Senior Clinical Research Lead - Global Trials

NS Pharma, Inc.; Paramus (NJ); On-site; USD 175,000 - 205,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401(k) with company match

Discretionary Bonus Programs

Paid Time Off and holidays

Flexible work arrangements

Job summary

NS Pharma, Inc. is a research-driven biopharmaceutical company focused on rare diseases and a subsidiary of Nippon Shinyaku Co., Ltd. in Japan. The role oversees global clinical studies, CRO/vendor oversight, site activation, and recruitment strategies to align with FDA/ICH regulations and study plans.

The position requires leading international teams, coordinating documentation, budget and contract negotiations, and mentoring junior staff to ensure timely delivery of development milestones.

Qualifications

• Bachelor’s Degree in sciences or related field; 8+ years pharma/biotech experience.
• PMP certification preferred; 8+ years drug development experience.
• Experience managing international meetings and cross-functional teams.

Responsibilities

• Plan, implement, and report for regional or global clinical studies.
• Lead CRO/vendor selection and performance management.
• Coordinate with Clinical Lead to meet project objectives.
• Oversee patient recruitment strategies and enrollment data.
• Ensure SOPs, FDA/ICH compliance, and regulatory documentation.
• Coordinate with clinical suppliers and data management vendors.
• Mentor Sr. Managers and manage performance.
• Negotiate clinical trial contracts between sites and CROs.

Skills

Contract negotiations

Cross-functional leadership

Global collaboration

Regulatory compliance

Problem-solving

Project management

Multi-tasking

Communication skills

Education

Bachelor’s Degree in sciences or related field

PMP certification

Job description

NS Pharma, Inc. is a research-driven biopharmaceutical company focused on rare diseases and a subsidiary of Nippon Shinyaku Co., Ltd. in Japan. The role oversees global clinical studies, CRO/vendor oversight, site activation, and recruitment strategies to align with FDA/ICH regulations and study plans.

The position requires leading international teams, coordinating documentation, budget and contract negotiations, and mentoring junior staff to ensure timely delivery of development milestones.