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Study Director Jobs in Raritan, NJ (NOW HIRING)

Recursion

Director, Clinical Science

New York, NY · Remote

$212K - $261K/yr

As an Associate Director within Clinical Science, you'll play a critical role in ensuring study protocols are executed appropriately and that the study data is both appropriate and pristine. On a ...

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Study Director information

See Raritan, NJ salary details

$46.1K

$131.5K

$238.1K

How much do study director jobs pay per year?

As of Aug 8, 2026, the average yearly pay for study director in Raritan, NJ is $131,453.00, according to ZipRecruiter salary data. Most workers in this role earn between $59,400.00 and $193,000.00 per year, depending on experience, location, and employer.

What is the difference between Study Director vs Laboratory Manager?

AspectStudy DirectorLaboratory Manager
CredentialsTypically requires advanced degrees (e.g., MS, PhD) and relevant certificationsRequires relevant degrees and management experience, but not necessarily advanced research credentials
Work EnvironmentLeads specific research or regulatory studies, often in contract labs or pharmaceutical companiesOversees daily lab operations, staff, and compliance across multiple projects
Industry UsageCommonly used in GLP, clinical, and research settingsUsed broadly in laboratory settings across industries

The Study Director focuses on designing, overseeing, and ensuring the integrity of specific studies, often requiring scientific expertise. The Laboratory Manager handles overall lab operations, staff management, and compliance. Both roles are essential but differ in scope and responsibilities.

What is a study director?

A Study Director is the individual responsible for the overall conduct of a scientific study, particularly in regulated environments such as pharmaceuticals, chemicals, or environmental research. They oversee the planning, execution, and reporting of studies to ensure they comply with regulatory standards, such as Good Laboratory Practice (GLP). The Study Director acts as the main point of control and communication, coordinating among team members and ensuring that the study meets its scientific and regulatory objectives. Their role is critical for the integrity and quality of the data generated.

How does a study director typically collaborate with cross-functional teams during a research project?

As a Study Director, you play a central role in coordinating research activities by regularly collaborating with scientists, technicians, quality assurance personnel, and regulatory teams. You are responsible for ensuring all team members are aligned on study objectives, timelines, and compliance requirements. Effective communication and leadership are essential, as you facilitate meetings, delegate tasks, and resolve issues that arise to keep the project on track. This collaborative environment not only fosters professional growth but also provides valuable exposure to various scientific and operational domains within the organization.

What does a study director do?

As a study director, your job is to manage studies, analyze results, and interpret reports so you can deliver a summary of the findings. This work has three categories. First, on the technical side, your job includes creating the plan for the study, coordinating with other scientists, and overseeing data collection. In the administrative role, you monitor junior employees and ensure each investigation finishes within budgetary constraints. In the compliance role, you ensure that each study happens under strict safety and ethics protocols. You may be asked to run multiple studies at the same time, adding to the complexity of this position.

What skills and qualifications does a successful study director have?

To thrive as a Study Director, you need a solid background in scientific research methods, regulatory compliance, and study protocol development, usually supported by an advanced degree in life sciences or a related field. Familiarity with laboratory information management systems (LIMS), Good Laboratory Practice (GLP) standards, and project management tools is highly valued. Strong leadership, attention to detail, and effective communication are crucial soft skills for managing cross-functional teams and ensuring study integrity. These competencies are vital to ensure regulatory adherence, data accuracy, and successful project outcomes in research environments.
More about Study Director jobs
What cities near Raritan, NJ are hiring for Study Director jobs? Cities near Raritan, NJ with the most Study Director job openings:
Study Director jobs near you

