Senior Study Director, Rare Disease Translational

Maine Tech Hub; Bar Harbor (ME); Presencial; USD 99.000 - 166.000; Tempo integral

Resumo da vaga

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Scientific leadership

Project management

Strategic planning

Regulatory knowledge

Data analysis

Communication skills

Formação

Doctorate

Ferramentas

SAS

R

SPSS

Descrição da vaga

at The Jackson Laboratory in Bar Harbor, Maine, United States

Job Description

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

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 andChina. 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 visitwww.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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.