Sr. Director, Clinical Operations
3 weeks ago
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Description
Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We have more than 150 US and International patents (including applications) and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another. We believe in each other and in respectful, open and honest communications to help support individual and team success.
We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.
The Senior Director, Clinical Operations provides expert strategic, scientific and operational leadership by leading strategic operational initiatives, building talent across the organization and by applying overall and specific project management and organizational leadership expertise to the clinical development portfolio. The incumbent is accountable for the Clinical Operations cross functional collaboration to develop program strategy and the implementation of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance.
Collaborating closely with Vice President/Clinical Development, manages and supports the clinical operations function by outlining scope of clinical trial programs and aligning resource needs, timelines, cost of services, etc.; Provides operational and scientific strategy, design and execution for multiple programs across various therapeutic areas
Accountable for communication of key performance indicators (KPIs) including, but not limited to: progress, status updates, mitigation strategy/plans, escalation of issues for trial or program level deliverables to senior management, etc.); Develops, implements, and/or manages adequate systems and procedures to ensure efficient day-to-day operations meeting company and affiliates' clinical trial needs
Leads clinical trial vendor and vendor personnel selection including, but not limited to: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, Medical Writers, etc. to meet clinical trial planning and execution obligations
Fosters a culture of quality-by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue resolution, risk mitigation and continuous improvement through strategic partnerships with Clinical Research Organizations (CROs) and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory guidelines, operating systems and procedures in clinical trials and maintains Clinical Operations training including vendor personnel and external contractors
Provides oversight and support to CRO Clinical Operations and Project Management areas ensuring ability to meet clinical, regulatory and business objectives through efficient completion of delegated tasks; Participates in identification and evaluation of potential investigators and other service vendors performing clinical study work
May also function as a Clinical Trial Manager(CTM), as needed
Requirements
Special knowledge or skills needed and/or licenses or certificates required
Bachelors degree in (para)medical, pharmaceutical or science related field and minimum 10 years Clinical Operations and/or Clinical Trial Management experience in a pharmaceutical, biotechnology, clinical research or related industry in positions of increasing technical and operational responsibility
Thorough knowledge of Good Clinical Practices (GCPs), International Conference on Harmonistaion (ICH) guidelines and regulatory requirements for clinical trial management
Current working knowledge of Code of Federal Regulations (CFR) Title 21 and related Food and Drug Administration (FDA) guidance
Demonstrated ability to build strong relationships with external partners, CROs and vendors with proven experience managing contract and clinical finance activities to work effectively with representatives from a broad range of scientific disciplines
Demonstrated ability to effectively procure, manage, and control project resources
Solid understanding of clinical indications and the drug development process
People management experience
Ability to influence without direct authority
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. #LI-hybrid
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