Senior Study Director, Rare Disease Translational Science

Maine Tech Hub; Bar Harbor (ME); On-site; USD 99,000 - 166,000; Full time

Job summary

The Jackson Laboratory in Bar Harbor, Maine seeks a Senior Study Director to lead scientific studies within a regulated discovery and translational research setting. You will provide strategic direction, scientific oversight, and mentorship to multidisciplinary teams to ensure high-quality data and timely project delivery.

Responsibilities include study design, execution, analysis, reporting, GLP/ICH compliance, risk management, and collaboration with clients and internal stakeholders to advance

Qualifications

• Extensive experience leading complex research projects in pharma/biotech CRO settings.
• Strong leadership and cross-functional team management.
• Deep regulatory knowledge: GLP, ICH and related guidelines.

Responsibilities

• 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 across 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 GLP, ICH guidelines, and other regulatory standards.
• Mentor multidisciplinary project teams to foster collaboration and professional growth.
• Oversee data analysis activities, ensuring robust statistical methods and accurate study reports for internal and client review.
• Identify and mitigate risks affecting timelines, data quality, or regulatory compliance.

Skills

Scientific leadership

Project management

Strategic planning

Regulatory knowledge

Data analysis

Communication skills

Education

Doctorate

Tools

SAS

R

SPSS

Job description

The Jackson Laboratory in Bar Harbor, Maine seeks a Senior Study Director to lead scientific studies within a regulated discovery and translational research setting. You will provide strategic direction, scientific oversight, and mentorship to multidisciplinary teams to ensure high-quality data and timely project delivery.

Responsibilities include study design, execution, analysis, reporting, GLP/ICH compliance, risk management, and collaboration with clients and internal stakeholders to advance