The Clinical Scientist reports directly to Director of Clinical Scientist for Oncology and will support various aspects of clinical development.  This individual will participate in clinical trial design, clinical data analysis, internal and external communication of the program, and contributions to regulatory submissions, publications and presentations.

Position Responsibilities: 

Support Medical Lead with medical monitoring activities, safety reviews, site interactions, and reviewing TFLs. Perform clinical data review and analysis of study results. Present clinical trial results internally and externally.

In collaboration with Clinical Operations and the Medical Lead, review protocol deviations to identify cause and appropriate resolution.

Support authoring and review of protocols, clinical study reports, IBs, ICFs, training documents, charters, and other clinical and regulatory documents under the direction of the Medical Lead.

Provide feedback on emerging clinical/competitive trends; understanding competitive landscape and providing insights on strategic development pathways.

Support preparation of scientific material for conference presentations or publications.

Provide support to advisory boards, consultant meetings, and investigator meetings, including preparation and delivery of presentations.

Assist in accomplishing department and corporate objectives.

Candidate Requirements:

RN, PhD or PharmD, with clinical research experience and a strong knowledge of drug development, or equivalent strongly preferred.

Experience in oncology drug development is preferred.

Experience in protocol development, study report preparation, Investigator Brochure preparation, and regulatory submissions is a plus.

Working knowledge and thorough understanding of all relevant regulatory guidelines and standards (e.g. GCP, ICH, and FDA) is essential.

Highly analytical with strong problem-solving, organization, and critical thinking skills.

Strong attention to detail and the ability to manage multiple tasks, especially under aggressive timelines.

Ability to work individually, within a multi-disciplinary team, as well as with external vendors.

Excellent written and communication skills.