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Clinical Scientist

Clinical Scientist

Spectraforce TechnologiesWaltham, MA, United States
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Position Title : Clinical Scientist II

Assignment Duration : 6 months (Possible Extension)

Work Arrangement : Hybrid (preferred onsite in Boston / Waltham, MA 02451. If not, must be able to commute - Chicago, IL 60064 or South San Francisco, CA 94080.

Position Summary :

  • Contribute to the review , interpretation , and communication of scientific data pertaining to the efficacy and safety of compounds in development

Qualification & Experience :

  • Bachelors degree in sciences ; advanced degree (e.g., MS , PhD , PharmD ) preferred
  • Ability to provide input and direction to clinical research with appropriate supervision
  • Strong desire to collaborate in a cross-functional setting
  • Clinical trial experience in the pharmaceutical industry , academia , or equivalent preferred
  • Knowledge of clinical trial methodology , regulatory and compliance requirements , and experience in the design of study protocols

    • Required Skills :

  • Oncology clinical trial experience in solid tumors in the pharmaceutical industry
  • Hands-on experience with data review , data cleaning , data analysis , and extensive experience using EDC , CTMS , and other databases
  • Contribute to the scientific content of Study Protocols , Investigator Brochures , Clinical Study Reports , Informed Consent Forms , briefing documents , charters , and regulatory documents
  • Excellent written and verbal communication skills , detail-oriented organization skills , and team collaboration skills

    • Experience Level : 3-5 Years

    Key Responsibilities :

  • Attend congresses and review literature to develop and augment expertise in therapeutic area
  • Help develop program strategies including the clinical development plan , product lifecycle plans , target product profiles , and draft labels
  • Review competitive landscape and help identify and evaluate business development opportunities
  • Provide focused scientific and clinical study support from start-up clinical study report (CSR)
  • Participate in scientific education of internal and external stakeholders on pre-clinical (e.g., mechanism of action , animal models ) and clinical (e.g., epidemiology , diagnosis , treatment ) data relevant to program
  • Engage in opinion leader interactions to build pipeline awareness and foster research collaborations
  • Contribute to the scientific content of Study Protocols , Investigator Brochures , Clinical Study Reports , Informed Consent Forms , briefing documents , charters , and regulatory documents
  • Contribute to creation of electronic database , IRT , and associated training documents ; review data completeness and fidelity throughout study conduct
  • Collaborate cross-functionally to create a scientific platform in support of regulatory , commercial , and medical education strategy for late-stage assets
  • Ensure adherence to Good Clinical Practices , pharmacovigilance standards , standard operating procedures , and other quality standards in conducting research
  • Contribute to authorship of regulatory responses and participate in meetings
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    Clinical Scientist • Waltham, MA, United States

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