Sr. CLINICAL TRIAL MANAGER

ABOUT US:
Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Scripps Research is ranked one of the most influential institutions in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Calibr-Skaggs has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr-Skaggs' drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected diseases, as well as age-related and degenerative diseases. If you have a passion for making a difference, this could be your opportunity to join our transformative team.

POSITION TITLE: Sr. CLINICAL TRIAL MANAGER

POSITION SUMMARY:

The Senior Clinical Trial Manager supports the internal Calibr Clinical team and provides operational oversight to clinical stage programs and associated CRO/vendor partners in execution of early-phase clinical trials across multiple therapeutic areas. Focus on immuno-oncology and a wide range of programs covering neurodegeneration, metabolic disorders, autoimmunity, and others. Drives the development and execution of complex clinical programs, including design and planning of clinical studies, and delivers successful operational outcomes across multiple Phase 1 and 2 clinical trials. The Senior Clinical Trial Manager will apply their excellent operational capabilities as the main driver for project development and delivery within timelines and budget in accordance with Calibr Clinical Operation needs while ensuring compliance with ethical and regulatory requirements.

We have an exciting opportunity for a Senior Clinical Trial Manager at Calibr, a division of Scripps Research, is a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Scripps Research is ranked one of the most influential institutions in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading edge scientists.

RESPONSIBILITIES & DUTIES:

• Deliver operational excellence.
• Independent and proactive planning, day-to-day management, and oversight of assigned clinical projects, accountable for driving on-time delivery of milestones from initial clinical development through close-out.
• Development of tools for tracking and reporting of project deliverables to internal and external stakeholders.
• Develop and maintain active clinical trial documents including protocols, informed consent forms, case report forms, operational plans.
• Oversight of trial reporting responsibilities and documentation, including annual reports, final reconciliation and archival.
• Conduct data review and assist in identification of data discrepancies while engaging vendors, CROs and site personnel in resolution as needed.
• Monitor and/or co-monitor clinical trials sites, as necessary.
• Ensure inspection readiness including oversight of TMF maintenance and audit activities.
• Track investigational supplies, specimens, imaging.
• Lead vendor identification and selection and serve as primary management of vendor activities throughout study lifecycle.
• Adherence to the GCP/ICH Guidelines, SOPs, and other applicable guidelines.
• Lead contract and budget development, negotiation and reconciliation.
• Lead process improvement initiatives and departmental projects.
• Collaborate with department heads on development and maintenance of Standard Operating Procedures (SOPs).
• Provide support and mentorship of Clinical Operations colleagues.

POSITION REQUIREMENTS:

• Minimum BA/BS or equivalent or relevant and qualifying training and experience.
• 7+ years experience in clinical trial operations or management at a biotechnology or pharmaceutical company or CRO; or other relevant research or project management experience.
• Proven ability to independently manage entire clinical study lifecycle within budget and timeline while ensuring high quality deliverables and subject safety.
• Ability and willingness for travel (~10-25%).
• Excellent leadership, communication, and organizational skills.
• Able to take initiative and communicate cross-functional needs and expectations.
• Ability to proactively handle multiple projects, manage a diverse range of functional activities and solve problems.
• Strong communication and inter-personal skills.
• Highly responsive and proactive.
• Knowledge of CFR, GCP/ICH, EMEA and other relevant regulations and guidelines.
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams), Project Management software (MS Project, Smartsheet, etc) and other clinical trial systems (e.g., CTMS, EDC and eTMF).
• Strong problem resolution and conflict management skills.
• Attention to detail.
• Preferred: First-in-human/early-phase immuno-oncology clinical trial experience, including CAR T cell trial logistics and management.

PHYSICAL REQUIREMENTS:

May include: Stationary position for an extended period of time, traverse campus/facility as needed, operate machinery such as computer, phone, copy machine; exposure to cold or hot temperatures.

COMPENSATION:

The expected hiring range for this position is $158,700 to $175,000 commensurate with experience. Consideration will be given to experience that exceeds the listed requirements.

COMPREHENSIVE BENEFITS INCLUDE:

• Employer Contributed Retirement Plan - Depending on eligibility, employees receive an employer contributed retirement plan (no employee contribution required) and the option to contribute to a 403(b) (which is similar to a 401(k) using your own pre or post-tax dollars)
• Full Suite of Health and Welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and more
• Access to Flexible Spending Accounts (Medical/Dependent Care)
• Competitive vacation and sick leave policies
• Free, on-site parking

The above statements describe the level of work performed and expected in general terms. The statements are not intended to list all the responsibilities, duties and/or skills required of employees so classified, and the content herein is subject to change due to the business needs of Scripps Research, with or without notice. Furthermore, nothing in this job description shall be interpreted to be in conflict with or to eliminate or modify in any way the employment-at-will status of Scripps Research staff.

EEO Statement:
The Scripps Research Institute is an Equal Opportunity Employer. We promote diversity of thought, culture, and background in the fields of science. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic or status.