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.:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

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.: