Director, Clinical Operations (Hybrid NJ)

BioSpace; South Brunswick (NJ); Hybrid; USD 165,000 - 250,000; Full time

Benefits offered by this job

Bonus eligible

Medical, dental, vision, Rx insurance

401K with match

Life insurance

Paid holidays

Job summary

Tris Pharma, Inc. is seeking an Associate Director or Director of Clinical Operations at our Monmouth Junction, NJ facility. This role oversees planning, execution and daily operations of one or more studies, guiding cross-functional teams to meet timelines, budget and quality standards.

The successful candidate will lead strategic operational initiatives, manage cross-functional study activities, and ensure compliance with regulatory requirements while optimizing value drivers and resource use.

Qualifications

• Bachelor's degree in a scientific or health care field; 7+ years clinical development/operation experience.
• Experience in early phase clinical studies (Phase I–III).
• Experience supervising or overseeing CROs and other trial vendors.
• Strong knowledge of global regulatory/compliance requirements (FDA CFR, EU EUCTD, ICH-GCP).
• Ability to influence without direct authority and lead cross-functional teams.

Responsibilities

• Oversee delivery of complex programs or studies within budget and timelines.
• Serve as operational lead and key contact for portfolio leaders; collaborate cross-functionally.
• Develop and implement program/study operational strategies and vendor governance.
• Provide input on study documents (synopsis, protocols, reports) and ensure inspection readiness.
• Manage study budgets with Outsourcing, Finance and leadership; monitor risks and issues.
• Lead or contribute to SOPs and standardized work processes.

Skills

Project/program management

Matrix leadership

CRO/vendor management

Influence without authority

Education

Bachelor's degree in science/healthcare

Job description

Tris Pharma, Inc. is seeking an Associate Director or Director of Clinical Operations at our Monmouth Junction, NJ facility. This role oversees planning, execution and daily operations of one or more studies, guiding cross-functional teams to meet timelines, budget and quality standards.

The successful candidate will lead strategic operational initiatives, manage cross-functional study activities, and ensure compliance with regulatory requirements while optimizing value drivers and resource use.