Associate Director, Clinical Science (Office or Remote)

Overview

The Associate Director, Clinical Science will be a key contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on program-specific activities. The Associate Director, Clinical Science will help drive the design, planning, and implementation of study protocols for assigned investigational products and will play a key role in supporting related regulatory activities. This role will work on cross-functional study management teams for the design, execution, and monitoring of clinical trials, as well as data interpretation and communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department.

In Short

• Partner with cross-functional study-level teams to help drive the conduct of our clinical studies.
• Analyze clinical trial data and provide preliminary assessments.
• Perform safety/efficacy data reviews.
• Support senior team members with medical monitoring reports and safety reviews.
• Provide organizational support for Data Monitoring Committees.
• Author clinical protocol synopsis and contribute to clinical study documents.
• Interact with internal and external stakeholders.
• Write and/or review collaborative abstracts and content for scientific meetings.
• Support publication strategy execution.
• Present at investigator meetings and site initiation visits.
• Conduct literature reviews as needed.
• Line management of junior clinical scientists.

Requirements

• PhD degree in health science field, PharmD, MD or equivalent.
• At least +5 years of experience in a pharmaceutical, CRO or biotechnology company.
• Late-Stage drug development and Phase 3 experience preferred.
• Experience in oncology or oncology immunotherapy clinical trials preferred.
• Experience with data analysis and understanding of safety and pharmacovigilance principles.
• Ability to think innovatively and tactically.
• Demonstrated ability to evaluate and present complex scientific data.
• Working knowledge of biostatistics, GCP, and regulatory requirements.
• Ability to handle multiple projects and strong attention to detail.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to make independent, timely decisions.

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.