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.

ASSOCIATE DIRECTOR, CLINICAL SUPPLIES

SUMMARY:

The Associate Director, Clinical Supplies role is a leadership position within the Clinical Supplies department. The incumbent is experienced in drug development and clinical supply chain management and understands clinical supply chain systems and process interdependencies. The Associate Director will be assigned multiple projects which may vary from early to late stage development, including pre-commercial launch readiness activities.

The incumbent will drive supply planning and inventory management for clinical studies and will be the department lead for systems associated with IXRS/IRT, eTMF, inventory and finance. Key responsibilities include creating specifications for IXR/IRT systems, managing eTMF related activities for the department, budget creation and tracking, establishing global supply strategies to support clinical sites, coordinating clinical supply chain activities with multiple functional groups such as, Manufacturing, Quality, Regulatory and Clinical Development and defining, scheduling and managing global packaging and distribution activities executed by contract research organizations. Additionally, the incumbent must demonstrate working knowledge of global regulatory requirements pertaining to packaging, labeling and distributing clinical trial material. As a member of Clinical Supplies, this individual will represent the department on multiple project teams and must demonstrate the ability to work in a dynamic matrix environment, be creative and flexible when problem solving and work collaboratively as part of a team.

RESPONSIBILITIES:

• Drive development of interactive response systems (IXRS/IRT); coordinate system builds with Clinical Development, Biostats, Clinical Operations and Quality, create standard system specifications and perform User Acceptance Testing (UAT)
• Conceive, direct and execute clinical supply design strategies. Manage GMP inventory and track ongoing and upcoming manufacturing activities including development of short-term and long-term supply strategies.
• Provide input into protocol design for projects across the portfolio as they relate to clinical supplies
• Develop and manage clinical supply packaging and labelling operations and worldwide distribution activities; establish risk/mitigation plans to ensure uninterrupted supply
• Provide regulatory submission information (e.g. label text, expiry tracking) to Regulatory Affairs and Pharmaceutical Development; ensure uninterrupted supply to global clinical sites
• Provide expertise in US and ex-US regulatory requirements for packaging, QP release of material, label text requirements and distribution logistics.
• Assist in developing multi-year rolling forecast for the portfolio; collaborate across departments to ensure adequate availability and timing of clinical supplies in support of project and corporate goals.
• Execute on vendor management programs; participate in vendor improvement plans, metrics evaluation and oversight
• Track purchase orders, invoices, and other finance related activities to ensure departmental fiscal responsibility
• Establish new processes; evaluate process improvements for existing procedures.
• Communicate effectively, timely and seamlessly with external stakeholders, corporate partners as well as team members including senior management
• Develop and manage performance of staff supporting a broad range of activities associated with clinical drug supply and vendor management.

REQUIREMENTS:

• Bachelor’s degree required; advanced pharmacy degree preferred
• A minimum of 10 years relevant drug development experience in clinical supplies
• Strong knowledge of clinical supplies, pharmaceutical technology, and interactive randomization systems.
• Strong knowledge of regulatory requirements and quality systems; must work independently under cGMP and company SOPs.
• Proven ability to be productive and successful in an intense work environment
• Proven ability to initiate, plan and execute multiple projects with ease
• Proven ability to work in a matrix environment and work collaboratively across all levels of the organization
• Communicate effectively and strategically in addition to working tactically throughout the supply chain life cycle. Adept at solving complex problems in creative and effective ways
• Exceptional interpersonal, organizational, analytical and problem-solving skills
• Excellent oral and written communication skills
• Proficient in Word, Excel, PowerPoint, MS Project and SharePoint; experience in inventory management systems or ERP systems a plus

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS002631

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 $155,000 to $183,000

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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