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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Spectraforce Technologies
Oct 08, 2025