Associate Director, Global Clinical Research & Trials

NS Pharma; Paramus (NJ); On-site; USD 190,000 - 205,000; Full time

Benefits offered by this job

Discretionary Bonus Programs

Long-term Incentive Plan

401k with company match

Generous Paid Time Off

Flexible Work Arrangement Programs

Career Development

Job summary

NS Pharma is a biopharmaceutical company focused on rare diseases, seeking an Associate Director of Clinical Research to lead global studies in compliance with FDA, ICH, and regulatory standards. The role oversees CROs, vendors, patient recruitment, and TMF creation, ensuring timely delivery in line with development plans.

The position requires 8+ years in drug development, a Bachelor’s in sciences, and PMP preferred.

Qualifications

• Experience negotiating Master Service Agreements, Project Specific Contracts and Budgets.
• Strong cross-functional leadership and teamwork in a global, multicultural environment.
• Understanding of clinical operations from planning through closing of clinical studies, with regulatory knowledge.

Responsibilities

• Plan, implement, manage and report for regional or global clinical studies.
• Lead selection process of CROs for regional or global studies.
• Oversee performance of study vendors (CROs and central labs).
• Coordinate with Clinical Lead to achieve project objectives.
• Manage and resolve project performance issues as they arise.
• Coordinate site selection and activation, investigator meetings and study initiation.
• Provide guidance to Sr. Managers in Clinical Research.
• Develop recruitment strategies and oversee patient recruitment.
• Create study documentation (protocol, ICF, CRF, SOPs, TMF).
• Track data, regulatory documents, and enrollment to meet development plans.
• Ensure site compliance with SOPs and FDA/ICH requirements.
• Coordinate contracts between sites and CROs.
• Coordinate data management and statistical analysis vendors.
• Ensure timely delivery of trial supplies to sites.
• Develop training material and SOPs; maintain TMF.

Skills

Contract negotiations

Cross-functional leadership

Global team collaboration

Drug development

Project management

Communication

Team leadership

Education

Bachelor’s Degree in sciences or related field

PMP certification preferred

8+ years drug development experience

Job description

NS Pharma is a biopharmaceutical company focused on rare diseases, seeking an Associate Director of Clinical Research to lead global studies in compliance with FDA, ICH, and regulatory standards. The role oversees CROs, vendors, patient recruitment, and TMF creation, ensuring timely delivery in line with development plans.

The position requires 8+ years in drug development, a Bachelor’s in sciences, and PMP preferred.