Clinical Research Director
3 weeks ago
Director, Clinical Research Scientist - Job Summary
Proclinical Staffing is seeking a highly skilled Clinical Research Director to join our team at an established biotech. In this role, you will be instrumental in the strategic planning, design, and execution of clinical-stage programs.
Key Responsibilities:
- Support the clinical development of assigned programs and participate in the design and implementation of development strategies.
- Collaborate with clinical operations and cross-functional teams to execute clinical trial activities.
- Co-lead study team meetings with Clinical Operations study leads.
- Provide clinical/medical monitoring and associated documentation.
- Act as the primary point-of-contact for clinical science-related activities.
- Conduct ongoing medical/safety data reviews in collaboration with Clinical Sciences Physicians.
- Engage with internal and external partners, including key opinion leaders, clinical investigators, and health authorities.
- Develop and present Protocol and ICF documents/amendments.
- Independently resolve critical problems and ensure data collection aligns with protocols.
- Prepare clinical presentation slides and materials for various meetings and communications.
- Contribute to internal documents, regulatory submissions, and external publications.
- Participate in the development and enhancement of clinical development processes and tools.
- Engage in competitive intelligence and market assessment activities.
- Maintain scientific and clinical knowledge in oncology and related therapeutic areas.
Requirements:
- Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN, or similar).
- Experience in the pharma/biotech industry or relevant clinical/laboratory research.
- Experience with clinical trials and knowledge of Good Clinical Practice.
- Strong interpersonal, verbal, and written communication skills.
- Analytical and presentation skills.
- Ability to work independently and in a team setting.
- Comfortable in a fast-paced, entrepreneurial environment.
- Ability to travel up to 20%.
- In-office presence required 4 days per week.
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