Senior Director, Clinical Development

Mallinckrodt

Bridgewater, NJ • On-site

$81K - $111K/yr

Full-time

Re-posted 12 days ago

Mallinckrodt rating

8.0

Company rating: 8.0 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

43rd of 86 rated pharmaceutical

Job description

Job Title
Senior Director, Clinical Development
Requisition
JR000015848 Senior Director, Clinical Development (Open)
Location
Bridgewater, NJ
Additional Locations
Malvern, PA, Philadelphia, PA
Job Description Summary
Job Description
The Senior Director, Clinical Development (CD) is responsible for providing expert clinical advice across all phases (phase II-IV) of clinical research and will be the responsible clinical lead from the Clinical Development function. They will be responsible for oversight and management of the clinical development execution aspects of clinical development programs. Generally, the role will oversee multiple clinical study programs and/or therapeutic focus areas and establish a resource model to support those activities with both external and internal resources when / as indicated. This role has the ultimate oversight responsibility for leading CD activities including the design and development of clinical studies, writing in collaboration with Medical Writing, the required clinical documents such as, but not limited to, protocol concept form, clinical study synopsis, clinical study protocol, investigator brochures etc. They are ultimately accountable for the on-time achievement of study and/or program milestones in alignment with the program team strategic imperatives.
This position is also the clinical point of contact between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, regulatory authorities, medical affairs, Key Opinion Leaders, Advisory Boards, etc.
Key Accountabilities
Clinical Lead
  • Acts as the lead clinical representative on Project Teams.
  • Act as the key contributor in development of clinical development strategy across multiple indications.
  • Develop, review, guide and approve protocols, and amendments, ICFs, and clinical sections of other documents.
  • Oversee safety monitoring of ongoing clinical studies under their leadership with appropriate support as needed.
  • Interact and lead engagements with thought leaders within the respective therapeutic area/indication.
  • Track with Program Management the CD deliverables across all clinical studies/projects.
  • Lead identifying, contracting and engaging subject matter experts/thought leaders in advisory board meetings, consultancy etc.
  • Oversee regular maintenance and update of the CD project folders/drives.
  • Reviews the informed consent form (ICF); ensures alignment with the related safety sections of the study protocol.
  • Develops, reviews and/or approves clinical and safety and monitoring CRF pages.
  • Act as the key contributor in development of clinical development strategy across multiple indications.
  • Collaborates in study team meetings, data monitoring committee and steering committees as necessary.
  • Helps to identify additional opportunities within the broad R&D portfolio; propose indications and study design approaches for establishing proof of concept and help to identify and evaluate opportunities for in-licensing or mergers/acquisitions that would expand the platform portfolio.

Clinical Study Planning Development, Data and Reports
  • Review, guide and finalize study documents such as Protocol Synopses, Protocols, Protocol amendments, Administrative Change letters etc.
  • Ensure CD contributions to trial-related documents such as the IBs, ICF, CRFs, CRF Completion Guidelines, Study Execution and Monitoring Plans, Clinical Data Review Plan, Clinical Database specifications, statistical analysis plan, the data management plan, the safety management plan, the medical monitoring plan, Clinical Study Report (CSR) etc.
  • Ensure regular and ad-hoc data reviews and interpretation; preparation of summaries/documentations of these reviews to Leadership.
  • Ensure timely development of program-level documents, including, but not limited to, abstract and manuscripts, presentations, and various other internal and external documents and communications as needed.
  • Work collaboratively with the clinical study team and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (CSRs, IBs, IND sections, CTAs, ISS and ISE sections and clinical expert reports).

Clinical Operations
  • In collaboration with the Development Operations staff, develops the operational strategies for clinical research studies and development programs including, but not limited to, PI selection, CRO selection, budgets, and timelines.
  • Ensure CD participation in vendor selection, specification development, and management/oversight, as needed.
  • Ensure development of study specific training materials for study team, investigational sites, and vendors.
  • Participate and present at Investigator meetings or similar.
  • Lead the responses to scientific and data-related queries.
  • Collaborate with statistician in data review and interpretations.

Safety & Efficacy
  • Act as the primary medical monitor with support as required to identify any trial-related safety trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.
  • Develop and/or review narratives for AEs/SAEs/AESIs as necessary.
  • Collaborate with the statistician to identify any trial-related efficacy trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.

Qualifications
Education & Experience
  • Board licensed MD (or equivalent foreign qualification) in Immunology
  • Minimum of 8-10 years of Clinical Development experience (pharma, CRO) in Immunology/Autoimmunity
  • Previous experience designing and developing phase 1-4 protocols.
  • Therapeutic area experience preferred (demonstrable with 2 or more years relevant experience).
  • Demonstrates ability to analyze and interpret data, assess clinical relevance and present/report findings (e.g., ISS, ISE, competitor data, etc.).
  • Experience working on a matrix cross-functional clinical team.
  • Previous project management/clinical operations experience desirable.

Knowledge
  • Demonstrated ability to manage multiple and diverse projects concurrently.
  • Demonstrated ability to develop relationships and generate collaborations.
  • Strong analytical skills; a strategic thinker, planner and implementer; proven negotiating track record.
  • Solid Medical/Scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents.
  • Working knowledge of statistics, data analysis and data interpretation.
  • Experience with the operation aspects of clinical trials and related activities such as investigator meetings, DSMB's and GCP/ICH are necessary.
  • Excellent written and oral communication skills.
  • Organizational and cross functional collaboration skills.
  • Proficient in Microsoft Office Suite of Programs

Skills & Abilities
  • Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs, integrating clinical science, disease area knowledge, and operational requirements.
  • Incumbent must be able to work with colleagues at all levels of responsibility and authority.
  • Ability to work on multiple projects with aggressive timelines
  • Action oriented, flexible, able to adapt to changes in priorities, projects, and daily activities.
  • Strong presentation skills
  • Strong MSP skills

Physical Requirements
  • Up to 20% travel

Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova
The expected base pay range for this position is $285K - $315K. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.
This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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#LI-JP1
At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.
We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.
We are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.

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