Senior Study Director, Rare Disease Translational Center

The Jackson Laboratory; Bar Harbor (ME); Sur place; USD 99 000 - 166 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Scientific leadership

Project management

Regulatory knowledge

Data analysis & statistics

Communication skills

Formation

Doctorate in a relevant field

Outils

SAS

R

SPSS

Description du poste

Job Summary Rare diseases affect millions of people, yet most have no approved treatments. The Rare Disease Translational Center (RDTC) at The Jackson Laboratory is working to change that by building clinically relevant mouse models and using them to test the therapies that could reach patients next, including emerging approaches such as gene therapy and RNA-based treatments. We’re looking for a motivated, detail-oriented full-time Senior Study Director to join our team in Bar Harbor, Maine. The Rare Disease Translational Center supports the overall mission of The Jackson Laboratory: To discover precise genomic solution for disease and empower the global biomedical community in the shared quest to improve human health. The RDTC works directly with foundations and their associated teams of basic and clinical researchers to generate custom mouse and cell based/in vitro models with clinical mutations to treat and cure rare diseases. This position is an exciting opportunity to work directly with the Center in supporting this mission. 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

Minimum Requirements Experience Required/Preferred: 9 years/ 12 years Education Required/Preferred: Doctorate/Doctorate Pay Range: $98,885 - $165,554, pay is determined by years of experience

About JAX:

The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center and nearly 3,000 employees in locations across the United States (Maine, Connecticut, California, New York, Florida), Japan and China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health. Founded in 1929, JAX applies over nine decades of expertise in genetics to increase understanding of human disease, advancing treatments and cures for cancer, neurological and immune disorders, diabetes, aging and heart disease. It models and interprets genomic complexity, integrates basic research with clinical application, educates current and future scientists, and provides critical data, tools and services to the global biomedical community. For more information, please visit www.jax.org.

EEO Statement:

The Jackson Laboratory provides equal employment opportunities to all employees and applicants for employment in all job classifications without regard to race, color, religion, age, mental disability, physical disability, medical condition, gender, sexual orientation, genetic information, ancestry, marital status, national origin, veteran status, and other classifications protected by applicable state and local non-discrimination laws.

Bar Harbor:

The Jackson Laboratory's 43-acre scenic Bar Harbor campus is nestled between the Gulf of Maine and the mountains of Acadia National Park. Some of the best hiking and biking in the world (over 50 square miles of mountains, lakes, views, and dramatic coastline) is accessible from our campus. We are one mile from downtown Bar Harbor, which offers a vibrant downtown district with a plethora of restaurants, shops, museums, and galleries.

Ellsworth:

The Charles E. Hewett Center in Ellsworth, Maine, is a state-of-the‑art facility that serves researchers world wide. The facility represents the culmination of nine decades of unmatched experience and leadership in breeding and caring for laboratory mice. Ellsworth, Maine, is one of Maine’s fastest growing cities. With a growth rate of nearly 20%, Ellsworth is a bustling year‑round community and acts as a hub for surrounding towns. It is located nearby Acadia National Park and hosts numerous special events, concerts and festivals each year. Residents have access to fabulous shopping, recreation, museums, galleries, and dining at a variety of independent restaurants.

Farmington:

JAX Genomic Medicine is transforming medicine by improving patient care, lowering costs, and increasing life span and health span. JAX Genomic Medicine’s research focuses on the complex genetic causes of disease and on the development of genomic solutions tailored to each person's unique genetic makeup. JAX Genomic Medicine sits on a 17-acre site on the campus of the University of Connecticut Health Center. The 183,500-square-foot facility opened in the fall of 2014. Now, it houses over 300 biomedical researchers, technicians, and support staff in state‑of‑the‑art computing facilities and laboratories. In Connecticut, JAX resides in the scenic town of Farmington, in the state’s capitol region. The Hartford region, which offers some of the best public schools in the country, is made up of both bigger cities and smaller, charming historic New England towns. JAX Genomic Medicine is also geographically located within 2 hours of Boston andNewYork and is close to multiple transportation systems, including bus lines, highways, railroads and international airports.

Sacramento:

The JAX® Mice, Clinical and Research Services facility is located in Sacramento, the state capital of California. Sacramento is less than a two-hour drive from San Francisco, Napa Valley, and scenic Lake Tahoe, and a short flight to both Los Angeles and Orange County. Sacramento is the birthplace of the nation’s Farm to Fork movement, and offers excellent restaurants, gastro‑pubs, wineries, theaters, and museums. Outdoor activities are plentiful: Boating, white water rafting, and riding the scenic bicycle trails are popular. Housing and other costs of living are more affordable in Sacramento and its surrounding suburbs than in most other neighboring areas in the North Bay, making Sacramento one of the hottest housing markets in the country year after year.

Augusta:

JAX’s Maine Cancer Genomics Initiative (MCGI) is located in Augusta, Maine, in the Harold Alfond Center for Cancer Care (HACCC), at Maine General Hospital. It began operations in 2016 with three overarching goals: to provide cancer genomic testing for Maine cancer patients; to develop and deliver physician education about clinical genomic cancer diagnostics; and to build a network in Maine of oncology practices conducting studies in genomic medicine.