Director Clinical Scientist
Director Clinical Research Scientist
Salary: $200,000 - $225,000
New York City (Hybrid)
Job Description
EPM is partnered with a cutting edge clinical stage biotech that is focused on transforming the way the immune system destroys cancer cells by developing a first of its kind allogenic approach for CAR-T immunotherapies. With mulitple muli-million dollar partnerships with big pharma to develop their assets, you have the chance to join the rare blend of a growing company with extensive financial backing.
Responsibilities
- Serve as the lead clinical scientist on the trial team, overseeing specific aspects of clinical and scientific execution for clinical protocols
- Guide the medical monitoring team in evaluating and interpreting clinical data and protocol deviations, collaborating with Clinical Research and Pharmacovigilance
- Partner 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
- Mentor other clinical scientists on tactical and scientific matters
- Assist in the creation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (authoring documents and preparing slides as needed)
- Apply analytical skills to understand program objectives and design impacts on data analysis; identify risks and develop mitigation strategies
- Promote consistent medical and clinical data review techniques across studies and programs
Qualifications
- 10+ years of experience with a Bachelor's degree, or 8+ 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)
- Experience within Hematology or Cell Therapy preferred
- 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
- Ability to influence opinions and decisions of internal and external stakeholders across functional areas
- Problem-solving, prioritization, conflict resolution, and critical thinking skills
- Strong communication, technical writing, and presentation skills
Benefits
- Medical
- Dental
- Vision
FAQs
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