Director, IT Strategy, Operations & Performance Management
Endo
Google Cloud PlatformPMP
Director, Clinical Scientist – Respiratory
Generate Biomedicines
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteSalary
💰 $186,000 - $279,000 per year
Job Level
Lead
Tech Stack
Google Cloud PlatformPMP
About the role
- Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD)
- Act as a key scientific contributor to late-stage protocols and regulatory submissions
- Design and develop clinical trial protocols and associated documents in collaboration with the clinical development leader
- Drive development of clinical study plans, data review plans, and clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)
- Interpret clinical data in collaboration with cross-functional colleagues and external partners
- Provide scientific input into case report forms (CRFs), database design, and statistical analysis plans
- Participate in data review and medical monitoring activities
- Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight
- Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
- Support development and execution of publication plans, abstracts, and manuscripts
- Contribute to TPPs, clinical development plans, and risk-benefit assessments
- Support medical monitor with management of oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)
- Leadership responsibilities including mentorship, cross-functional collaboration, and ensuring high standards of quality and rigor
Requirements
- Advanced degree (PhD, PharmD, MD, MS, PMP ) and 9+ years of industry experience in clinical development, including direct experience in late stage respiratory (asthma and/or COPD) 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
- PhD, PharmD, MD or equivalent required; respiratory scientific background preferred
- Nice to Have: Experience with both small molecule and biologic modalities
- Nice to Have: Familiarity with AI/ML-driven drug discovery platforms
- Nice to Have: Previous involvement in BLA or MAA submissions
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