The Judge Group · 4 hours ago
Associate Director Clinical Research & Development (1116738)
Troy Hills, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$140K/yr - $170K/yr
10+ years expThe Judge Group is seeking an Associate Director of Clinical Research & Development. This role involves assessing the viability of clinical ideas, designing and executing studies, and ensuring compliance with regulatory guidelines for clinical studies.
E-LearningInformation TechnologyProfessional Services
Responsibilities
Assess viability of 505(b)(2) and complex generics ideas from Clinical R&D perspective
Act as an independent clinical pharmacologist to identify required studies per the regulatory strategy, and to design and execute such studies
Responsible for providing clinical expertise pertaining to study design, planning and execution of Phase 1, Phase 2 or Phase 3 clinical studies
Ensures each project has a robust PK and clinical program and adheres to GCP, GLP and all applicable regulatory guidelines. Monitor changes/updates made to Guidance documents related to Clinical studies/BE studies and implementation thereof
Identify gaps in pre-clinical and Phase 1 DDP that could impact Phase 2/3 design and execution timelines for company internal projects as well as programs being evaluated as part of due diligence
Drafting of initial pediatric study plan (iPSP) and clinical sections of the regulatory submissions (eg. pIND, Type A/B/C/D meetings, NDA, etc.) for 505b (2) products
Partner with Regulatory Affairs for FDA meetings ensure successful execution of 505(b)(2) programs
Collaborate with R&D during product development to provide guidance on PK issues, developing biorelevant dissolution, PK modeling, simulations, WinNonlin, and IVIVC/IVIVR models
Collaborate extensively with Portfolio and Business Development and provide scientific feedback and clinical plans for identifying and developing new products through in-licensing or due diligence efforts
Works cross-functionally and with external partners to select clinical study designs to align with Company objectives; Works with Regulatory in filing of applications and responding to deficiencies
Qualification
Required
Ph.D. in a scientific discipline with at least 10 years of experience in the conduct of PK, clinical end point, and Phase 2/3 studies
Experience in generic/specialty pharmaceutical companies on a variety of dosage forms, including inhalation, topical, and complex injectable products is required
Clinical development experience with 505b (2) products is required
Thorough knowledge and understanding of scientific principles applicable to product development and extensive experience in PK modeling, simulation, IVIVC/IVIVR to support product development
Extensive knowledge of clinical development, including thorough understanding of the clinical development phases, processes and techniques used to execute a clinical development program
Knowledge of GCP, GLP, ICH and regulatory guidelines is essential
Preferred
Experience in CNS/Psychiatric therapeutics area (e.g., MDD, Schizophrenia, etc.) is preferred
Company
The Judge Group
Results through the Power of Experience.
1001-5000 employees
H1B Sponsorship
The Judge Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
unknown1997-02-14IPO
Leadership Team
Charlton Monsanto
Executive Vice President of Integrated Services and Innovation
Recent News
Seattle TechFlash
2025-09-12
2025-08-05
The Judge Group
2025-05-07
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