Alexion Pharmaceuticals Associate Director, Clinical Operations in Boston, Massachusetts
This position can be based at any US Alexion office location, OR remote
Position Summary The Associate Director (AD), Clinical Operations, supports the operational aspects of all clinical studies worldwide through providing resources, standard processes and direction for clinical trial execution through the direct line-management and oversight of Clinical Trial Managers. This individual works under the direction of the Director, Operational Excellence with autonomy and independence and is part of the CTM leadership team. The Associate Director supports and participates in development and implementation of process improvement activities across organizational functions, e.g., Legal, Global Drug Supply, Global Strategic Sourcing.
Job Duties & Responsibilities • Supports the operational aspects of global clinical operations by overseeing CTMs and providing direction and guidance • Hires and provides leadership and mentoring to Clinical Trial Managers • Accountable for ensuring team member compliance with training requirements in the Learning Management System, Alexion U • Facilitates and assists Clinical Trials Managers with definition of work specifications, communication pathways, and issue escalations as appropriate • Conducts performance appraisals and works to develop team. Makes recommendations to Director regarding promotional and developmental opportunities • Serves as SME to facilitate process improvements in key areas across cross-functional asset lines, includes SOP and work flow development • Contributes to cross-functional operational excellence efforts through process improvements related to systems and processes • Leads and/or participates in other department initiatives
• 10+ years of clinical research experience in the pharmaceutical industry with a solid understanding of technology and processes used in drug development
• 3-5 years of people management experience
• Demonstrated leadership skills to manage, motivate, and mentor staff and to facilitate and prioritize tasks and/or work independently
• Advanced ability to work in a matrix environment and develop constructive partnerships with internal and external stakeholders. • Exceptional written and oral communication skills.
Preferred Qualifications • Bachelor’s degree in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
- Prior experience working with CROs, vendors, and project stakeholders to drive timelines, deliverables and overall quality.
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.