Director Clinical Research - California, United States - Alldus

Description

Job Title:

• Director of Clinical Research

Job Summary:

• The Director of Clinical Research is responsible for leading and managing all aspects of clinical research initiatives within the organization.
• This role involves strategic planning, protocol development, project management, staff supervision, and ensuring compliance with regulatory standards.
• The Director collaborates with cross-functional teams to drive clinical trial execution, manage budgets, and contribute to the advancement of medical knowledge and therapeutic interventions.

Responsibilities:

• Develop and implement strategic plans for clinical research programs in alignment with organizational goals and objectives.
• Oversee the design, development, and execution of clinical research protocols, ensuring adherence to ethical standards and regulatory requirements.
• Manage clinical trial operations, including site selection, investigator recruitment, patient enrollment, and data collection.
• Provide leadership and guidance to clinical research staff, including training, performance management, and professional development.
• Collaborate with internal and external stakeholders, including physicians, scientists, regulatory agencies, and vendors, to drive research initiatives forward.
• Ensure compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and other relevant regulations and standards.
• Manage clinical research budgets, including forecasting expenses, tracking expenditures, and optimizing resource allocation.
• Oversee data analysis and interpretation, collaborating with biostatisticians and other experts to generate meaningful insights.
• Facilitate the dissemination of research findings through publications, presentations, and scientific conferences.
• Stay abreast of developments in clinical research methodology, technology, and regulatory landscape to inform decision-making and drive innovation.

Qualifications:

• Advanced degree (e.g., MD) in a relevant scientific field. - MD is 100% required
• Extensive experience (typically 7-10+ years) in clinical research, with a track record of progressively increasing responsibility and leadership.
• Strong understanding of clinical trial design, execution, and regulatory requirements.
• Demonstrated leadership skills, with the ability to inspire and motivate multidisciplinary teams.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders.
• Strategic thinking and problem-solving abilities, with a focus on driving results and achieving objectives.
• Proficiency in project management tools and techniques, with the ability to manage multiple priorities and deadlines.
• Familiarity with clinical research software and electronic data capture systems (e.g., EDC, CTMS).
• Commitment to ethical conduct and integrity in clinical research practices.
• Certification in Clinical Research (e.g., ACRP, SOCRA) preferred.