Senior Study Director, Rare Disease Translational Center
About The Position
The Senior Study Director leads and oversees scientific studies within a research or laboratory environment. The role provides strategic direction, scientific guidance, and leadership to multidisciplinary project teams to ensure successful execution of complex research projects, delivery of high-quality data, and achievement of project objectives in compliance with regulatory standards and client expectations. The Senior Study Director develops study strategies and oversees planning, execution, and reporting. They guide protocol development, data analysis, and interpretation; ensure compliance with GLP, ICH guidelines, and other applicable standards; implement quality controls and compliant documentation practices; mentor project teams; and prepare reports for internal review and client submission. The role also identifies and addresses risks affecting timelines, data quality, and compliance, and performs other duties as assigned.
Requirements
- At least 9 years of experience required; 12 years preferred.
- Doctorate required; doctorate preferred.
- Extensive scientific research, project management, and leadership experience in a pharmaceutical, biotechnology, or contract research organization environment, including a demonstrated record of leading complex research projects.
- Exceptional leadership and team-building skills.
- Ability to develop and execute strategic plans, prioritize tasks, and allocate resources effectively.
- Thorough understanding of regulations governing preclinical and clinical research, including GLP and ICH guidelines, and experience with regulatory interactions and submissions.
- Strong analytical skills and proficiency in data analysis and interpretation, including advanced statistical methods and software 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.
- Strategic problem-solving skills and a proactive approach to addressing challenges and continuous improvement.
- Meticulous attention to detail and commitment to data integrity, accuracy, and compliance.
- Flexibility and adaptability to changing priorities, deadlines, and client requirements, with the ability to perform in a fast-paced environment and under pressure.
- Advanced knowledge of genetic and molecular techniques relevant to rare disease research.
Responsibilities
- Develop strategic plans for scientific studies, including study design, methodology, and resource allocation, aligned with organizational goals.
- Lead and oversee study planning, execution, and reporting while meeting timelines, budgets, and regulatory requirements.
- Provide scientific guidance throughout the study lifecycle, including protocol development, data analysis, and interpretation of results.
- Ensure studies comply with GLP, ICH guidelines, and other applicable regulatory standards.
- Implement quality control measures and oversee documentation and record-keeping to maintain data integrity and regulatory compliance.
- Lead and mentor multidisciplinary project teams, fostering collaboration and professional development.
- Oversee data analysis, ensure appropriate statistical methodologies are applied, and prepare comprehensive study reports for internal review and client submission.
- Identify and mitigate risks and challenges that could affect timelines, data quality, or regulatory compliance.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
