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Job Details

Requisition Number 19-0020
Post Date 4/23/2019
Title Clinical Research Scientist
City Westlake Village
State CA
Description

Through the application of scientific and clinical training and expertise, the Clinical Research Scientist (CRS) is an integral member of the clinical development team for strategic and operational planning for Phase 1 through 3 development plans and clinical study protocols. The CRS may also work closely with pharmaceutical research on Early Phase I Clinical Pharmacology projects and Medical Affairs on scientific disclosures, presentations and thought leader interactions.  Specific activities may include developing or contributing to the clinical/medical plan, the development, conduct and reporting of clinical trials; the implementation of clinical trials in partnership with Clinical Research Organizations (CRO); writing and review of study reports; publications and data dissemination; NDA/BLA submissions and contacts with regulatory agencies.

The Clinical Research Scientist serves as a scientific resource and must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), and Good Clinical Practices (GCPs).

Essential Duties and Job Functions:

  • Acquires and utilizes knowledge of clinical trial design to develop specific study synopses and protocols.
  • Stays abreast of new developments in diabetes treatments and devices, and competitive products and experimental compounds.  May also participate in competitive analysis in other disease states to support early phase pipeline candidates.
  • Participates/leads protocol review discussions concerning scientific and procedural aspects of study design.
  • Collaborates with key thought leaders to solicit input into protocols and other strategic development questions.
  • Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
  • Leads planning for Investigator meetings and presents compound and protocol overview at meetings.
  • Contributes to the design and development of clinical data collection forms, Data Management Manuals and Data Analysis Plans.
  • Addresses questions regarding scientific and related procedural issues from Investigators.
  • Provides scientific and operational leadership and oversight of vendors and CROs.
  • Helps identify and assess clinical sites for study participation.
  • Monitors real-time study data to ensure study compliance and patient safety.
  • Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
  • Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs. 

 

Requirements

Education and Experience Qualifications:

  • Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
  • Typically requires a higher degree such MS, PharmD or PhD and experience in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization or academic institution.
  • Experience in clinical protocol development, clinical study conduct, and data interpretation preferred.
  • Knowledge and experience within diabetes therapeutic area preferred.
  • 7+ years of relevant clinical drug development experience with MS degree.
  • 3-5+ years of relevant clinical drug development experience with a PharmD or PhD.
  • Demonstrated ability to be a fast learner.
  • Demonstrated ability to analyze and interpret data and communicate conclusions clearly and concisely to audiences with varying levels of scientific expertise.
  • Demonstrated ability to work effectively within multidisciplinary teams.
  • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
  • Experienced with Microsoft Office (Excel, PowerPoint, etc.)

Mannkind Corporation is proud to be an Equal Employment Opportunity employer. We provide equal employment opportunity (EEO) to all persons regardless of race, creed, color, religion, national origin, ancestry, gender (including pregnancy, breastfeeding or medical condition related to pregnancy or breastfeeding), age, physical or intellectual disability, sexual orientation, gender identity, gender expression, gender stereotyping, marital status, military or veteran status, citizenship, genetic characteristic or information, or any other characteristic protected by applicable federal, state, or local law.

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