Clinical Research Scientist
1 day ago
We are seeking a highly skilled Clinical Research Scientist to join our team at Lifelancer. As a key member of our clinical research team, you will contribute to the design, conduct, analysis, and reporting of clinical trials.
Key Responsibilities:
- Collaborate with the VP of Clinical Development to review, interpret, and communicate scientific data related to the efficacy and safety of compounds in development.
- Work closely with the clinical trial manager and clinical operations manager to develop and execute clinical study strategies.
- Stay up-to-date with the latest developments in your therapeutic area through congress attendance and literature review.
- Contribute to the development of program strategy, including clinical development plans, product lifecycle plans, and target product profiles.
- Assess the competitive landscape and identify business development opportunities.
- Provide scientific and clinical study support from start-up to clinical study report and publications.
- Engage in scientific education of internal and external stakeholders on pre-clinical and clinical data relevant to the program.
- Build relationships with opinion leaders to foster research collaborations and pipeline awareness.
- Contribute to the creation of study protocols, investigator brochures, clinical study reports, informed consent forms, briefing documents, and regulatory documents.
- Collaborate cross-functionally to create a scientific platform in support of the regulatory, commercial, and medical education strategy for late-stage assets.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, and quality standards in conducting research.
Requirements:
- Advanced degree in Sciences (PharmD, PhD, RN) preferred, but not required. Advanced MS degree with experience will be considered.
- Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
- Ability to provide input and direction to clinical research with appropriate supervision.
- Strong desire to collaborate in a cross-functional setting.
- Knowledge of clinical trial methodology, regulatory, and compliance requirements governing clinical trials.
Work Environment:
- Dynamic, interactive, fast-paced, and entrepreneurial environment.
- The position is flexible for remote work.
- Domestic travel required (up to 10%).
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