Director Clinical Scientist
Director Clinical Scientist
Salary: $230,000 - $275,000
New York City (On Site)
Job Description
EPM is partnered with a clinical-stage biotech company that is creating innovative therapeis to treat patients with unmet medical needs in the Autoimmune, Fibrotic, and CNS space. With multi million dollar partnerships with peers in the industry, this opportunity offers an interesting blend of financial runway and room for growth. Their leadership has a proven track record of getting drugs to market and builiding high performance companies as well.
Responsibilities
- Serve as the lead clinical scientist on the trial team, overseeing specific aspects of clinical and scientific execution for clinical protocols
- Help in developing program strategy including clinical development plan and generate KOL relationships
- Work cross functionally with various departments to develop protocols and related study materials (e.g., informed consent forms, amendments), and coordinate with Clinical Operations on study deliverables
- Ensure case report forms (CRFs) are designed to align with protocol requirements, working closely with Clinical Data Management and Programming
- Collaborate across functions to monitor clinical data, ensuring the quality, completeness, and integrity of trial conduct
Qualifications
- 12+ years of experience with a Bachelor's degree, or 10+ years with a postgraduate degree
- Experience in clinical drug development, or a PhD, Pharm D, or RN degree is preferred
- Strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Ability to manage multiple priorities with effective planning, time management, and prioritization skills
- Strong analytical skills to interpret clinical trial data and draw conclusions
- Scientific expertise to propose, design, and execute clinical research and development studies, and author documents related to clinical trials (e.g., medical monitoring plans, statistical analysis plans, informed consent forms, clinical study reports)
- Ability to interact with key stakeholders across Clinical Development functional areas
- Proactive approach, strategic thinking, and leadership in driving clinical study goals
Benefits
- Medical
- Dental
- Vision
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