Alexion Pharmaceuticals Senior Director, Drug Delivery and Device Development in New Haven, Connecticut
The Senior Director, Concept and Development Lead position is a high impact, leadership role, responsible for leading key elements of the Combination product/Device strategy and development with a Patient Centricity focus.
The Senior Director will serve as the key Device Development interface for the R&D drug portfolio, Patient Insight Team, Star Team, Human Factor group. This group will be responsible for defining our combination product/device platforms, user preference device related study in partnership with other Alexion Team to meet our evolving portfolio needs
The Senior Director will lead with his/her Team the Human Factor Strategy and other key activities to ensure on-time and successful Regulatory filing and approval. She/He will interact with commercial teams and Patient Insight Team to understand Patient journey to recommend drug device Combination product/device solutions. When needed, this position will help to develop/participate in business processes with Alexion internal partners to link drug strategy (R&D/Therapeutic Area/commercial) and the combination Product Team/PDCS. Prioritizing Projects and Combination Products/Devices Roadmap.
The Senior Director and his Team will support Platform Device Feasibility testing leveraging the resources from the Device Organization and external resources and Lab testing when needed.
The responsibility will extend to the labeling and secondary packaging when relevant for patient experience and Human Factor validation. When needed for Device related, She/He will review clinical and commercial complaints to understand trend and propose/support corrective solution/improvement on Devices, IFU, packaging, training material.
She/he with her/his Team will provide data/statistical analysis to support the different project as needed.
She/He and his/her Team will be the primary container center of excellence supporting the project Team as an advisor.
As a Member of the Device Development Organization, the Senior Director will represent Alexion on essential biopharma industry technical exchanges
Principal responsibilities of the concept de development Lead is to serve as the key contact for the Device and other functional organization for Human Factor, Device Strategy for Early molecules, Life Cycle device improvement/New Device, Human Factor and post market data analysis.
Master’s Degree in Engineering (Mechanical, Biomedical or Chemical) with a minimum of 15 years of experience in drug device combination product/device development and commercialization with demonstrated success leading multi-site, global or enterprise-wide programs in the biotech/pharmaceutical industry.
Minimum of 8 years of direct cross-functional program management experience in the development and commercialization of device branded products.
Experienced in functional area with proven experience in the development and launching Devices and/or drug device Combination product
Strong Human Factor experience
Deep technical and Statistical analysis skills (Minitab, JMP, Crystal Ball,…) and experience on root cause analysis and implementation solution.
Proven Leader with ability to manage multiple complex project and root Cause analysis skills (DMAIC, DFFS)
Experience in interacting with R&D to understand early Device/Combination product needs and develop roadmaps
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.