Position Overview

Drive clinical and scientific activities associated with the design, conduct and reporting of clinical trials for assigned therapeutic areas, interfacing with the Regulatory, Clinical Research, R&D, and Marketing departments; and have significant interaction with executive leadership, physicians and regulatory authorities. Oversee planning and execution of clinical evaluations to support design validation and risk management activities, act as a subject matter expert and provide scientific input for development of regulatory and/or marketing strategies, and support for communications with global regulatory authorities during the complete lifecycle of MicroVention products. Job duties:
  • Responsible for development and management of the clinical sciences and medical writing team organization including processes, procedures, training, and activities that support planning, and execution of relevant departmental initiatives.
  • Lead development of sections of clinical study protocols (CSP), clinical sections of regulatory submissions/communications (IDE, PMA, 510k), clinical evaluation plans (CEP), clinical evaluation reports (CERs), post-market safety plan/reports (PMCFP/R), investigator’s brochures (IBs), clinical study reports (CSRs), and evidence papers for submission support.
  • Oversee all aspects of publication and medical communication agencies/vendors including supervision and performance management.
  • Oversee conduct of targeted scientific literature searches, analyses of clinical/scientific data and competitive information across multiple products and/or therapies within the assigned therapeutic area.
  • Partner with Global and U.S. Regulatory Affairs; provide scientific input to support development of regulatory strategies for MicroVention products including oversight of clinical content development supporting Regulatory Affairs communications and overall initiatives.
  • Drive the generation of white and position papers by evaluating scientific literature, analyzing scientific data, and staying abreast of current clinical practice.
  • Assist Medical Affairs management with direct customer interactions as needed.
  • Perform additional responsibilities as assigned.
    1. Must have a Master’s degree in a relevant science, medicine, or similar discipline with at least ten (10) years of relevant clinical, regulatory or medical affairs experience.
    2. Proven track record in authoring complex scientific documents including Clinical Study Protocols, Clinical Evaluation Reports and Clinical Study Reports.
    3. Experience in working cross-functionally internally and with external vendors and physicians in authoring clinical manuscripts for publication.
    4. Excellent writing, editing and a keen attention to detail.
    5. Strong verbal, written, and interpersonal communication skills.
    6. Clinical protocol and evaluation report development experience.
    7. Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.
    8. Proven analytical skills working with clinical or research data.
    9. Knowledge of Good Clinical Practices (GCP)
    Desired Qualifications
    1. MD/PhD degree in a relevant discipline with seven (7) years’ experience in clinical research in the medical device/pharmaceutical/biotech industry.
    2. Experience as an author or contributor of peer-reviewed manuscripts is strongly desired.
    3. Knowledge of patient safety, quality, clinical research, strategic planning, health biostatistics or epidemiology is desired.
    4. Experience interacting with U.S. and global regulatory agencies highly preferred.