Clinical Project Lead, Clinical Operations

Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.

As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.

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 a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.

CLINICAL PROJECT LEAD

SUMMARY

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 development and execution of protocols; achieving quality, timely completion, and on-target spending.

CORE RESPONSIBILITIES

• Ensures high quality execution of clinical trials that are in compliance with GCP, ICH and local regulatory requirements
• Oversees study vendors and contractors to ensure clinical trials are executed with high quality and within timelines and established budget parameters
• 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 Clinical Operations 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 Clinical Operations in regulatory inspection activities
• Reports project status, resource requirements and staff performance
• 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 project teams
• 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

QUALIFICATIONS

• Bachelor’s Degree preferred
• Minimum of eight (8) years of relevant Clinical Operations experience including at least five (5) 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

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS003099

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $171,852 to $237,534

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.