Job description

Scismic is supporting the growth of a clinical-stage, targeted oncology company in Boston, MA!

We have an exciting new opportunity for someone to join a growing clinical team as Clinical Scientist. In this role you will provide scientific and clinical expertise to support the development of our clinical programs, protocols, and all required study and regulatory documents. Reporting to our VP, Clinical Development you will provide scientific and clinical expertise to develop, design, conduct, analyze, and report global clinical trials in accordance with approved clinical development plans and European and FDA requirements.

Your Role

• You will be responsible for oversight of trials in start-up, conduct, and close-out, for Phase I-III
• Conduct regular data/safety/efficacy reviews and look for trends across programs
• Participate with study team at FDA and other regulatory meetings
• Contribute to the development of study documents for activities around study conduct (e.g., protocols, IBs, eCRFs, meeting abstracts, manuscripts, RECIST/IWG training materials), regulatory requirements (e.g., briefing documents), and IDMCs (e.g., charters)
• Contribute to strategic development decisions and plans for investigational programs
• Work with statisticians to develop the required TLFs and contribute to the interpretation of efficacy and safety data from the company's clinical trials
• Present safety findings and study status internally at meetings (e.g., safety working group/senior management meetings)
• Coordinate presentations at IDMC meetings, and other meetings, such as Investigator and Safety Review Meetings
• Provide coaching/training to new clinical scientists and company interns
• Participate in various initiatives and duties as required by the clinical development program
• Additional duties and responsibilities as required

Your Background

• You will bring a PhD in life-sciences and 3-5 years clinical research and drug development within the pharmaceutical industry. Master’s degree in life sciences considered with extensive experience as a clinical scientist
• Prior drug development experience in oncology required
• Proven experience in developing effective relationships with key investigators and KOLs
• Knowledge of GCP/ICH, study design, statistics, and clinical operations required
• Experience writing, editing, and reviewing protocols, informed consent templates, study manuals, conference presentations, and journal publications
• Team oriented, goal-driven, organized, and highly collaborative
• Excellent written and oral communication skills

Job Type: Full-time

Schedule:

• Monday to Friday

Work Location: One location

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