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Scientific. Clinical. Software Engineering

Senior Clinical Project Scientist (Respiratory & Immunology)

Maryland All, MD

Job Type: Clinical Job Number: JN -062020-26976 Region: Maryland All

Job Description

Summary:

  • Provide scientific and clinical input to all aspects of late stage product development
  • This includes but is not limited to the, design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of products in Respiratory and Immunology therapeutic area (TA) in late stage development
  • Seek input from the appropriate functional experts and will coordinate these activities in support of clinical studies and programs
  • Ensure that the safety evaluation process for the pivotal phase III trials is seamless and complete
  • The role will have a special focus on late stage clinical trials within the Respiratory and Immunology TA working in close collaboration with the study team physician and other stakeholders with all aspects of scientific input, clinical data quality metrics and safety evaluation
  • Must possess the ability to work across a highly matrixed environment to advance clinical drug development programs from target identification/validation through IND enabling activities
  • Work as a member of a diverse and motivated team of researchers spanning across multiple divisions of Biopharmaceuticals R&D
  • Lead independently activities and contribute to regulatory submissions, process improvement and mentoring

Typical Accountabilities:

  • Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs
  • Effectively collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations, and early development groups
  • Be involved primarily in late stage (Ph2b and Phase 3) clinical programs, but will be expected to collaborate with clinical colleagues supporting early stage programs as well as medical affairs colleagues
  • Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities
  • Provide expert scientific analysis and interpretation of data from ongoing studies and in the literature
  • Lead development of quality metrics and data review plan for assigned studies
  • Support and contribute to medical monitoring of trials
  • Lead and participate in activities that ensure quality, consistency and integration of clinical study related deliverables and ensure safety evaluation process within the clinical team
  • Ensure scientific input to TA standards
  • Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments
  • Present protocol and scientific results to multidisciplinary teams and key stakeholders
  • Lead development of quality metrics and data review plan for assigned studies
  • Develop and review protocols, informed consent, investigator s brochure and other clinical development documents
  • Organize and analyze data from clinical research to build new hypothesis

Requirements:

  • Scientific Doctoral Level Degree (e.g. PhD or PharmD) with at least 5 years of Clinical Science/Development experience from a sponsor company
  • Respiratory and/or Immunology Clinical Science experience is required
  • Understanding of scientific and clinical issues related to the design and implementation of clinical trials and interpreting trial results particularly in Respiratory and Immunology clinical development
  • Proven ability to work collaboratively in a cross-functional setting
  • Experience, particularly Phase II and Phase III clinical development and experience with regulatory submissions, life cycle management, advisory boards, annual safety updates


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