Alexion Pharmaceuticals Associate Director, Operational Excellence in Boston, Massachusetts
The Associate Director, Operational Excellence, will be accountable for leading key strategic global operational excellence activities across Research & Development (R&D) functions and regions, including integration of Business Development and Licensing (BD&L) activities, process improvement projects, and quality initiatives.
Job Duties & Responsibilities
Leads cross- functional assigned project workstream(s) to successfully deliver new process, systems and BD&L activities into the Alexion organization.
Accountable for creating cross-functional plans, budgets and resource estimates for integration of BD&L assets working across Alexion functions, external vendors and acquired. companies/partners. Drives plans to timely and successful completion.
Leads R&D workstreams to deliver major, cross-functional process, system or quality improvement activities.
Leads root cause analyses and remediation CAPAs for cross-functional quality issues.
Develops and grows the relationship with external partners and with other Development functions, to facilitate expansion of solutions across the R&D organization.
Navigates uncharted territory where no process or precedent exists, whilst maintaining compliance with current internal procedures and industry regulations/guidance documents.
Identifies opportunities for, and ensures integration with, other workstreams.
Develops and maintains a project plan related to individual operational excellence projects, e.g. methodology assessment, prioritization of activities, resources, ensure implementation of the improvements is effectively executed and define/maintain ongoing measurements of success.
Prepares and continually improves/refines detailed “playbooks” of templates and best practices for integration.
Defines processes and establish progress monitoring to ensure successful integrations via acquisitions; track and report progress on key acquisitions.
Develops strong partnership with stakeholders, enabling collaborative scope and change management.
Reports project status on a regular basis to the project team and R&D management.
Professional in a clinical research environment preferably with >10 years’ experience as a Project Leader, Project Manager or similar function.
Experience with change management initiatives. Strong ability to analyze unstructured problems, identify root causes and align others to drive solutions.
Strong interpersonal and proactive problem-solving skills.
High tolerance for ambiguity and ability to create clarity for others. High level of organizational maturity and ability to apply judgement
Understanding of the drug development process and working knowledge of the essential activities for all key functional areas.
Thrives in complex, fast-paced environment.
Ability to think creatively on how to identify and mitigate projects risks while maintaining quality.
Leadership, project management in a matrix environment are required.
Excellent oral and written communication and interpersonal skills.
Inspire others to share their vision and support them to reach a common goal.
Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
Advanced degree (Master, PhD, MD) is highly desirable.
Six Sigma, PMP Certification or equivalent desirable
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.