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.

DIRECTOR/ HEAD OF MEDICAL INFORMATION

SUMMARY

The Director/ Head of Medical Information will report to the Medical Affairs Operations Lead and be a critical component of establishing the Medical Affairs organization at Ionis. This role will lead Medical Information, including developing the overall strategy, implementing systems and processes, and overseeing the development and delivery of Medical Information content for healthcare providers, healthcare organizations, patients, and caregivers. They will need to build relationships and work closely with Medical Affairs Directors, Medical Affairs Field Team, Scientific Communications, Clinical Development, Clinical Operations, Commercial, Patient Advocacy, Compliance, Regulatory, other cross-functional colleagues, and alliance partners to successfully execute their role and responsibilities. The individual who will be successful in this role will have expertise in Medical Information and the pharmaceutical industry.

CORE RESPONSIBILITIES

• Develop and execute the Ionis Medical Information strategy to establish a best-in-class function that meets the needs of Ionis today and in the future.
• Oversee the Medical Information request process workflows for Ionis investigational products to address inquiries from healthcare providers, healthcare organizations, patients, caregivers, and other external parties efficiently and compliantly.
• Ensures responses to medical and scientific inquiries (email, phone, scientific congress booth) are timely, accurate, fair-balanced, and in alignment with applicable guidelines, regulations, and company policies.
• With guidance from Therapeutic Area Medical Directors and in collaboration with internal/external writers, generate, proactively update, and facilitate the review of Medical Information content (e.g., standard response letters, custom responses) assuring quality data, scientific rigor, and appropriate level of compassion.
• Oversee and manage the Clinical Trial inquiry handling processes and workflows to address questions from healthcare providers, healthcare organizations, patients, caregivers, and other external parties efficiently and compliantly.
• Ensures responses to clinical trial inquiries (email, phone) are timely, accurate, tailored to the audience and in alignment with applicable guidelines, regulations, and company policies.
• With guidance from Clinical Operations and in collaboration with internal/external writers, generate, proactively update, and facilitate the review of Clinical Trial Contact Center content (e.g., email and phone transcripts).
• Responsible for the strategic oversight and management of Medical Information and Clinical Trial Contact Centers, medical writing agencies, including vendor training, process/workflow management, development of metrics/ KPIs, resource allocation, and budget management.
• Responsible for generating metric reports to provide actionable insights from Medical Information and Clinical Trial inquiries to inform Medical Affairs activities and other strategic business decisions.
• Serve as the Alliance Medical Information liaison for Ionis products under commercialization agreements with other industry partners to ensure requirements of the agreement are met, including, escalation handling, and generation and maintenance of Medical Information and serving as the Point of Contact for Scientific Services for the European Medicines Agency.
• Provide Medical Information support at top-tier medical and scientific congresses including staffing the Medical Information Booth.
• Hire and staff team to address Medical Information needs.
• Train and mentor new employees to ensure successful onboarding. Coach and develop existing employees including the completion of timely performance evaluations.

REQUIREMENTS:

• Clinical advanced degree preferred: PharmD, PhD, NP, PA, RN, MPH
• A minimum of 5 years of experience within the pharmaceutical industry with at least 3 years of direct experience in medical information, which may include post-doctoral training (e.g., PharmD fellowship in Medical Information or Medical Affairs, etc.)
• Previous experience working with rare and ultra-rare diseases (preferred)
• Previous experience in overseeing call centers, external agencies, and internal employees
• Exhibits advanced knowledge of Medical Information work and processes, and the applicable industry guidance and regulations
• Excellent interpersonal, analytical, and communications skills with flawless attention to detail
• Demonstrated project management experience, including excellent planning, organization and budget management skills, and the ability to support and prioritize multiple projects with minimal supervision
• Proven ability to interface in multi-functional teams and influence others to work collaboratively
• Demonstrated strong verbal, written, and presentation skills
• Strong attention to detail and ability to work independently
• Must be an energetic individual with strong interpersonal skills.
• Must be a self-motivated, approachable, articulate team player who has the highest level of integrity and core value system consistent with our culture and core principles.
• Able to travel and attend conferences to represent Ionis Medical Information (~10% travel)

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS00####

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 $192,863 to $238,827

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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