Clinical Scientist

Halozyme Therapeutics   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 104 days ago

POSITION SUMMARY:

The Clinical Scientist integrates scientific drug development knowledge to ensure excellence in development and translation of clinical research plans into efficiently implemented clinical trial protocols. The Clinical Scientist is responsible for working collaboratively with the study Medical Director and other members of the SET (Study Execution Team) to establish efficient trial data review, trial document review and trial execution for one or more protocols in Phase I-III oncology clinical trials.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

  • Provide supportive for the scientific conduct of protocols and assist the study Medical Director with the scientific conduct of clinical studies for a single trial or across multiple phase I-III clinical trials
  • Support initial review of clinical data in the clinical database by conducting clinical data review, analysis and interpretation
  • Work with Clinical Operations and Data Management in database review, query and clean-up activities in real-time and prior to database lock
  • Support the study Medical Director in developing, amending clinical study protocols and actively participates in defining the key clinical components and elements of the clinical protocols
  • Support the Medical Director in updating clinical development essential documents like (but not limited to) clinical sections in: IB, IND, ICF, Annual Reports, CSR, patient narratives and other clinical documents, and maintaining those documents, in accordance to GCP, and to highest levels of quality and accuracy.
  • Work in collaboration with the Medical Director to help address questions and queries from sites and CROs
  • Provide the Medical Director and SET  with relevant clinical data, key developments and updates from the national, international and academic symposia and conferences for one or more indications and/or clinical trials
  • Provide literature based clinical data, and epidemiology-based data that support study design, study execution and study results analysis for one or more clinical protocols
  • Work in collaboration with Medical Director in preparation of meeting materials needed for strategy decisions at relevant teams, governance, external consultants, KOLs and potentially regulatory meetings
  • Support SIVs, and site training activities, in close collaboration with Clinical Operations, CROs and MSLs

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

  • Support Halozyme’s SET, Medical Director and Clinical Operations in identifying and managing critical path activities such as selection of countries and sites
  • Support the Medical Director and Data Management in CRF development, EDC system development, study portal setup, and study monitoring activities
  • Review ongoing PK, PD, safety and efficacy real-time data in electronic databases.
  • Responds and contributes to novel study designs
  • Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

  • Minimum Masters’ degree in Nursing (MSN) or PharmD with at least 8 years’ experience in clinical research in biotechnology or pharmaceutical settings and 2+ years’ as a clinical scientist (equivalent combination of clinical experience and education may be considered)
  • Demonstrated ability to review and summarize clinical trial data,  including experience in preparing and presenting data
  • Hands-on experience performing systematic literature search, summarizing the search results and presenting the conclusions to wide spectrum of audience
  • Successful track record interpreting clinical data for individual patients and aggregate data, making conclusions and presenting the results
  • Demonstrated effective oral and written communication skills and excellent interpersonal skills
  • Proven ability to perform the essential role duties with key cross functional team members within Halozyme (e.g. Biostatistics, Clinical Operations, Data Management) and with Halozyme service providers (i.e. CROs)
  • Self-directed desire and ability to work independently, proactively and efficiently in a fast-paced dynamic environment
  • Demonstrated ability to work collaboratively in a matrixed environment with wide spectrum of cross functional team members
  • Working knowledge and experience in clinical trial design is preferred
  • Hem/Oncology experiencepreferred but not required

TECHNICAL KNOWLEDGE REQUIRED:

Equipment:   PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained.  Knowledge of other equipment required: N/A

Software Knowledge:  Windows, MS Office (Outlook, Word, Excel).  Knowledge of other software required: N/A

INTERNAL AND EXTERNAL RELATIONSHIPS:

  • Data Management and Statistics, Safety and Pharmacovigilance, Clinical Operations, and Medical Writing groups Vendor, CRO and external partnerships

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