Senior Study Director (Rare Disease Translational Center)

Location: Bar Harbor, Maine, United States

Salary: $98,885–$165,554 annually; pay is determined by years of experience.

Company

hirify.global is an independent, nonprofit biomedical research institution focused on genetics, genomic solutions, and biomedical research.

What you will do

• Develop study strategies covering design, methodology, resources, timelines, budgets, and organizational objectives.
• Lead study planning, execution, reporting, protocol development, data analysis, and interpretation across the full study lifecycle.
• Provide scientific direction to multidisciplinary teams of scientists, technicians, and support staff while mentoring team members.
• Ensure compliance with GLP, ICH guidelines, and other applicable regulatory requirements, including regulatory interactions and submissions.
• Implement quality control, documentation, and data-integrity measures; identify and mitigate risks affecting timelines, data quality, or compliance.
• Oversee statistical analysis and prepare accurate, clear, scientifically rigorous reports for internal review and client submission.

Requirements

• At least 9 years of experience in scientific research, project management, and leadership roles within a pharmaceutical, biotechnology, or contract research organization environment; 12 years preferred.
• Doctorate required.
• Demonstrated success leading complex research projects and multidisciplinary teams.
• Strong strategic planning, prioritization, resource allocation, team-building, and problem-solving abilities.
• Thorough knowledge of preclinical and clinical research regulations, including GLP, ICH guidelines, regulatory interactions, and submissions.
• Advanced knowledge of genetic and molecular techniques relevant to rare disease research.
• Strong data analysis and interpretation skills, including advanced statistical methodologies and tools such as SAS, R, or SPSS.
• Excellent verbal and written communication skills for communicating complex scientific concepts to clients, internal stakeholders, and regulatory agencies.
• Meticulous attention to detail, commitment to data integrity and compliance, and adaptability to changing priorities, deadlines, and client requirements.

Culture & Benefits

• Work in an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center.
• Collaborate across a multidisciplinary research environment focused on improving human health.
• Equal employment opportunities are provided without regard to protected characteristics under applicable law.