KAI Research, Inc. is currently seeking a Director, Clinical Research (DCR) to join the senior management team. This position will report to the President of KAI Research, and will work with the leadership team and colleagues in the delivery of company objectives. The DCR will provide technical, scientific and business development guidance for and conduct implementation of clinical research and related support services and provide project or portfolio direction and management.
• Works closely with the KAI Research, Inc. senior management team to plan, direct, review and implement all aspects of organization's strategic objectives, clinical research implementation, business development, and policies/SOPs.
• Serves as liaison with outside medical and scientific experts; interacts with company clients; participate as technical expert for strategic or marketing decisions. Attends conferences to represent KAI and actively market KAI’s services. Meets with prospects to present KAI’s capabilities and value proposition.
• Lead, direct or provide subject matter expertise, general oversight, monitoring, guidance, and quality assurance for planned and ongoing projects/studies and implementation of clinical research regulations and policies.
• Coordinates and manages the development of general and study specific guidelines.
• Develops, designs and implements clinical trial protocols, informed consent forms and CRFs for Phase I-IV clinical trials, and interfaces with principal investigators.
• Confers with biostatistician to assess and makes recommendations to clients on statistical issues including statistical analysis plan, randomization scheme, safety monitoring and reporting characteristics for client sponsored clinical trials.
• Provides leadership and participates in writing and editing of clinical study reports, draft presentations and manuscripts, and other research, scientific and technical documents.
• Advise on best practices for DMCs/DSMBs.
• Provides review, analysis, and categorization of clinical studies, and grants for clients.
• Interview and hire research support staff; Responsible for resource allocation and development of assigned research staff; Reviews and approves timesheets; Evaluates employee performance.
• Guide and lead clinical research management teams, coordinate research staff, and ensures appropriate integration of cross-functional team members to achieve project objectives and meet budget goals.
• Lead the troubleshooting process to reach resolutions for any issues that arise during course of a study.
• Create department processes and procedures documentation in order to support continuous project quality and portfolio management.
• Identify and qualify opportunities for KAI within government and commercial business sectors, present to senior management team for review, and participate in business development go/no go decisions. Lead and participate in the writing of proposals and bid defense. Provide background information and determines tasks, schedules, and resources.
• PhD or MD/PhD in Health Sciences.
• Certification in Clinical Research (CCRA, CCRI, RAC) preferred.
• Six to ten years’ experience in the drug or device clinical research process that includes, but not limited to study design, budget development and management, clinical research project management with multi-site trials, data analysis, regulatory requirements and scientific writing.
• Demonstrates expertise in a variety of the industry's concepts, practices, and procedures, including experience in interactions with FDA, regulatory agencies and the medical/scientific community.
• Excellent written and verbal communication skills, with medical writing experience preferred.
• General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data.
• Ability to work independently and work with a matrix team environment required.
• Leadership, supervisory and talent development experience.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies.
• Ability to build and maintain good working relationships with a diverse array of clients.
• Approximately 0-10% travel requirement for this position.
About KAI Research, Inc.
KAI Research, Inc., an Altarum company, is a contract clinical research organization (CRO) and health research company. Since 1986, we’ve helped pharmaceutical, academic, and federal clients accelerate time to market for innovative drug treatments, devices and other interventions. We have supported several federal clients for multiple decades and coordinated hundreds of clinical trials and epidemiological studies in a wide variety of therapeutic areas.
Using a collaborative, “high touch” and “high integrity” approach, we offer a wide range of clinical research services, including study management, observational studies and registries, patient recruitment and site partnerships, regulatory affairs, data management and eClinical solutions, monitoring, clinical safety, statistical support, and quality assurance. Our decades of experience allow us to predict needs, avoid common barriers, and move from a quick startup through each research phase.
KAI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.