Director, Clinical Scientist (Respiratory indications)
Related skills
gcp biostatistics late_stage_trials clinical_study_plans๐ Description
- Serve as clinical science lead for respiratory studies (asthma and/or COPD).
- Support day-to-day study execution, ensuring protocol and regulatory alignment.
- Lead late-stage protocol design and regulatory docs (IBs, CSRs, briefing books).
- Participate in medical monitoring to ensure data quality and participant safety.
- Support site selection, initiation, and investigator engagement.
- Track study progress and identify risks to timelines or data integrity; coordinate with CROs and vendors.
๐ฏ Requirements
- Advanced degree (PhD/MD/PharmD/MS/PMP) with 9+ years in clinical development, incl. late-stage respiratory studies.
- Strong knowledge of clinical research methods, regulatory guidelines, and GCP.
- Proven ability to lead clinical science strategy and execution in late-stage trials.
- Excellent analytical, communication, and cross-functional collaboration skills.
- Experience authoring clinical protocols, CSRs, and regulatory documents.
- Nice to Have: small molecule and biologic modalities; AI/ML driven drug discovery platforms; BLA/MAA submissions.
๐ Benefits
- Annual bonus, equity compensation, and a competitive benefits package.
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