• Clinical Scientist, Oncology

    Job Locations US-PA-Exton
    Posted Date 3 weeks ago(4/30/2018 11:45 AM)
    Job ID
    2018-1071
    # of Openings
    1
    Category
    Development
  • Overview

    The Clinical Scientist role is an exciting opportunity for a highly motivated individual to contribute to the development and execution of the clinical strategy and plans for Idera’s Oncology programs.

     

    Through extensive interaction with the Oncology Medical Lead and the rest of the clinical development team, this individual will have an opportunity to make an impact through strategic and scientific input as well as scientific support of Idera’s clinical programs. He/she will use their scientific knowledge and experience to help Idera build clinical expertise in the Oncology therapeutic area.

     
    More specifically, this role collaborates with the Oncology Medical Lead and others on the team to design, plan, and implement the overall direction of clinical research projects including writing protocols, informed consent documents, Investigator’s Brochures. This individual will also coordinate activities to ensure compliance with protocol and overall clinical objectives as well as evaluate and analyze clinical data.

    Responsibilities

    30%

    • Contribute to the design of clinical studies in close collaboration with the Medical Lead as well as the entire Clinical Development team.
    • Write and coordinate finalization of clinical study documents (e.g., protocols, informed consent documents, and clinical components of investigator brochures) in compliance with regulatory standards.
    • Write draft manuscripts (paper, abstracts, posters, etc.) review and summarize relevant literature.
    • Organize expert panel, consultant, or advisory board meetings as appropriate to provide input to clinical plans
    • Provide clinical input to CRF design, statistical analysis plan, and drug supply planning

    30%

    • Collaborate with Clinical Operations in the identification and, evaluation, and selection of clinical sites and investigators, with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a time- and cost-effective manner.
    • Participate in site initiation visits as needed
    • Write protocol amendments, as necessary, to address safety, efficacy, or operational issues
    • In collaboration with Clinical Operations and the Medical Lead, Review protocol deviations (PD) reported by sites to identify cause and appropriate resolution. Review PD trends and take appropriate actions, as needed.

    25%

    • Perform clinical data review and analysis of study results
    • Work with biometrics and other clinical team members in the review and interpretation of data
    • Assist in preparation of clinical content of regulatory submissions / documents / meetings
    • In collaboration with the Communications team, responsible for the preparation of abstracts, posters, presentations, and publications.
    • Present clinical trial results internally and to the scientific community

    15%

    • In collaboration with the Pharmacovigilance Lead, review and track emerging efficacy and safety data, and take actions as appropriate
    • Perform and document regular review of individual subject safety data, and perform review of cumulative safety data with the Pharmacovigilance

    Qualifications

    Key Attributes

    • A high sense of urgency and personal initiative
    • A commitment to quality and excellence.
    • Strong scientific writing skills
    • Ability to work proactively and independently.
    • Effective verbal and written communication skills in relating to colleagues and associates both internal and external to the company.
    • Ability to work independently and successfully in a matrix environment,
    • Ability to prioritize and manage multiple tasks simultaneously.
    • Strong influence management, collaboration, and relationship building skills.
    • Detail oriented and ability to demonstrate.
    • Resilient and tenacious with courage to challenge.
    • Highly analytical and strong problem solving skills.

    Education & Experience Requirements

    • RN, MS, PhD or PharmD, with clinical research experience and a strong knowledge of drug development, or equivalent strongly preferred.
    • At least 3 - 5 years of technical operational experience in all phases of clinical trial planning, start up, conduct, reporting and publishing required.
    • Experience in clinical oncology is required.
    • Extensive, direct knowledge of the clinical development process with the ability to understand concepts of various phases and principles of study design is required.
    • Experience with interacting with medical monitors, development operations) and clinical investigators
    • Thorough understanding of ICH, GCP, and relevant regulatory requirements is required.

    Key Interactions

    • Internal- Medical Lead, Drug Safety Lead, Clinical Trial Manager, Biostatistics, CMC, Medical Writing, and other members of the cross-functional clinical development team
    • External- Site investigation and related staff; CROs

    Other Job Requirements

    • 10-20% Travel may be required

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