Kolltan Pharmaceuticals, Inc. Work Values

Daily Duties at Kolltan Pharmaceuticals, Inc.:

Project Management Establish sites participating, completion of final site selection/training and release of study drug. First in human product. Oversight of each site, enrollment, careful assessment of subject eligibility pre-dosing, discussions with site and Medical Monitor as necessary, subject status post treatment, discussion with MM with regards to tolerance and adverse events. Interactions with site staff and Principle Investigators throughout the project. Oversight of CRO managing SAE reporting and the trial study files. Oversight of CRO management of site monitoring visits, communication with CRAs in the field. Participation in site visits as necessary. Lead weekly update teleconferences with sites, inclusive of Medical Monitor (MM), Principle Investigators (PI) and study staffs to discuss cases and issues/events and to determine next dosing level of this intravenous biologic agent, for treatment in Oncology, specifically for subjects failing all current treatments available. Recorded all meetings, interactions with site staff and PIs, during the course of the project. Kept CRO updated on all protocol changes, need for revisions in the protocol/informed consent and subject tolerance issues. Dosing decisions were discussed with the site investigators and finalized at these teleconferences then disseminated by myself to sites/PIs and the CRO. Protocol revisions were frequent along with the ICF. Treatment cycles remained stable throughout the project but dosing was adjusted due to tolerability issues. This created numerous protocol revisions/amendments.

What they like about Kolltan Pharmaceuticals, Inc.:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

Clinical Research, Oncology, Immunology, Neuroscience, CRA, Registered Nurse, Clinical Manager, Data Management, Clinical Oversight, Project Management, CRO, CRO Oversight, GCP, ICH, Pharmaceutical Industry, Clinical Site Management, Compliance, Safety Management, Site Selection, Regulatory Compliance, Continuous Quality Improvement, Medical Writing, FDA Reporting, Trial Master File/eTMF, Cross-Functional Facilitation, Strategic Planning, Risk Analysis, Safety Oversight and Reporting, Data Targeted Review

Skills

Team Leadership, Clear, Concise Communication, Think "outside the box", Creativity, Problem Resolution, Evaluation With Recommendation, Teamwork, Provide Feedback, Listening Skills

These are some of the questions we asked our climbers about their experiences with Kolltan Pharmaceuticals, Inc.: