Study Director, Rare Disease Translational Center

The Jackson Laboratory • Bar Harbor, ME

7d • Onsite

About The Position

The Jackson Laboratory (JAX) is seeking a Study Director for its Rare Disease Translational Center. This role involves developing and finalizing study protocols, leading and overseeing all aspects of assigned studies, and providing scientific guidance throughout the study lifecycle. The Study Director will ensure studies are conducted in accordance with regulatory requirements, implement quality control measures, and oversee data analysis and reporting. This position also involves leading and mentoring multidisciplinary project teams and identifying and mitigating potential risks. The ideal candidate will have extensive experience in scientific research, strong leadership and project management skills, and a thorough understanding of regulatory requirements in preclinical and clinical research.

Requirements

• Extensive experience in scientific research, preferably in a pharmaceutical, biotechnology, or contract research organization (CRO) environment, with a track record of successful study management.
• Proven leadership and project management skills, with the ability to effectively plan, organize, and coordinate complex research projects from initiation to completion.
• Proficiency in data analysis and interpretation, including 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.
• Strong leadership and interpersonal skills, with the ability to inspire and motivate multidisciplinary teams to achieve project objectives and deliver high-quality results.
• Strategic thinking and problem-solving abilities, with a proactive approach to identifying and resolving challenges that may arise during study execution.
• Thorough understanding of regulatory requirements governing preclinical and clinical research studies, including GLP, ICH guidelines, and other relevant regulations.
• Strong problem-solving skills with the ability to identify issues and implement effective solutions in a timely manner.
• Flexibility and adaptability to changing priorities and deadlines in a fast-paced, dynamic work environment.

Responsibilities

• Develop and finalize study protocols, including experimental design, methodology, and timelines, in collaboration with cross-functional teams and clients.
• Lead and oversee all aspects of assigned studies, including resource allocation, budget management, and timeline adherence, to ensure timely and efficient execution.
• Provide scientific guidance and expertise throughout the study lifecycle, including protocol development, data analysis, and interpretation of results.
• Ensure studies are conducted in accordance with relevant regulatory requirements.
• Implement quality control measures to maintain the integrity, accuracy, and reliability of study data, including oversight of documentation and record-keeping practices.
• Lead and mentor multidisciplinary project teams, including scientists, technicians, and support staff, to foster a collaborative and high-performing work environment.
• Oversee data analysis activities, ensure robust statistical analysis methodologies are applied, and prepare comprehensive study reports for internal review and client submission.
• Identify and mitigate potential risks and challenges that may impact study timelines, data quality, or compliance with regulatory requirements.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior