Jobs · Analyst

Director, Clinical Scientist (Respiratory indications)

Generate:Biomedicines · United States · 5 days ago
RemoteRemoteAnalyst$186k–$270k/yrFull-time

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

Act as a key scientific contributor to late-stage protocols and regulatory submissions; Design and develop clinical trial protocols and associated documents (e.g. clinical study plans, data review plans, case report forms (CRFs), database design, tatistical analysis plans) in collaboration with the clinical development leader

Drive development of clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)

Participate in medical monitoring activities: review and interpret clinical data on an ongoing basis in collaboration with cross-functional colleagues and external partners to ensure data quality, participant safety, and protocol compliance. Escalate issues as appropriate.

Participate in site selection, initiation, and ongoing engagement; provide scientific support to investigators and address protocol-related inquiries

Contribute to internal governance meetings (presenting or preparing study updates, data summaries, and key risks/issues)

Ensure inspection readiness (maintain high-quality documentation and support audit/inspection activities).

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:

  • Take ownership of clinical execution and ensure accountability to high standards of quality and rigor
  • Collaborate across functions with transparency and technical precision
  • Foster an inclusive and high-performing team culture, offering mentorship and coaching where appropriate
  • Communicate clearly and consistently, using data to inform decisions and recommendations
  • Adapt readily to change and demonstrate resilience and curiosity in the face of ambiguity

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