Associate Director, Clinical Science

• Support the design and implementation of early and late-stage clinical projects and ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous

• Develop and maintain clinical development plans that integrate preclinical, translational, and clinical data while ensuring alignment across cross-functional teams

• Design scientifically rigorous, operationally feasible, and cost-effective clinical protocols aligned with the overall clinical development plan

• Present clinical protocols, development plans, and study updates to internal governance committees and senior leadership

• Serve as the Clinical Science representative on cross-functional project teams

• Partner closely with the Medical Monitor to oversee study conduct, monitor study progress, and ensure protocol compliance

• Lead data review, evaluation, and analyses in collaboration with Data Management and Biostatistics and Statistical Programming teams

• Contribute to the preparation of clinical sections of regulatory submissions and supporting documents, including INDs, briefing documents, BLAs, Safety and Annual reports, and responses to regulatory agencies regarding questions about clinical development issues (e.g., safety or efficacy)

• Ensure compliance with applicable regulations, clinical R&D policies, SOPs and quality standards

• Support scientific due diligence activities, including preparing and presenting medically-sound strategies and plans associated with advanced opportunities

• Drive continuous improvement to enhance Clinical Development processes, study execution and cross-functional collaboration

• PharmD or PhD with 7+ years of clinical science experience in a biotech or pharmaceutical company, or CRO environment
• Experience in clinical development and/or translational science required
• Strong understanding of clinical trial design, data collection standards, and GCP guidelines
• Strong analytical skills with the ability to analyze and compile complex clinical data
• Strong experience working with vendors and clinical sites
• Excellent communication and collaboration skills with both internal teams and external partners
• Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
• Excellent oral and written communication skills, including proficiency with Excel and Power Point

Demonstrates expertise in clinical development and translational science, with a strong focus on clinical trial design, regulatory submissions, and cross-functional collaboration. Proven ability to lead data analysis and ensure compliance with GCP guidelines and clinical R&D policies.

• Clinical Development Experience
• Clinical Trial Design
• Regulatory Submissions
• Data Analysis
• Cross-Functional Collaboration

• Clinical Science
• Clinical Protocol Development
• Data Collection Standards
• GCP Guidelines
• Analytical Skills
• Clinical Development Plans
• Study Execution
• Regulatory Compliance
• Translational Science
• Vendor Management

• Excellent Communication
• Collaboration Skills
• Leadership Skills

• PharmD
• PhD

• Biotech
• Pharmaceutical
• CRO
• Clinical R&D
• SOPs
• Safety Reports
• Efficacy

• Excel
• Power Point