Company: Confidential
Job Title: Director Clinical Science
Job Number: 89193
Location: Remote, US
Job Description
The Director, Clinical Science, plays a key role in the scientific, clinical, and operational facets of clinical development programs, focusing on program-specific activities. This role involves leading the design, planning, and implementation of study protocols and providing critical support for regulatory activities. The Director actively collaborates with cross-functional teams to develop and oversee study management teams, ensuring the effective design, execution, and monitoring of clinical trials. Responsibilities also include assisting with data interpretation, engaging with internal and external stakeholders, and driving process improvements within the clinical department.
Responsibilities
Collaborate with cross-functional teams to manage clinical study operations, ensuring feasibility, data management, communication plans, safety monitoring, and study closure. Conduct medical and safety data reviews, analyzing trial data to identify issues and communicate findings. Support Data Monitoring Committees through updates, data reviews, and synthesized reports. Author protocols and contribute to various clinical and regulatory documents. Engage with stakeholders to support program strategies and clinical objectives, responding to queries and escalating as needed. Act as a clinical expert, contributing to scientific publications, conferences, and investigator meetings. Oversee junior clinical scientists and perform literature reviews when necessary.
Required Skills
* Education: PhD in health sciences, PharmD, or MD (or non-U.S. equivalent). * Experience: Minimum of 8 years in Clinical Science within a CRO or biotech setting, with specific expertise in oncology clinical trials and late-stage drug development. * Skills: Proficient in data analysis, safety, and pharmacovigilance, with strong ability to interpret complex scientific data to support hypothesis generation and development strategy. Knowledgeable in biostatistics, GCP, and regulatory standards for clinical trialsSalary range 235-260k/yr expected range
Application Deadline: 2024-12-30
To apply for this job please visit jobrxiv.org.