Unclassified - Boston, MA

posted 3 months ago

Full-time - Mid Level
Boston, MA

About the position

The Clinical Imaging Scientist/Physician will provide scientific and clinical input to all aspects of late stage product development. This includes the design, delivery, and interpretation of pivotal clinical trials and studies that further characterize the overall benefit, risk, and value of late stage development products in the respiratory and immunology therapeutic area. The Clinical Imaging Scientist/Physician must possess strong analytical skills, as they will be responsible for the quality of processes and outcomes related to imaging endpoints. An important aspect of this role is the ability to analyze large amounts of data, identify potential data quality issues, and explore opportunities for novel analyses. This position focuses on the integration of clinical imaging in late stage clinical trials and provides strategic and technical expertise on the conception and implementation of imaging endpoints to be included in later phases of clinical development (Phase II-III). Responsibilities include conducting literature research and maintaining frequent interaction with internal and external key experts. The role also supports the consistent implementation of standardized imaging protocols across development programs, including training the wider clinical team. When new requirements for imaging data collection arise, the Clinical Imaging Scientist/Physician will collaborate with the drug project team, internal/external key experts, and imaging CROs to ensure optimal image data collection and analysis. We are seeking a highly motivated, interactive, and creative individual who can work across a highly matrixed environment to advance clinical drug development programs throughout the clinical development process. The successful candidate will collaborate with colleagues within late stage development in Respiratory & Immunology and early stage development groups. They will work as a member of a diverse and motivated team of researchers spanning multiple divisions and geographies within Biopharmaceuticals R&D. Clear written and verbal communication skills, along with the capability to present scientific designs and results to multidisciplinary teams and key stakeholders, are essential. The role requires both independent and collaborative work, contributing significantly to study design, regulatory submissions, process improvements, and mentoring.

Responsibilities

  • Provide scientific leadership in the innovative design, execution, and interpretation of clinical trials.
  • Act as the lead medical imaging scientist/physician in several drug projects across the respiratory and immunology portfolio.
  • Provide technical support to develop, implement, and maintain standardized imaging protocols.
  • Offer imaging expert input to the design, implementation, and reporting of clinical studies with imaging-based endpoints, including support for protocol authoring and regulatory documents/defense.
  • Provide technical input related to imaging for study teams, including site selection, site training, monitor training, logistics, data collection, and problem-solving.
  • Contribute to imaging charter development, radiology manuals, site initiation, data collection, interpretation, and reporting, working closely with study teams and imaging CROs.
  • Act as an imaging subject matter expert to enhance understanding of imaging endpoints within clinical development, including providing imaging training and education as required.
  • Collaborate effectively with colleagues in other functions including early and late stage Clinical Development, Biometrics, Clinical Operations, Patient Safety, Regulatory Affairs, and Medical Affairs.
  • Lead and participate in activities that ensure quality, consistency, and integration of clinical study-related deliverables.
  • Present protocol, scientific results, and other key information to multidisciplinary teams and key stakeholders, including presenting at investigator meetings.

Requirements

  • MD with imaging related specialist diploma (radiologist), and/or imaging related scientific doctoral degree (PhD), or other professional training related to clinical imaging, or science related degree with practical experience related to clinical imaging modalities (CT, MRI, PET, SPECT).
  • Practical experience from working with quantitative image analysis in a clinical and/or academic research setting, with an understanding of image acquisition and reconstruction protocols.
  • Proven ability to work collaboratively in a cross-functional setting.
  • Minimum of 3 years of experience in the pharmaceutical industry.

Nice-to-haves

  • For MD, at least 3 years clinical experience from a specialist position.
  • Knowledge and experience in lung function and other physiological assessments is desired.
  • Experience of supporting clinical trials, particularly Phase II and Phase III, preferably with an imaging component.

Benefits

  • 401(k) plan
  • Paid vacation and holidays
  • Paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage
  • Short-term incentive bonus opportunity
  • Eligibility to participate in equity-based long-term incentive program
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