Job Detail

Associate Director, Clinical Project Lead

Req ID: 13745
Job Category: Commercial Operations

Location: Zurich, Zurich

Posting Date: June 20, 2018

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Associate Director, Clinical Project Lead

Reports to: Executive Director, Global Franchise CPL Head

Location: Zürich, Switzerland or Boston, US

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 multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion 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). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.

Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.

Position Summary

The Associate Director, Clinical Project Lead is responsible to lead the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility and budget and timeline estimates and operational accountability and management of study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors.  The Associate Director will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance. The Associate Director, CPL may be accountable for setting and managing operations across multiple studies and may be a member of the Core Team depending on the scope of the project.

Job Duties & Responsibilities

• Accountable for the planning, implementation and execution of pivotal clinical trials, including study deliverables, milestones and data quality.  Leads the Clinical Trial Team. Management oversight of CROs and relevant study vendors.


• Oversee third party vendors to operationalize these study specifications.


• Directs the operational execution of clinical study activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity; and patient protection.


• Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals.  Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.


• Manages CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget.


• Communicates clinical studies performance data to other members of the management and scientific team.


• Prepare and maintain required study and regulatory documentation, e.g.:, reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual,  Investigator Agreements and budgets.  Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.


• Conducts lessons learned exercises to provide continuous process improvement and sharing of best practices.


• Participate in and/or lead departmental initiatives.

Essential Qualifications

• >10 years of clinical research experience, 5 of which in a leading role accountable for the planning and execution of global clinical trials.


• Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.


• Ability to lead cross-functional teams and to provide management oversight of CROs.


• Experience in developing study budgets, forecasting and financial oversight of a project.

Preferred Qualifications

• Advanced degree (Master, PhD, MD) is desirable.


• PMP certification desirable.

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. To learn more about Alexion, please visitwww.alexionpharma.comor download our App for iPhones and Blackberries.

Zurich, Switzerland
 

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 multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion 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). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.

Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.