Company
Biotech
Director,ClinicalScience
Neural analysis suggests this role is
optimal for Director candidates.
“Director, Clinical Science. Support design of clinical studies. Implement clinical studies”
Industry & Context.
Willingness to travel domestically and internationally
What They're Looking For.
Must Have
Advanced degree required (PhD, PharmD, and/or MD), 6–8+ years of experience in pharmaceutical or biotechnology industry, Experience in academic or clinical research settings, Excellent ability to interpret, synthesize, and communicate complex clinical and scientific data, Organizational skills, Ability to manage multiple priorities, Exceptional written communication skills, Exceptional verbal communication skills, Interpersonal skills, High attention to detail, Adaptability, Flexibility
Nice to Have
Experience in nephrology, Experience in rare disease, Exposure to early-phase studies, Knowledge of regulatory processes, Prior involvement in INDs, Prior involvement in NDAs, Prior involvement in BLAs, Prior involvement in regulatory submissions
What You'll Do.
Support design of clinical studies
Implement clinical studies
Contribute to analysis of data
Contribute to interpretation of data
Contribute to reporting of data
Lead preparation of clinical documents
Lead preparation of study reports
Lead preparation of regulatory submission components
Lead preparation of protocols
Lead preparation of SAPs
Lead preparation of briefing books
Lead preparation of clinical summaries
Ensure compliance with GCPs
Develop scientific materials
Present scientific materials
Build relationships with external collaborators
Maintain relationships with external collaborators
How You'll Work.
Team & Collaboration
Cross-functional teams; External collaborators; Investigators; Alliance partners; Key opinion leaders; Multidisciplinary teams; External stakeholders
Communication Scope
Scientific data communication; Presenting at scientific forums; Presenting at medical forums
Process & Methodology
Project management
Full Job Description
## Accountabilities Support the design and implementation of clinical studies, including human pharmacology studies, ensuring scientifically sound methodologies and alignment with development objectives. Contribute to the analysis, interpretation, and reporting of clinical trial data for safety, efficacy, and mechanism of action insights. Lead the preparation of clinical documents and deliverables, including study reports, regulatory submission components (INDs, NDAs, BLAs), protocols, SAPs, briefing books, and clinical summaries. Ensure compliance with Good Clinical Practices (GCPs) across study design, execution, and documentation activities. Collaborate with cross-functional teams including statistics, clinical operations, and regulatory affairs to support data analysis, interpretation, and submission readiness. Develop and present scientific materials such as conference presentations, manuscripts, and clinical trial registry summaries. Build and maintain strong relationships with external collaborators, including investigators, alliance partners, and key opinion leaders to support clinical development activities. Requirements: Advanced degree required (PhD, PharmD, and/or MD) in a relevant life sciences discipline; specialization or experience in nephrology or rare disease strongly preferred. 6–8+ years of experience in the pharmaceutical or biotechnology industry, or equivalent experience in academic or clinical research settings. Demonstrated experience in clinical trial design, execution, and analysis, including exposure to early-phase (human pharmacology) studies preferred. Strong knowledge of regulatory processes and prior involvement in INDs, NDAs, BLAs, and regulatory submissions highly desirable. Excellent ability to interpret, synthesize, and communicate complex clinical and scientific data. Strong organizational and project management skills with the ability to manage multiple priorities in a fast-paced, cross-functional environment. Exceptional writte
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