Clinical Development Director - Oncology
New
Fully remote work model within the United StatesFull-TimeDirector
Salary274,788 - 371,773 USD per year
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Job Details
- Experience
- Minimum of 2 years of experience in clinical research and/or basic science research
- Required Skills
- GCP
Requirements
- MD or DO degree from an accredited medical school.
- Minimum of 2 years of experience in clinical research and/or basic science research.
- Strong background in genitourinary oncology, particularly prostate cancer.
- Prior experience within the biotechnology, pharmaceutical, or CRO industry.
- Deep understanding of clinical trial methodology, clinical development processes, biostatistics, and evidence generation.
- Knowledge of Good Clinical Practices (GCP), FDA regulations, EMA/CHMP guidelines, and international regulatory standards.
- Excellent communication and presentation skills.
- Demonstrated ability to work effectively within a matrixed global organization.
Responsibilities
- Lead and support clinical development activities for oncology programs focused on prostate cancer, including the execution of global scientific and medical evidence strategies.
- Collaborate cross-functionally with clinical, regulatory, safety, scientific affairs, and commercial teams to align development objectives and ensure successful program delivery.
- Provide clinical and scientific expertise throughout the design, execution, and interpretation of clinical trials, including participation in safety assessments and regulatory discussions.
- Contribute to the preparation of clinical study reports, publications, presentations, and regulatory submission documents.
- Build and maintain strong relationships with key opinion leaders, advisory boards, and external scientific communities to support innovation and research advancement.
- Identify new clinical research opportunities and support lifecycle management initiatives, strategic partnerships, and licensing activities when needed.
- Deliver scientific guidance for materials used in medical affairs and commercial activities while ensuring compliance with industry regulations and best practices.
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