Respiratory Clinical Scientist Lead, Late-Stage Trials

Generate Biomedicines; United States; Remote; USD 186.000 - 270.000; Vollzeit

Zusammenfassung

Generate:Biomedicines is seeking a Director, Clinical Scientist to lead clinical development for respiratory programs (asthma and COPD), guiding protocol design, data analysis, and regulatory documentation for Phase 2/3 trials. The role reports to the Senior Director, Clinical Development and requires an advanced degree with 9+ years in late‑stage respiratory studies.

You will collaborate across Clinical Operations, Regulatory, Biostatistics, and Safety teams, manage study milestones, monitor

Qualifikationen

• Advanced degree and 9+ years of industry experience in clinical development, including direct experience in late‑stage respiratory studies.
• Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP.
• Demonstrated ability to lead clinical science strategy and execution in late‑stage trials.
• Excellent analytical, communication, and cross‑functional collaboration skills.
• Prior experience authoring clinical protocols, CSRs, and regulatory documents.

Aufgaben

• Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD).
• Support day‑to‑day study execution, ensuring alignment with protocol, timelines, and regulatory requirements.
• Design and develop clinical trial protocols and associated documents (e.g., CSPs, CRFs, database design, SAPs) and contribute to regulatory documents (IBs, CSRs, briefing books).
• Participate in medical monitoring activities to ensure data quality and participant safety; escalate issues as needed.
• Support site selection, initiation, and investigator engagement; provide scientific support to researchers.
• Contribute to trial delivery team efforts: track milestones, identify risks, and liaise with CROs and vendors.
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment.
• Participate in governance meetings and contribute data summaries and risk assessments.
• Support inspection readiness and publication planning.

Kenntnisse

Clinical trial design

Late-stage trial execution

Regulatory guidelines (GCP)

Cross-functional collaboration

Scientific leadership

Ausbildung

Advanced degree (PhD, PharmD, MD, MS, PMP)

Jobbeschreibung

Generate:Biomedicines is seeking a Director, Clinical Scientist to lead clinical development for respiratory programs (asthma and COPD), guiding protocol design, data analysis, and regulatory documentation for Phase 2/3 trials. The role reports to the Senior Director, Clinical Development and requires an advanced degree with 9+ years in late‑stage respiratory studies.

You will collaborate across Clinical Operations, Regulatory, Biostatistics, and Safety teams, manage study milestones, monitor