28 days old

Associate Clinical Scientist

Roche
California, CA

OVERVIEW:

  • Supports PD Medical Directors/Clinical Development Physicians by providing additional guidance and direction to CSTs and other relevant teams in developing all CD plan components (e.g. analytics/data strategy, KOL development, publications strategy, etc.)
  • Supports PD Medical Directors/Clinical Development Physicians in preparing for HA meetings. As appropriate, participates in HA meetings.  Ethically, effectively and professionally represents the interests of Roche and patients
  • Provides strategic clinical science support for assigned studies and programs:
  • Leads or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and communications
  • As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
  • Collaborates with clinical operations to develop and implement the overall data quality plan
  • Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.
  • Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders.  Coordinates submissions to scientific meetings and/or other appropriate venues or groups
  • Supports PD Medical Directors/Clinical Development Physicians, regulatory and other internal partners/stakeholders with completion and submission of regulatory filings and other regulatory documentation.  Writes clinical science sections of HA meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
  • Works with PD Medical Directors/Clinical Development Physicians to drive ongoing data generation to address unmet medical needs and identify new or extended CD studies

QUALIFICATIONS & EXPERIENCE:

  • Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
  • Clinical trial experience (must demonstrate a minimum of 2 years clinical trial experience in pharma/biotech industry)
  • Data listing review experience
  • Experience authoring aspects of a global clinical development plan or full clinical study protocol
  • Has solid knowledge of clinical research and has successfully worked across Phase II â III drug development projects
  • Experience in the principles and techniques of data analysis, interpretation and clinical relevance

ABILITIES

  • Proven abilities to perform Clinical Scientist responsibilities independently and with limited guidance.  Has demonstrated, through past experience, abilities to competently manage the majority of Clinical Scientist deliverables associated with assigned clinical studies
  • Has in-depth knowledge of the multidisciplinary functions involved in a companyâs drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
  • Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with others.  Has proven experience and skills working with multidisciplinary teams

#LI-PDKM2

Posted: 2019-01-24 Expires: 2019-03-24

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Associate Clinical Scientist

Roche
California, CA

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