Clinical Research Scientist

As a Clinical Scientist within the Early Clinical Development Group, you will have responsibility and accountability for early clinical and clinical pharmacology programs and study implementation.

You will have an unparalleled opportunity to be involved with every aspect of the product development process, from first-in human through approval, including post-marketing activities. In this role, you will have the advantage of providing input into a breadth of products within and across your area of responsibility. We seek to provide a fun and rewarding career and a continuous learning experience.

• Provide strategic leadership and demonstrating accountability for the clinical programs supporting early clinical development and clinical pharmacology
• Maintain updated knowledge of competitive landscape on current assets or evolving standards of care for indications of interest and provide subject matter expertise on cross-functional project teams
• Author/Review/Approve clinical protocols, analysis plans, study reports and regulatory submissions in collaboration with physicians, statisticians and other critical functions.
• Execute Clinical & Clinical Pharmacology studies in close collaboration with Clinical Operations
• Review and summarize clinical safety or efficacy data in collaboration with the Medical Monitor
• Work closely with Quantitative Clinical Pharmacology, Translational Sciences and Statistics to develop protocols and summarize analysis
• Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
• Draft and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions
• Ensure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical studies and programs
• Develop and maintain collaborative working relationships with appropriate consultants and external experts for subject matter expertise and protocol development
• Compliant with departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
• Participate in project teams and serve as liaison to project teams, CRO's, Clinical sub-teams, and others
• Present data at scientific meetings, both internally and externally and author manuscripts in scientific journals

• At least 5 years’ experience and a, PhD, PharmD or MD degree or at least 10 years’ experience with BS/MS degree with emphasis on early development, clinical pharmacology or a related discipline
• Ability to critically analyze problems and provide creative solutions
• Excellent written and oral communication skills
• Confidence and ability to present to and influence matrix teams and senior leaders
• Ability to work independently, manage multiple priorities, and thrive in a dynamic environment
• Genuine curiosity and drive to ask questions - looking for the 'why' of every project
• Experience in clinical pharmacology, immunology or oncology is preferred, but not required
• Willingness to travel up to 20% or as business needs require, with accommodations available for individuals with disabilities

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.