Director, Clinical Scientist (Respiratory indications)
G
Generate BiomedicinesBiotechnology
Remote (U.S.) optional with travel to HQ based on business needs.Full-TimeDirector
Salary$186,000 — $270,000 USD
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Job Details
- Experience
- 9+ years
- Required Skills
- Data AnalysisGCP
Requirements
- Advanced degree (PhD, PharmD, MD, MS, PMP).
- 9+ years of industry experience in clinical development.
- Direct experience in late-stage respiratory (asthma and/or COPD) studies.
- Strong knowledge of clinical research methodologies.
- Expertise in regulatory guidelines and Good Clinical Practice (GCP).
- Proven ability to lead clinical science strategy and execution in late-stage trials.
- Experience authoring clinical protocols, Clinical Study Reports (CSRs), and regulatory documents.
- Excellent analytical, communication, and cross-functional collaboration skills.
Responsibilities
- Serve as clinical science lead and core member of clinical development team for respiratory studies.
- Support day-to-day study execution, ensuring alignment with protocol and regulatory requirements.
- Design and develop clinical trial protocols, data review plans, and case report forms.
- Drive development of clinical components for regulatory documents including IBs, CSRs, and briefing books.
- Collaborate with cross-functional teams and external partners on medical monitoring to ensure data quality and patient safety.
- Contribute to internal governance meetings and support publication plans.
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