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 of becoming a leading, fully integrated biotechnology company.

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.

VICE PRESIDENT, HEAD OF PHARMACEUTICAL DEVELOPMENT

SUMMARY:

Oversee Pharmaceutical Development Department staffing, budgeting, planning and execution of drug product and device development strategies in a collaborative manner across internal disciplines and with pharma partners and contractors. Ensure successful planning and management of all project aspects related to the drug product configuration – including specifications, stability, manufacturing, packaging/labeling to assure clinical supply and enable successful clinical regulatory filings. Establish a quality target product profile (QTPP), including delivery devices where appropriate, to underscore a development plan with strategic CMC and technical direction for the product configuration.

RESPONSIBILITIES:

• Serve as the pharmaceutical development representative for internal and partnered project teams, assuring alignment of work scope to resources and budget.
• Lead budgeting and staff recruitment/ development to ensure a higher performing drug product function
• Assure formulations for preclinical-tox are suitable to represent the clinical dosage form and route of administration.
• Oversee the requisite formulation development work suitable for the intended clinical dosage form while leveraging and adding to the existing oligo platform knowledge
• Drive appropriate clinical formulations, manufacturing process, product specifications, and delivery devices.
• Ensure timeliness and continuity of clinical drug product supplies with appropriate controls.
• Ensure creation of drug product CMC regulatory submission sections for clinical and commercial applications
• Effectively manage contract manufacturing organizations (CMO) in line with internal and partner timelines and associated contract facilities.
• Manage and develop a team of pharmaceutical development staff that is matrixed across multiple programs
• Ensure GMP compliance to 21CFR part 211 and 820 (quality system regulations)
• Work closely with QA and lead technical aspects of product/process investigations.
• Other duties as assigned.

REQUIREMENTS:

• MS/PhD degree in relevant field of science or engineering
• At least 15 years’ experience in pharmaceutical technical development disciplines
• At least 5 years of leadership experience at the department and/or larger team level, including recruiting/coaching high performing teams and creating/managing program budgets
• Extensive experience designing and developing sterile parenteral / injectable drug products, including
  • Drug-device combination products such as prefilled syringes, autoinjectors, nebulizers
  • Research and development for novel parenteral formulations and routes of delivery
  • Prior experience developing oligonucleotides is a strong plus
• Demonstrated general ability to apply fundamental scientific and engineering know-how to generate innovative yet practical solutions to technical challenges.
• Expert at defining and leading cross-functional drug product development functions from preclinical through commercial launch: manufacturing, specifications, development studies, stability, shelf-life, etc.
• Substantial experience managing technical development and cGMP manufacturing operations, including selection and oversight of CROs and CMOs
• Working knowledge of cGMP requirements and stage appropriate CMC regulatory requirements for pharmaceutical and combination medical device development and manufacturing
• A highly motivated self-starter with strong interpersonal skills including the use of influence and negotiations to successfully align and complete projects with both internal and external collaborators and “customers”
• Proven ability to manage and simultaneously advance multiple tasks and projects and “flex” between strategy and operational execution
• Skilled in clearly conveying complex concepts and study results in written and verbal form to a range of audiences including executive management and regulatory agencies.