- Ensures that clinical trial projects are properly resourced, managed, and executed within budget and in accordance with established timelines and quality standards.
- Serves as the lead manager for review of protocols, amendments, CRFs, informed consent forms, operations, and other documentation required for conduct of clinical trials.
- Maintains, manages, reviews, and approves internal clinical trial files, technical documents, and articles including specification, test results, protocols, reports, and investigations from contractors and other outside organizations.
- Prepares required regulatory documents, such as annual reports, updating of the IB, and final study reports for assigned protocols.
- Manages the day-to-day clinical operations, including management of vendors (e.g., CRO) and coordination of activities.
- Participates in investigator meetings and follows up as needed.
- Critically evaluates toxicology results and provides strategic advice to project teams and senior management on the potential impact of toxicology results on programs and Clinical/Regulatory strategies.
- Liaises with Research and Development colleagues to develop overall Safety Pharmacology and Toxicology Development Strategies for assigned programs.
- Interacts with third party vendors and CROs.
- Reviews and approves technical documents including procedures, protocols, reports, and laboratory data.
- Generates and maintains clear and detailed documentation of his/her work.
- Possesses in-depth knowledge of the basic and advanced concepts that are related to pharmaceutical development.
- Independently performs routine duties such as document review. For more complicated work, consultation with the VP of Research & Development may be necessary from time to time.
- Pharm D, PhD (Pharmaceutics or Toxicology experience preferred), MD (Pediatric experience preferred) degree or equivalent is required.
- Minimum of 5 years experience in clinical research is required.
- Minimum of 3 years direct experience in planning and managing clinical trials is required.
- Strong working knowledge of medical terminology, physiology, pharmacology, and pharmaceuticals are required.
- Solid understanding of the pharmaceutical clinical development processes is required.
- Significant experience with responsible roles in the conduct or management of clinical trials is required.
- Exceptional knowledge of applicable U.S. and international Regulatory requirements and guidelines are required.
- Regulatory (FDA) experience is preferred.
- Familiarity with global clinical trials is preferred.
- Proficiency in Microsoft Office applications (i.e., Outlook, Word, Excel, PowerPoint, and Access)
- Superior attention to detail.
- Excellent verbal and written communication skills, including facilitation of group presentations.
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Clinical Director - Flowery Branch, United States - Kiel Laboratories, Inc.
3 weeks ago
Description
Overview:
Kiel Laboratories is a pharmaceutical research and development company located in Flowery Branch, GA. Kiel's core competencies include CMC Research and Development, Quality Assurance, Regulatory Affairs, Clinical Development, Business Development, and Outsourcing. As a pharmaceutical research and development firm, Kiel has been responsible for bringing over ten products from concept to licensure over the past ten years.
The Clinical Director will manage all aspects of clinical development including Phase I to Phase IV studies with primary emphasis on BA/BE studies. The Clinical Director will be the primary contact for external CROs and be responsible for protocol development, oversight of specific studies including data collection and safety (adverse event reporting), GCP adherence to protocols, and review approval of final clinical study reports. The Clinical Director will also be responsible for the development of budgets for specific studies.
Essential Duties:
Working independently with minimal supervision, the Clinical Director:
Other Duties:
The Clinical Director will manage proper communication with internal departments to maintain good relationships in connection with matters related to clinical trial projects. The Clinical Director:
Work Environment:
This position operates in both a professional laboratory setting as well as an office/business environment. This role also routinely utilizes standard office equipment, such as computers, telephones, photocopiers, and email.
Position Type/Expected Work Hours:
This is a full-time position. Workdays and hours are as follows: Monday through Friday, 8:00am – 5:00pm. Overtime and weekends may be required.
Travel Requirements:
Domestic and international travel required up to 10-20%.
Educational & Experience Requirements:
Kiel Laboratories, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origins, disability status, genetics, protected veteran status, sexual orientation, gender, identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
