Senior Study Director, Rare Disease Translational Center

The Jackson Laboratory

Bar Harbor (ME)

On-site

USD 99,000 - 166,000

Full time

3 days ago

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Job summary

The Jackson Laboratory in Bar Harbor, Maine seeks a Senior Study Director to lead complex preclinical studies, guide multidisciplinary teams, and ensure data integrity and regulatory compliance. You will shape study design, analysis, reporting, and risk management under GLP/ICH guidelines, delivering high-quality results for rare-disease projects.

Doctorate required with 9–12 years of experience; this full-time role emphasizes scientific leadership and strategic direction within a collaborative

Qualifications

Extensive experience in leading scientific projects within pharma/biotech/CRO environments.
Strong leadership, team-building and strategic planning abilities.
Thorough understanding of GLP and ICH regulations and regulatory interactions.

Responsibilities

Develop strategic plans for execution of scientific studies, including study design and resource allocation.
Lead and oversee all aspects of assigned studies, including planning, execution, and reporting.
Provide scientific guidance across study lifecycle, including protocol development and data interpretation.
Ensure compliance with GLP, ICH and related regulatory requirements.
Implement robust quality control and documentation practices for data integrity.
Mentor multidisciplinary teams to foster collaboration and professional growth.
Oversee data analysis activities and prepare study reports for internal and client review.
Identify and mitigate risks affecting timelines, data quality, or compliance.