The Clinical Scientist reports directly to the Director of Clinical Science for Oncology and will support various aspects of clinical development. This individual will participate in clinical trial design, data analysis, communication of the program, and contributions to regulatory submissions, publications, and presentations.
Position Responsibilities:
1. Support Medical Lead with medical monitoring activities, safety reviews, site interactions, and review of TFLs.
2. Perform clinical data review and analysis of study results.
3. Present clinical trial results internally and externally.
4. Collaborate with Clinical Operations and Medical Lead to review protocol deviations for cause and resolution.
5. Assist in authoring and reviewing protocols, clinical study reports, IBs, ICFs, training documents, charters, and other clinical/regulatory documents under Medical Lead supervision.
6. Provide insights on clinical/competitive trends and strategic development pathways.
7. Support preparation of scientific materials for conferences and publications.
8. Assist with advisory boards, consultant meetings, and investigator meetings, including presentation preparations.
9. Contribute to departmental and corporate objectives.
Candidate Requirements:
1. RN, PhD, or PharmD with clinical research experience and strong drug development knowledge, or equivalent.
2. Experience in oncology drug development is preferred.
3. Experience in protocol development, study report preparation, Investigator Brochure creation, and regulatory submissions is a plus.
4. Thorough understanding of regulatory guidelines (e.g., GCP, ICH, FDA) is essential.
5. Highly analytical with problem-solving, organizational, and critical thinking skills.
6. Strong attention to detail and ability to manage multiple tasks under tight deadlines.
7. Ability to work independently and collaboratively with multidisciplinary teams and external vendors.
8. Excellent written and verbal communication skills.
The company, Beacon Hill Life Sciences, is a staffing organization providing contract, permanent, FSP/outsourcing, and consulting services to the pharmaceutical, medical device, biotech, and CRO sectors. We place contractors nationwide, supporting clients from start-ups to Fortune 500 companies, matching talent with opportunities.
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