What are the responsibilities and job description for the Associate Director to Senior Director Clinical Scientist position at Kaztronix?
As an Associate Director or Senior Director Clinical Scientist within the Clinical Pharmacology Group, you will have ultimate responsibility and accountability for clinical pharmacology programs.
As a member of the Clinical Pharmacology team you will have 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.
Summary of the Essential Functions of the Job
- Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds
- Representing the department and providing subject matter expertise on cross-functional project teams
- Developing and maintaining collaborative working relationship with colleagues within and outside the department
- Authoring / reviewing / approving clinical protocols, analysis plans, study reports and regulatory submissions
- Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
- Execution of Clinical Pharmacology studies in close collaboration with Clinical Operations
- Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
- Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Participating in and collaborating with individuals from across the business in special projects
Minimum Requirements
Assoc Director 3
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.
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