Medical Director, Clinical Development
Organon
June 25, 2026
Remote
United States
Clinical Research and Development
The Medical Director works closely with the Executive Director and Clinical Development, providing protocol design and scientific oversight for clinical research studies of new or marketed drugs. The role contributes to clinical development and regulatory strategy for assigned assets, and is accountable for the design, execution, oversight, monitoring, and reporting of clinical trials.
Responsibilities
- Lead or contribute to development and updates of the global clinical development plan.
- Identify/vet clinical trial sites; design patient-centered clinical protocols that support strategic objectives and recruitment timelines.
- Represent clinical development on study teams; resolve execution barriers with clinical operations and partners.
- Provide clinical input to key documents (informed consent, data review plan, medical monitoring plan, statistical analysis plan, clinical review forms, case report forms, data edit checks).
- Participate in designing and conducting Investigator Meetings.
- Monitor study conduct to ensure efficient recruitment, data quality, protocol fidelity, and minimize compliance/quality risks.
- With biostats and safety, interpret efficacy/safety data and author CSR.
- Directly monitor/provide oversight to CRO medical monitors; monitor safety and contribute to safety narratives/reports.
- Partner with regulatory affairs on clinical development/regulatory strategy; author/edit regulatory documents (briefing packages, response documents, submission dossiers).
- Coauthor abstracts/publications; review IIS proposals as requested; support advisory boards, patient advocacy engagement, and life-cycle management opportunities; participate in due diligence.
Requirements
- MD, DO, or MRCP.
- 2–4 years clinical development experience in biotech/pharma.
- Preferred: women’s health, dermatology, or pediatric development experience; academic leadership/research experience considered.
- Familiarity with ICH, GCP, and clinical trial execution/medical monitoring.
- Up-to-date with regulatory guidance and literature; strong data interpretation/quality analysis.
- High independence, integrity, strong written/oral communication; fluent English.
- Travel may be required.
Preferred/Other
- Remote within the US.
Responsibilities
- Lead or contribute to development and updates of the global clinical development plan.
- Identify/vet clinical trial sites; design patient-centered clinical protocols that support strategic objectives and recruitment timelines.
- Represent clinical development on study teams; resolve execution barriers with clinical operations and partners.
- Provide clinical input to key documents (informed consent, data review plan, medical monitoring plan, statistical analysis plan, clinical review forms, case report forms, data edit checks).
- Participate in designing and conducting Investigator Meetings.
- Monitor study conduct to ensure efficient recruitment, data quality, protocol fidelity, and minimize compliance/quality risks.
- With biostats and safety, interpret efficacy/safety data and author CSR.
- Directly monitor/provide oversight to CRO medical monitors; monitor safety and contribute to safety narratives/reports.
- Partner with regulatory affairs on clinical development/regulatory strategy; author/edit regulatory documents (briefing packages, response documents, submission dossiers).
- Coauthor abstracts/publications; review IIS proposals as requested; support advisory boards, patient advocacy engagement, and life-cycle management opportunities; participate in due diligence.
Requirements
- MD, DO, or MRCP.
- 2–4 years clinical development experience in biotech/pharma.
- Preferred: women’s health, dermatology, or pediatric development experience; academic leadership/research experience considered.
- Familiarity with ICH, GCP, and clinical trial execution/medical monitoring.
- Up-to-date with regulatory guidance and literature; strong data interpretation/quality analysis.
- High independence, integrity, strong written/oral communication; fluent English.
- Travel may be required.
Preferred/Other
- Remote within the US.