Associate Director/Director, Clinical Operations

Tris Pharma; 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

Paid Holidays, PTO

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking an Associate Director or Director, Clinical Operations to oversee planning, execution and daily operations of clinical studies while leading cross-functional teams to meet timelines, budget and quality standards.

The role requires hands-on experience in early-phase trials and oversight of CROs, with deep regulatory knowledge (GCP, CFR, ICH). The position offers hybrid work in NJ, substantial compensation and comprehensive benefits.

Qualifications

• Current, hands on experience working in early phase clinical studies/Phase I-III studies.
• Experience supervising or overseeing CROs and other clinical trial related vendors; including, but not limited to: identification, vetting and management throughout study lifecycle.
• Expertise and excellent understanding and application of global regulatory and compliance requirements for clinical research, including but not limited to: US CFR, EU EUCTD, and ICH GCPs.
• Current working knowledge of CFR Title 21 Part 314.80, Part 314.81, Part 314.98 and related FDA guidance.
• Demonstrated experience in project/program management and matrix leadership.
• Ability to influence without direct authority

Responsibilities

• Oversees operational delivery of one or more complex programs or studies, ensuring program/study deliverables and milestones are met with quality, timeliness and within budget.
• Serves as key operational point of contact for assigned programs/studies for portfolio leaders.
• Participates in program strategy meetings and contributes to the operational strategy for assigned programs/studies.
• Leads and collaborates with cross-functional teams to oversee performance of activities required to deliver programs/studies on time; Creates strong strategic partnerships with cross-functional colleagues ensuring consistent approaches to program/study delivery, data collection and reporting across programs.
• Provides direction and support to Clinical Operations team members and develops program/study operational strategies including, but not limited to: scenario models for optimal delivery linked to value drivers and implications for time, quality, risk and budget.
• Reviews and provides expert Clinical Operations input into clinical documents related to the drug development process including study synopsis and protocols, clinical study reports and all project plans.
• Provides regular executive updates to senior management; Oversees delivery quality, ensures inspection readiness and interacts regularly with program/study team members regarding issues, risks and successes related to study delivery.
• Supports study budget negotiations and manages Clinical Operations spending related to study execution; Works closely with Outsourcing Management, Finance and Clinical Operations Leadership to ensure budgets are accurate.
• Participates actively in external service provider selection, including CROs and other vendors, as necessary; Ensures appropriate CROs and vendors are identified, vetted and managed throughout the life of the study.
• Works with internal and external teams, as required ensuring programs are initiated and managed in line with company strategy and key clinical and regulatory milestones; Proactively identifies and communicates program/study issues that may impact budget, resources and timelines; escalates, as appropriate.
• Participates in vendor governance committees, as appropriate
• Leads and/or contributes to department initiatives and assists in the design and implementation of standardized work processes
• Provides expert and collegiate support to other members of the drug development team to ensure full success of company’s portfolio and regulatory milestones
• Assists in Standard Operating Procedures (SOPs) and working instruction development, review and approval
• Performs sponsor oversight of monitoring visits, including site qualification, study site initiation, routine monitoring and study site closure visits, including review of monitoring reports and follow-up letters
• Oversees and manages CRA teams and/or Clinical Trial Assistants, as applicable

Skills

Early phase clinical trials

CRO/vendor oversight

Regulatory knowledge (GCP, CFR, ICH)

FDA CFR familiarity

Project/program management

Influence without authority

Job description

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director or Director, Clinical Operations. Title and level commensurate with experience.

The Associate Director/Director, Clinical Operations is accountable for overseeing and directing the planning, execution and daily operations of an individual company study or portfolio of studies, as well as managing cross-functional teams to ensure delivery in accordance with established timelines, budget, and quality standards. The incumbent provides direction and guidance to Clinical Operations team members and develops program/study operational strategies including, but not limited to scenario models for optimal delivery linked to value drivers and implications for time, quality, risk and budget

• Oversees operational delivery of one or more complex programs or studies, ensuring program/study deliverables and milestones are met with quality, timeliness and within budget;
• Serves as key operational point of contact for assigned programs/studies for portfolio leaders;
• Participates in program strategy meetings and contributes to the operational strategy for assigned programs/studies
• Leads and collaborates with cross-functional teams to oversee performance of activities required to deliver programs/studies on time; Creates strong strategic partnerships with cross-functional colleagues ensuring consistent approaches to program/study delivery, data collection and reporting across programs
• Provides direction and support to Clinical Operations team members and develops program/study operational strategies including, but not limited to: scenario models for optimal delivery linked to value drivers and implications for time, quality, risk and budget
• Reviews and provides expert Clinical Operations input into clinical documents related to the drug development process including study synopsis and protocols, clinical study reports and all project plans
• Provides regular executive updates to senior management; Oversees delivery quality, ensures inspection readiness and interacts regularly with program/study team members regarding issues, risks and successes related to study delivery
• Supports study budget negotiations and manages Clinical Operations spending related to study execution; Works closely with Outsourcing Management, Finance and Clinical Operations Leadership to ensure budgets are accurate
• Participates actively in external service provider selection, including Contract Research Organizations (CROs) and other vendors, as necessary; Ensures appropriate CROs and vendors are identified, vetted and managed throughout the life of the study
• Works with internal and external teams, as required ensuring programs are initiated and managed in line with company strategy and key clinical and regulatory milestones; Proactively identifies and communicates program/study issues that may impact budget, resources and timelines; escalates, as appropriate
• Participates in vendor governance committees, as appropriate
• Leads and/or contributes to department initiatives and assists in the design and implementation of standardized work processes
• Provides expert and collegiate support to other members of the drug development team to ensure full success of company’s portfolio and regulatory milestones
• Assists in Standard Operating Procedures (SOPs) and working instruction development, review and approval
• Performs sponsor oversight of monitoring visits, including site qualification, study site initiation, routine monitoring and study site closure visits, including review of monitoring reports and follow-up letters
• Oversees and manages CRA teams and/or Clinical Trial Assistants, as applicable

Requirements

Qualifications:

• Current, hands on experience working in early phase clinical studies/Phase I-III studies
• Experience supervising or overseeing CROs and other clinical trial related vendors, as necessary; including, but not limited to: identification, vetting and management throughout study lifecycle
• Expertise and excellent understanding and application of global regulatory and compliance requirements for clinical research, including but not limited to: US Code of Federal Regulations (CFR), EU European Union Clinical Trials Directive (EUCTD), and International Counsil for Harmonization (ICH) Good Clinical Practices (GCPs)
• Current working knowledge of CFR Title 21 Part 314.80, Part 314.81, Part 314.98 and related FDA guidance
• Demonstrated experience in project/program management and matrix leadership
• Ability to influence without direct authority

Travel requirements:

15-25%

Work Arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office. Non-local candidates must be able to come into office multiple times a month.

Anticipated salary range:

Associate Director: $165 to $225K/yr

Director: $210 to $250K/yr

Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.