Director Clinical Research - Alldus

Job Title:

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.

Alldus

05/16/2024

All cities,CA