science to capture the patient voice in demonstrating the value of our products to patients, physicians, payers and regulators. The team has educational backgrounds across a range of PRO/COA disciplines and experience in pharmaceutical, regulatory and academic settings. We work in close partnership across GSK functions including clinical development, regulatory affairs, value evidence and outcomes and patient focused drug development. We are well connected with external initiatives exploring innovative approaches to define, implement and interpret patient centric endpoints in drug development. We want to ensure that we have a focused view of our overall goals for the value of patient centric outcomes in drug development. We want to ensure that each development program has a well-characterized innovative PRO/COA strategy defined early in development with plans to develop evidence supporting those endpoints. We build rigor into implementation of PROs into our clinical trials. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Define and implement strategies for development and implementation of PRO/COA across GSKs drug portfolio, with opportunities or as needed support in oncology medicines and vaccines. Coordinate and lead the development, validation, analysis, interpretation and utilization of instruments aimed at measuring PRO/COA in the context of clinical trials and/or observational studies Ensure PROs are implemented appropriately in clinical trials, including writing relevant portions of the clinical trial protocols,training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials Collaborate with clinical and statistical teams to ensure that PRO/COA are appropriate analyzed and described in statistical analysis plans, study reports and publications Support the preparation of relevant sections of documentation and communication and questions for regulatory agency meetings, support and/or participate in meetings at regulatory agencies, and provide robust evidence in support of submission activities Prepare abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy Develop awareness of scientific, regulatory developments across GSK's drug development programs incorporating new methodology and activities to establish communication with key outcomes research opinion leaders; Keep up to date with methodologies and guidelines (including those from Regulatory Authorities) and communicate findings to VEO and functional groups as needed. Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Master's or Doctoral degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy or a closely related discipline Minimum 3 years of experience in a related role Demonstrated experience with COA development and implementation in a pharmaceutical environment. Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
Master's degree or PhD in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy or a closely related discipline Experience in pharmaceuticals, particularly in drug development, with demonstrated experience in clinical trial planning and execution Clear understanding of the FDA Patient Reported Outcomes Guidance Experience with managing PRO development and validation projects. Strong background in statistical methods for the evaluation of PROs/COA endpoints. Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data in drug development. Understanding of the evolving methods and regulatory environment with respect PRO/COA Strong communication skills, with stakeholder engagement from operations through executive levels
Salary Range:
$80K -- $100K
Minimum Qualification
Allied Health Professionals, MedicineEstimated Salary: $20 to $28 per hour based on qualifications.
Define and implement strategies for development and implementation of PRO/COA across GSKs drug portfolio, with opportunities or as needed support in oncology medicines and vaccines. Coordinate and lead the development, validation, analysis, interpretation and utilization of instruments aimed at measuring PRO/COA in the context of clinical trials and/or observational studies Ensure PROs are implemented appropriately in clinical trials, including writing relevant portions of the clinical trial protocols,training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials Collaborate with clinical and statistical teams to ensure that PRO/COA are appropriate analyzed and described in statistical analysis plans, study reports and publications Support the preparation of relevant sections of documentation and communication and questions for regulatory agency meetings, support and/or participate in meetings at regulatory agencies, and provide robust evidence in support of submission activities Prepare abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy Develop awareness of scientific, regulatory developments across GSK's drug development programs incorporating new methodology and activities to establish communication with key outcomes research opinion leaders; Keep up to date with methodologies and guidelines (including those from Regulatory Authorities) and communicate findings to VEO and functional groups as needed. Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Master's or Doctoral degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy or a closely related discipline Minimum 3 years of experience in a related role Demonstrated experience with COA development and implementation in a pharmaceutical environment. Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
Master's degree or PhD in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy or a closely related discipline Experience in pharmaceuticals, particularly in drug development, with demonstrated experience in clinical trial planning and execution Clear understanding of the FDA Patient Reported Outcomes Guidance Experience with managing PRO development and validation projects. Strong background in statistical methods for the evaluation of PROs/COA endpoints. Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data in drug development. Understanding of the evolving methods and regulatory environment with respect PRO/COA Strong communication skills, with stakeholder engagement from operations through executive levels
Salary Range:
$80K -- $100K
Minimum Qualification
Allied Health Professionals, MedicineEstimated Salary: $20 to $28 per hour based on qualifications.
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