Clinical Project Lead
Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
CLINICAL PROJECT LEAD
The Clinical Project Lead (CPL) is responsible for providing Clinical Operations leadership to one or more clinical projects. As the Clinical Operations subject matter expert, the CPL collaborates with other functional areas to ensure successful execution of protocols; achieving quality, timely completion, and on-target spending.
- Oversees study vendors and contractors to ensure clinical trials are executed with high quality and within timelines and established budget parameters
- Achieves high quality execution of clinical trials that are in compliance with GCP and regulatory requirements
- Leads project specific meetings with executive management team
- Identifies operational issues across protocols and ensures resolution
- Implements best industry practice standards across assigned studies
- Provides strategic and tactical guidance in risk management of clinical trial execution; develops and executes risk mitigation plans
- Provides guidance on the development and implementation of clinical protocols
- Engages in corporate partnership alliance relationship management, as necessary
- Negotiates vendor contract terms and ensures proper execution
- Leads vendor selection activities; establishes vendor oversight expectations and ensures proper execution of the vendor management plans; establishes and monitors Key Performance Indicators
- May perform the Clinical Trial Manager (CTM) function on one or more trials
- Participates in process improvement initiatives to increase quality, productivity, and efficiency of the Clinical Trial Management functions
- Participates in Quality Assurance efforts
- Represents/leads Clinical Operations in regulatory inspection activities
- Regularly reports project status, resource requirements and staff performance to the Head of Clinical Operations
- Participates in the development and management of project budgets; proactively manages study budgets, including accurate forecasting and cost accruals
- Maintains optimal relationships with key internal partners and stakeholders to enable successful execution of trials
- Anticipates project needs and implements solutions
- Maintains clinical trial management expertise through clinical trial literature review, ongoing awareness of industry practices and participation in professional activities
- Utilizes appropriate IT systems and ensures that clinical trial team utilizes and updates systems and tools to enable successful trial execution
- May serve as direct line manager for one or more Clinical Operations team members; conducts annual performance evaluations
- Travel is variable and estimated at 20%
COMPETENCIES IDENTIFIED FOR SUCCESS:
- Proven track record with leading teams on high priority projects
- Ability to influence others and resolve dynamic tensions
- Demonstrated self-starter with a high level of commitment
- Proven track record for making sound decisions
- Solid analytical and proactive problem-solving skills
- Ability to think globally and strategically, while maintain adequate knowledge of clinical trial details
- A team player with strong interpersonal skills
- Effective written and verbal communication skills
- Outstanding organizational skills with the ability to multi-task and prioritize
- Flexible to an ever-changing environment
- Ability to identify and execute staff development strategies
- Bachelor’s Degree preferred
- Minimum of eight (8) years of relevant Clinical Operations experience including at least three (3) years of experience in clinical trial management
- Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process, Data Management Overview
- Working knowledge of ex-US regulatory requirements
- Demonstrated knowledge in several relevant therapeutic areas; experience in rare disease indications a plus
- Proficiency in MS Office including Word, Excel, and PowerPoint; Project and Visio a plus
Excellent salary and benefits package offered.
Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition # 18-0172
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.