Respiratory Clinical Scientist Lead (Asthma/COPD) - Remote

Regulatory Jobs; Somerville (MA); Remoto; USD 186.000 - 270.000; Tempo integral

Resumo da vaga

Generate:Biomedicines is seeking a Director, Clinical Scientist to lead late-stage respiratory programs (asthma and COPD) and to serve as the clinical science lead on cross-functional teams, driving protocol development, data analysis, and regulatory submissions.

The ideal candidate has an advanced degree and 9+ years in clinical development, with proven ability to design trials, interpret data, and collaborate across Regulatory, Biostatistics, and Safety to advance therapies to patients.

Qualificações

• 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.

Responsabilidades

• Lead as clinical science lead and core member of clinical development teams for respiratory studies (asthma and/or COPD).
• Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements.
• Develop and author clinical protocols, CSRs, and regulatory documents in collaboration with leaders.
• Participate in medical monitoring activities to ensure data quality and participant safety.
• Collaborate with cross-functional teams to ensure trial execution and regulatory readiness.
• Contribute to governance meetings with study updates, data summaries, and risk assessments.

Conhecimentos

Clinical development leadership

Late-stage trial design

Cross-functional collaboration

Data analysis

Regulatory documentation

Formação

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

Descrição da vaga

Generate:Biomedicines is seeking a Director, Clinical Scientist to lead late-stage respiratory programs (asthma and COPD) and to serve as the clinical science lead on cross-functional teams, driving protocol development, data analysis, and regulatory submissions.

The ideal candidate has an advanced degree and 9+ years in clinical development, with proven ability to design trials, interpret data, and collaborate across Regulatory, Biostatistics, and Safety to advance therapies to patients.