Associate Director/Director, Clinical Operations

Tris Pharma Inc•South Brunswick, NJ

2d•$165,000 - $250,000•Hybrid

About The Position

Tris Pharma, Inc. is a privately-owned US biopharmaceutical company focused on developing and commercializing innovative medicines for conditions such as ADHD, spectrum disorders, anxiety, pain, and addiction. The company holds over 150 US and International patents and markets several branded ADHD products in the US, while also licensing its products domestically and internationally. Tris Pharma has a robust pipeline of innovative products utilizing proprietary science and technology, spanning neuroscience and other therapeutic categories. The company values its team members, recognizing them as the driving force behind its passion and innovation. Colleagues are expected to understand the criticality of operating a successful business and take pride in the company's success, fostering an environment of respectful, open, and honest communication to support individual and team success. An immediate opening exists in the Monmouth Junction, NJ facility for an Associate Director or Director, Clinical Operations. The title and level will be commensurate with experience. The Associate Director/Director, Clinical Operations is responsible for overseeing and directing the planning, execution, and daily operations of individual company studies or a portfolio of studies. This role involves managing cross-functional teams to ensure delivery in accordance with established timelines, budget, and quality standards. The incumbent will provide direction and guidance to Clinical Operations team members and develop 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 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

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 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; escalate, 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