Study Director - Group Leader
- Full-time
- Compensation: USD 90000 - USD 113000 - yearly
Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
2025, Eurofins generated total revenues of EUR € 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
The Group Leader - Study Director is responsible for the scientific, regulatory, operational, and personnel leadership of a team conducting GLP-compliant studies. This role serves as both a Study Director and people leader, overseeing the design, conduct, interpretation, and reporting of complex studies while managing a team of Study Directors, scientists, and technical staff.
The successful candidate will ensure studies are conducted according to applicable GLP regulations, client requirements, and company quality standards while driving operational efficiency, staff development, and business growth. This individual acts as a key client contact and collaborates with internal stakeholders to deliver high-quality scientific outcomes and exceptional customer service.
Essential Responsibilities
Leadership & Management Responsibilities
- Provide direct leadership, coaching, mentoring, and performance management for Study Directors, scientists, and technical staff.
- Manage day-to-day laboratory and study operations, ensuring efficient utilization of personnel and resources.
- Oversee staffing, workload planning, scheduling, and prioritization of studies across the group.
- Recruit, develop, train, and retain scientific staff while fostering a culture of scientific excellence, quality, and continuous improvement.
- Conduct performance evaluations, establish development plans, and support employee career growth.
- Collaborate with senior leadership to establish departmental objectives, resource planning, and business strategies.
- Ensure study timelines, deliverables, budgets, and financial performance metrics are monitored and achieved.
- Identify opportunities to improve operational processes, productivity, quality, and client satisfaction.
- Ensure compliance with company policies, GLP regulations, and applicable regulatory guidelines.
Study Director Responsibilities
- Serve as Study Director for assigned studies and maintain responsibilities as defined by GLP regulations.
- Supervise and oversee all phases of study conduct from initiation through final reporting.
- Assist with protocol development, study design, implementation, and execution.
- Provide scientific guidance and technical leadership throughout study activities.
- Interpret study data and prepare scientifically accurate reports and conclusions.
- Act as the primary scientific and operational liaison with clients.
- Ensure studies are conducted according to approved protocols, SOPs, and applicable regulatory requirements.
- Communicate study progress, results, deviations, and timelines to sponsors and internal stakeholders.
Technical Responsibilities
- Maintain overall responsibility for the technical conduct, interpretation, analysis, documentation, and reporting of assigned studies.
- Establish study protocols, procedures, and supporting SOPs.
- Develop experimental designs and provide oversight for execution of studies.
- Obtain sponsor approval of study protocols and manage protocol amendments and deviations as required.
- Ensure experimental data and observations are accurately collected, documented, reviewed, and verified.
- Monitor study activities to ensure compliance with approved protocols, SOPs, GLP regulations, and regulatory guidance.
- Review and approve data analyses, study reports, and scientific conclusions.
- Ensure quality, integrity, and regulatory acceptability of study data and documentation.
- Provide technical training and scientific mentorship to Study Directors, scientists, and laboratory personnel.
- Maintain effective communications with sponsors regarding study progress, technical issues, and project outcomes.
- Support interactions with regulatory agencies related to study conduct, protocol development, GLP compliance, and submitted studies.
- Participate in audits, inspections, and regulatory reviews as required.
- Ability to safely wear respiratory protection when required.
Qualifications
- B.S, M.S., or related advanced degree in Toxicology, Pharmacology, Biology, Chemistry, Veterinary Science, Life Sciences, or a closely related scientific discipline.
- Minimum 5 years of experience overseeing biocompatibility studies as a Study Director or equivalent scientific leadership role.
- Demonstrated experience managing multiple concurrent studies, timelines, budgets, and client relationships.
- Strong working knowledge of GLP regulations, regulatory guidelines, and quality systems.
- Proven experience authoring protocols, study reports, and regulatory documentation.
- Excellent scientific writing, organizational, communication, and leadership skills.
- Ability to effectively interact with clients, regulatory authorities, and cross-functional teams.
Preferred Qualifications
- 8+ years of Study Director experience within a CRO, pharmaceutical, biotechnology, chemical, or life sciences environment.
- Experience leading teams of Study Directors or scientific managers.
- Experience supporting FDA, EPA, OECD, or other regulatory submissions.
- Demonstrated success managing business operations, study profitability, and resource planning.
- Experience contributing to business development, client growth, and strategic initiatives.
Additional Information
Position is full-time, Monday-Friday, 9:00am.- 5:00 pm, with overtime as needed. Candidates currently living within a commutable distance of Dayton, NJ are encouraged to apply.
Excellent full time benefits including:
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
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