Associate Director/Director, Clinical Operations

Tris Pharma•Monmouth Junction, NJ

1d•Hybrid

About The Position

Tris Pharma, Inc. is a leading privately-owned US biopharmaceutical company focused on the development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain, and addiction, addressing unmet patient needs. The company holds over 150 US and International patents and markets several branded ADHD products in the US, also licensing its products in US and ex-US markets. Their robust pipeline of innovative products employs proprietary science and technology spanning neuroscience and other therapeutic categories. 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 scenario models for optimal delivery linked to value drivers and implications for time, quality, risk, and budget.

Requirements

Bachelors degree in a scientific or health care field.
Minimum 7 years clinical development and/or operation experience, including majority of time in clinical study/project management in positions of increasing technical and leadership responsibility in the pharmaceutical, biotechnology, CRO, or related industry.
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 Council 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.

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 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.