Remote Study Director

Actalent; United States; Remote; USD 57,000 - 81,000; Full time

Job summary

Actalent is seeking a Study Director to supervise regulatory toxicology studies within a contract research organization. You will lead study design, execution, data interpretation, and reporting while ensuring GLP, EPA, FDA, DOT, OECD, ISO and other standards are met.

This role involves work with animal models to advance cancer research. You will supervise staff, coordinate studies, and serve as the primary liaison with sponsors in a fast-paced lab environment based in DAYTON, NJ.

Qualifications

• Hands-on toxicology and related assays experience in a regulated CRO/LA environment.
• Familiarity with EPA, FDA, DOT, OECD, GLP and ISO guidelines.
• Ability to supervise technical staff and coordinate multiple studies.

Responsibilities

• Supervise regulatory studies with day-to-day oversight of all phases.
• Design and implement study protocols ensuring regulatory compliance.
• Develop SOPs and experimental designs; supervise execution and data collection.
• Interpret and report study results to sponsors and stakeholders.
• Lead and mentor laboratory personnel; manage timelines and budgets.

Skills

Laboratory leadership

GLP regulatory knowledge

Scientific report writing

Communication with sponsors

Project coordination

Education

Bachelor of Science

Job description

Job Title: Study Director

Job Description

The Study director supervises and leads the conduct of regulatory studies within a contract research laboratory environment, focusing on toxicology and related scientific disciplines. This role combines hands-on scientific work with oversight of study design, implementation, data interpretation, and reporting, while ensuring strict adherence to GLP, EPA, FDA, DOT, OECD, ISO and other relevant regulatory standards. The Study director serves as a key technical expert, study director, and primary liaison with sponsors, contributing to studies that support the development of therapies, including work with animal models to help advance cancer research.

Responsibilities

• Supervise the conduct of regulatory studies, providing day-to-day direction and oversight of all phases of study execution.
• Assist in the development, design, and implementation of study protocols, ensuring scientific rigor and regulatory compliance.
• Establish test protocols and corresponding standard operating procedures (SOPs) for studies under your responsibility.
• Develop experimental designs and supervise the implementation of experiments and tests, including hands-on participation as needed.
• Obtain sponsor approval for study protocols and institute any necessary deviations from the test protocol with appropriate sponsor authorization.
• Ensure that all experimental data and observations, including unanticipated responses of the test system, are accurately recorded, verified, and documented.
• Ensure that tests are conducted in accordance with approved protocols, SOPs, GLP regulations, and relevant regulatory guidelines (EPA, FDA, DOT, OECD, ISO).
• Interpret, analyze, document, and report study results, preparing clear and comprehensive technical reports for sponsors and internal stakeholders.
• Act as a primary liaison with clients, maintaining professional communication, managing expectations, and responding to study-related inquiries.
• Oversee overall day-to-day laboratory operations related to assigned studies, including supervision and leadership of technical staff.
• Schedule and coordinate the initiation and conduct of studies, adapting to changing timelines and client-driven priorities in a fast-paced environment.
• Track study schedules and financial aspects of assigned studies on a regular basis, ensuring accurate monitoring of timelines and resources.
• Lead and mentor less experienced personnel, providing guidance on laboratory techniques, study procedures, and regulatory requirements.
• Run and oversee assays, including gene toxicity assays and other laboratory tests, ensuring high-quality, reliable results.
• Review weekly study schedules to determine required activities, ensuring all tasks align with protocol requirements and timelines.
• Check study protocols prior to execution to confirm procedures, dosing regimens, and data collection requirements.
• Conduct dosing studies in the vivarium, including measuring body weights of animals and administering test articles via single injection or other specified routes.
• Perform animal handling procedures, including wrapping and restraint as needed, while monitoring and documenting observations after dosing.
• Report study progress, summarize testing activities, and contribute to assay-related documentation and study reports.
• Support device-related testing activities as needed, including device preparation for testing, disassembly, extractions, and preparation of materials in accordance with ISO practices.
• Maintain good administrative practices, documentation accuracy, and compliance with all applicable quality and regulatory standards.

Essential Skills

• Bachelor of Science degree or equivalent experience in a relevant field such as toxicology, animal science, chemistry, biology, or microbiology.
• Hands-on working knowledge of the tests and assays under study responsibility, including cell culture, aseptic technique, and laboratory assays.
• Intimate working familiarity or the ability to quickly learn and develop familiarity with government regulations related to testing, particularly EPA, FDA, DOT, OECD, GLP regulations, and ISO standards.
• Demonstrated experience in GLP-regulated contract research organization (CRO) environments.
• Direct experience with mouse lymphoma assays.
• Direct experience with gene toxicity assays, including in vitro micronucleus (IVMN) assays.
• Experience working under OECD Guideline 490 for in vitro mammalian cell gene mutation tests.
• Strong administrative skills and leadership ability, including experience supervising technical staff in a laboratory setting.
• Ability to communicate effectively, both verbally and in writing, with sponsors, colleagues, and cross-functional teams.
• Proven ability to write clear, accurate, and detailed technical reports and documentation.
• Ability to manage multiple studies in a fast-paced environment with changing schedules driven by client needs.
• Comfort with animal handling and dosing procedures, including body weight measurements, single injections, and post-dose observations.

Additional Skills & Qualifications

• Experience in CRO environments similar to Eurofins, BioReliance, Toxikon, WuXi or comparable organizations.
• Background in biology, toxicology, or related laboratory sciences with experience in assay development and execution.
• Experience with PCR and other molecular biology techniques in a regulated laboratory setting.
• Familiarity with medical device testing, including device preparation, disassembly, extractions, and ISO-compliant testing practices.
• Experience leading and mentoring less experienced laboratory personnel, fostering a collaborative and learning-focused environment.
• Ability to work independently, take initiative, and proactively ask questions to clarify protocols and expectations.
• Strong organizational skills with the ability to handle detailed paperwork and documentation requirements.
• Comfort working in a fast-paced environment where study schedules and priorities can change based on client requirements.
• Experience in vivarium operations and in vivo toxicology studies.
• Interest in or prior exposure to animal-based research aimed at advancing cancer therapies.

Work Environment

This position is based in a contract research organization environment focused on animal studies and regulatory testing. The work is fast-paced, with schedules that can change frequently based on sponsor needs, requiring flexibility and strong time management. You will work primarily in laboratory and vivarium settings, performing assays, cell culture, gene toxicity testing, and in vivo dosing studies under GLP, OECD, EPA, FDA, DOT, and ISO frameworks. The environment is hands-on and task-focused, with opportunities to lead and mentor less experienced personnel while collaborating closely with technical staff and study sponsors. Work involves regular interaction with laboratory equipment, test systems, and animals, with a strong emphasis on documentation, protocol adherence, and regulatory compliance. The culture supports scientific rigor and the mission of working with animal models to help advance treatments, including those aimed at curing cancer.

Job Type & Location

This is a Contract position based out of DAYTON, NJ.

Pay and Benefits

The pay range for this position is $50.00 - $50.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of DAYTON, NJ.

Application Deadline

This position is anticipated to close on Nov 6, 2026.

Workplace Type

This is a fully onsite position in DAYTON,NJ.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.