Director, Clinical Scientist 2048178
Location: Remote
Focus: Rare Disease
Job Overview: The Clinical Scientist leads activities related to trial design, execution, and analysis of clinical trials. Represent, monitor clinical data, respond to regulatory queries, and SME on assigned protocols while addressing potential issues.
Primary Job Responsibilities:
- Lead the creation of clinical development plans, study synopses, and protocols, serving as the primary contact for clinical science inquiries.
- Monitor trial data for quality, manage tasks by external vendors, and maintain GCP compliance.
- Contribute to regulatory briefing packages, responses, and development for major regulatory submissions.
- Offer clinical and scientific input into regulatory documents, study reports, and ensure effective training and communication with study site staff.
- Represent clinical science in management teams and prepare presentation materials for various stakeholder meetings.
Primary Job Requirements:
- Advanced degree (PhD-/MD-/PharmD-level or equivalent relevant experience) with 5+ years in clinical drug development, preferably with experience in rare disease trials.
- Expert in therapeutic areas, staying current with scientific advances and using knowledge to push projects forward.
- Acts as a resource in scientific education for stakeholders and participates in external scientific discussions.
- Knowledgeable about clinical trial regulations, skilled in protocol and document development, and interacts with regulatory bodies.
- Experienced in managing vendor relationships, including overseeing CRO activities, and excels in complex project management.
- Strong communicator, adept in oral and written presentations, capable of independent work and driving team success.
- Demonstrates leadership, thrives in teamwork, offers creative problem-solving, and holds accountability for team goals.
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