Director, Translational Medicine & Biomarker Strategy

NS Pharma, Inc.; Paramus (NJ); Hybrid; USD 175,000 - 220,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

Retirement Savings 401k with company 


Discretionary Bonus Programs

Flexibly scheduled work arrangement

Job summary

NS Pharma, Inc. is seeking a senior leader to manage translational and early-stage clinical studies across global programs. You will implement biomarker strategies, coordinate cross-functional teams including NS Pharma Japan HQ, and oversee trial execution from planning to data delivery.

You will lead CRO selection, site initiation, and investigator meetings, while ensuring FDA/ICH compliance and robust TMF/SOP processes. A hybrid role with Paramus office visits is expected.

Qualifications

• Experience working in multi-cultural global teams including NS Pharma Japan (HQ).
• Experience negotiating Master Service Agreements, project contracts and budgets.
• Strong leadership and ability to lead in a matrix organization while working independently.
• Thorough understanding of clinical operations from planning to closeout of studies.
• Ability to anticipate issues and define action plans; strong problem-solving skills.

Responsibilities

• Develop and deliver translational and early-stage clinical drug development strategy.
• Design and execute biomarker strategies to inform priorities and regulatory plans.
• Coordinate with discovery, clinical and CROs to meet biomarker and trial milestones.
• Plan, implement, and manage regional or global clinical studies and site initiation.
• Lead CRO selection and oversight; manage vendors and data management partners.
• Provide guidance with Clinical Lead to achieve project objectives and resolve issues.
• Coordinate training programs and develop TMF and SOPs within global QMS.
• Ensure regulatory compliance with FDA, ICH and SOPs across sites.

Education

PhD/MD with 8+ years in pharma/biotech R&D

MS/BS with 12+ years R&D leadership

Job description

NS Pharma, Inc. is seeking a senior leader to manage translational and early-stage clinical studies across global programs. You will implement biomarker strategies, coordinate cross-functional teams including NS Pharma Japan HQ, and oversee trial execution from planning to data delivery.

You will lead CRO selection, site initiation, and investigator meetings, while ensuring FDA/ICH compliance and robust TMF/SOP processes. A hybrid role with Paramus office visits is expected.