What are the responsibilities and job description for the Clinical Science Director (Remote) position at Meet?
Summary:
Our client is seeking a Clinical Science Director to collaborate with clinical and project teams to design, plan, and develop oncology clinical studies. This role involves authoring clinical development documents, summarizing study results, supporting project teams with scientific insights, and providing progress updates on clinical studies.
Essential Duties and Responsibilities:
- Design, prepare, and initiate study protocols and related documentation in compliance with project plans, federal regulations, GCP, and good medical practices.
- Interact with investigators and thought leaders to facilitate clinical protocol design.
- Conduct literature research and assist in investigator selection for clinical studies.
- Collaborate on the development of informed consent forms, case report forms (CRFs), and CRF instructions.
- Serve as a contact for medical monitor inquiries with oversight from the program's Medical Monitor.
- Develop agendas, training materials, and presentations for investigator meetings and site visits.
- Participate in safety meetings, analyze safety events, and support regulatory filings and study close-out reports.
- Contribute to writing and reviewing abstracts, publications, and presentations for scientific meetings.
- Maintain clinical and technical expertise in oncology and provide clinical education support internally.
Qualifications:
- Education: Pharm.D., Ph.D., or M.D. with 8 years of related experience, or an equivalent combination of education and experience.
- Experience: 5-8 years in clinical development within the biotech or pharmaceutical industry, including oncology studies with molecular targeted or immunological therapies.
Knowledge/Skills:
- Strong understanding of clinical trial implementation and oncology drug development.
- Proficiency in designing, executing, and reporting clinical trials.
- Excellent analytical, organizational, and business communication skills.
- Ability to manage multiple priorities under tight timelines.
- Strong public speaking and presentation abilities.
Travel:
10-25% travel required.
This role involves solving complex problems with innovative approaches and requires collaboration across internal and external stakeholders.
Salary : $101 - $112
