As a Senior Study Director, you will play a critical role in leading and overseeing scientific studies within a research or laboratory environment. Building upon your extensive experience and expertise, you will be responsible for providing strategic direction, scientific guidance, and leadership to multidisciplinary project teams. Your primary objective will be to ensure the successful execution of complex research projects, driving the delivery of high-quality data and achieving project objectives in compliance with regulatory standards and client expectations.

Key Responsibilities & Essential Functions

• Develop strategic plans for the execution of scientific studies, including study design, methodology, and resource allocation, in alignment with organizational goals and objectives.
• Lead and oversee all aspects of assigned studies, including study planning, execution, and reporting, ensuring adherence to timelines, budgets, and regulatory requirements.
• Provide scientific guidance and expertise throughout the study lifecycle, including protocol development, data analysis, and interpretation of results, to drive decision-making and project success.
• Ensure studies are conducted in accordance with relevant regulatory requirements, such as Good Laboratory Practice (GLP), International Conference on Harmonisation (ICH) guidelines, and other applicable standards.
• Implement robust quality control measures to maintain the integrity, accuracy, and reliability of study data, overseeing documentation and record-keeping practices to ensure compliance with regulatory standards.
• Lead and mentor multidisciplinary project teams, including scientists, technicians, and support staff, to foster a collaborative and high-performing work environment, promoting professional growth and development.
• Oversee data analysis activities, ensuring robust statistical analysis methodologies are applied, and prepare comprehensive study reports for internal review and client submission, with a focus on accuracy, clarity, and scientific rigor.
• Identify and mitigate potential risks and challenges that may impact study timelines, data quality, or regulatory compliance, implementing proactive measures to address issues and drive project success.
• Other duties as assigned.

Knowledge, Skills, and Abilities

• Extensive experience in scientific research, project management, and leadership roles within a pharmaceutical, biotechnology, or contract research organization (CRO) environment, with a demonstrated track record of success in leading complex research projects.
• Exceptional leadership and team-building skills, with the ability to inspire and motivate multidisciplinary teams to achieve project objectives and deliver high-quality results.
• Strategic mindset with the ability to develop and execute strategic plans, prioritize tasks, and allocate resources effectively to achieve organizational goals and objectives.
•  Thorough understanding of regulatory requirements governing preclinical and clinical research studies, including GLP, ICH guidelines, and other relevant regulations, with experience in regulatory interactions and submissions.
•  Strong analytical skills with proficiency in data analysis and interpretation, including advanced statistical analysis methodologies and software tools (e.g., SAS, R, SPSS).
•  Excellent verbal and written communication skills, with the ability to convey complex scientific concepts clearly and effectively to diverse audiences, including clients, internal stakeholders, and regulatory agencies.
• Strategic problem-solving abilities, with a proactive approach to identifying and addressing challenges, implementing effective solutions, and driving continuous improvement initiatives.
• Meticulous attention to detail and a commitment to maintaining the highest standards of data integrity, accuracy, and compliance in all aspects of study conduct and reporting.
• Flexibility and adaptability to changing priorities, deadlines, and client requirements in a dynamic and fast-paced work environment, with the ability to thrive under pressure and deliver results

*Advanced knowledge of genetic and molecular techniques relevant to rare disease research

Experience Required/Preferred: 9 years/ 12 years

Education Required/Preferred: Doctorate/Doctorate

Pay Range: $98885 - $165554