Alexion Pharmaceuticals Executive Director, Clinical Data Management in Boston, Massachusetts
Accountable for the global delivery, integrity and quality of Alexion’s clinical data across the portfolio from Phase I through IV. Leader of the data management function in Alexion with accountability for people and budget. Provides leadership of the continued evolution of Alexion’s data processes, systems and organization in alignment with other Development functions. Reports to the Head of Development Operations and Quantitative Sciences.
Job Duties & Responsibilities
Deliver all phases of Alexion’s data management functions supporting global clinical trials from Phase I through IV including Protocol Review, CRF design, Database build, Data Entry, Data Verification, Data Review, Query Management, Coding, SAE Reconciliation;
Manage build and develop a highly effective team data management team aligned with the needs of the portfolio. Accountable for the functional budget;
Drive execution of deliverables through a largely outsourced operating model. Implement strategies to optimize external support with Contract Research Organizations or other external resources globally;
Ensure compliance with Alexion and industry quality standards, guidelines and procedures;
Drive operational excellence and champion the continued innovative evolution of Alexion rare disease processes including central data review, risk-based approaches, new technology/ roles in alignment with other functions;
Develop, implement and execute data management strategies to allow Alexion to better leverage clinical data including centralized monitoring/risk-based monitoring;
Communicate and collaborate effectively with internal team members, senior and executive management, and external experts and stakeholders.
Bachelors of Science degree required, Master in Science in health related field, preferred together with 15 years’ of pharmaceutical experience including ten (10) years' of supervisory and management experience in the pharmaceutical research environment;
Strong data management and EDC experience required including CDISC, 21 CFR Part 11, ICH/GCP guidelines, and clinical trial methodology. Medidata Rave experience is preferred;
Strong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation;
Experience partnering and driving CRO relationships and other external resources;
Experienced enterprise leader capable of integrating across functional boundaries;
A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy setting to build a solutions based environment;
Excellent verbal and written communication skills, and excellent inter-personal skills;
Flexible, well-organized, and able to lead well under pressure.
Up-to-date with industry advancements around data standards and data related technologies including their implementation;
Experience working in a clinical development organization with a heavy emphasis on support of multiple, ongoing projects.
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer