Medical Monitor

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

MEDICAL MONITOR (MM)

The role of the Medical Monitor (MM) is to provide oversight of the safety and efficacy in clinical trials. They act as the main point of contact for investigators, or provide Ionis input to an outsourced Medical Monitor, for a project team. The MM also helps provide their medical expertise to define the clinical strategy and protocol development.

Key Responsibilites

Safety Oversight

• Monitor and evaluate adverse events (AEs) and serious adverse events (SAEs).
• Make decisions on dose modifications, treatment discontinuation, or unblinding in response to safety concerns
• Ensure participant safety through continuous data review and risk-benefit analysis
  
  

Protocol Development & Review

• Provide input on study design, eligibility criteria, safety monitoring criteria and frequency of safety assessments, efficacy and schedule of activities (SoA).
• Align protocols with standard of care and regulatory guidelines (e.g., ICH-GCP, FDA, EMA)
  
  

Data Review & Interpretation

• Critically review efficacy and safety clinical trial data
• Support CSR review activities including SAE narratives
• Medical related protocol deviations
  
  

Regulatory & Ethical Compliance

• Ensure adherence to Good Clinical Practice (GCP), SOPs, and applicable regulations.
• Participate in Data Safety Monitoring Boards (DSMBs) and regulatory submissions
  
  

Stakeholder Communication

• Act as a liaison between Ionis, investigators, CRO and trial sites.
• Address protocol-related queries and provide medical guidance to site staff
  
  

Training & Collaboration

• Support training initiatives for internal teams, investigators and site staff on protocol requirements and procedures
• Work with cross-functional teams including CRAs, project managers, and medical writers
  
  

Qualifications

Education

• MD or equivalent medical degree.
• Specialization in therapeutic areas (e.g., neurology, cardiology) is a plus Typically requires a minimum of 15 years of related experience with a bachelor’s degree; or 12 years with a master’s degree; or 8 years with a PhD; or equivalent experience.
  
  

Experience

• At least 3 years in clinical research or drug development.
• Prior roles in pharmacovigilance, CRA, or clinical study management are beneficial
  
  

Skills

• Strong analytical and decision-making abilities.
• Excellent communication and presentation skills.
• Familiarity with clinical trial management systems and EMRs.
• Deep understanding of GCP, ICH guidelines, and regulatory frameworks
  
  

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003708

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

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

The pay scale for this position is $247,930 - $318,363

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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