Medical Director/ Senior Medical Director
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About Us
Alexion is a global biopharmaceutical company that combines groundbreaking science with a steadfast commitment to meeting the needs of patients living with severe, life-threatening and often ultra-rare diseases. Alexion scientists are among the first in the world to unlock the therapeutic potential of inhibiting terminal complement, a group of proteins that play an important role in the body's immune response and can destroy healthy tissue in certain patients.
Alexion discovered and developed Soliris® (eculizumab), a first-in-class terminal complement inhibitor approved in the United States, European Union, Canada and Australia as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH). Alexion is working urgently to investigate Soliris and additional biopharmaceuticals as treatments for patients with other rare and severe diseases, including cancer.
Summary
Responsiblities:
blank_pageAlexion is looking for experienced and motivated physicians to lead new and expanding clinical development programs in the areas of hematology, oncology, nephrology, neurology and transplantation. Our medical directors guide the development of new and marketed products in the United States and around the world. These positions report directly to the Chief Medical Officer and are based in key locations in the United States and at our headquarters in Cheshire, CT.
Medical Directors serve as the internal and external medical champions at Alexion with responsibilities in Clinical Development; Trials Planning, Implementation and Follow-Up; Safety Reviews; Post Marketing and Commercial Support Activities.
Depending on experience and therapeutic area, specific responsibilities include:
Drug Development Planning
•Assist in planning the overall strategy (clinical and otherwise) for products in clinical development.
•Assist in IND and NDA filing activities for drug candidates
•Interact with FDA (by teleconference or attendance at meetings).
•Assist in due diligence of potential in-licensing drug candidates.
•Interact with academic experts and advisory panel members at international symposia.
Trial Start-Up
•Assist in protocol development, including protocol outline, protocol and protocol amendments, which will require interaction with Medical Directors, Clinical Project Leaders, Safety Officers, Statistics, Regulatory, Project Management, Clinical Supply and Marketing personnel.
•Participate in investigators' meetings, as well as internal and external educational seminars related to study protocol.
•Oversee recruitment of participating investigators and the compilation and distribution of study start-up packages.
•Identify and interact with outside experts and opinion leaders.
Trial Conduct
•Serve as the primary medical contact with collaborators and opinion leaders.
•Serve as medical expert with internal and external (CRO, independent contractors) staff regarding protocol related issues.
•Assist in developing and monitoring adherence to program timelines (e.g., enrollment, data cleaning, and statistical output timelines).
•Oversee investigator recruitment efforts and resolve recruitment problems in conjunction with the Clinical Project Leader.
•Track and compile patient screening and enrollment information.
•Perform data listings review and assist in study report generation, as needed.
Trial Reporting
•Assisting in creating and reviewing all study related documents, including justification documents, CRF's, study tables and listings, statistical analysis plans, and final study reports.
•Prepare pertinent safety and/or efficacy summaries for official documents.
Budget Responsibilities
•Assist in preparing site-specific study budgets.
•Assist in preparing departmental budgets and short and long term budget projections for ongoing projects.
Safety Review
•Periodically review all study related patient safety data.
•Interact with Safety Officer and Regulatory Affairs regarding reporting of serious adverse event to FDA.
•Visit selected sites, with or without a field monitor, to trouble-shoot, train/retrain staff, if needed.
Post-Marketing Activities
•Serve as internal and external medical champion at Alexion, including serving as a key medical speaker on marketed products in a multiplicity of venues and providing medical and scientific input and support for presentations at international/national and regional meetings, such as Speaker's Training, Advisory Boards, etc.
•Lead discussions with and influence academic and clinical opinion leaders, prescribers, and colleagues at the FDA.
•Interact with internal Pharmacovigilance group in the review of post-marketing safety-related occurrences.
•Define publication strategies and develop medical positioning for the Company's products.
•Manage the marketing product publications program; review content of journal articles and other communication materials, including promotional pieces, from an accurate medical/ clinical/scientific supportability perspective.
•Review medical information/communications responses to FAQs on marketed products.
Requirements
M.D. degree and board eligibility in internal medicine, hematology, oncology, nephrology, and/ or neurology.
•Industry-based clinical development experience in a pharmaceutical or biotech setting.
•A proven record of direct experience working with clinical trials as an Investigator, Sub-Investigator, or Medical Monitor is desirable.
•Working knowledge of general medicine and drug therapy, including pharmacology, toxicology, trial methodology and clinical pharmacology, and an in depth knowledge and understanding of scientific principles for controlled trials, is essential.
•A high level of professionalism, and the ability and willingness to work effectively in a team setting.
•Knowledge of regulatory requirements for NDA submission and experience interacting with regulatory agencies will be beneficial.
•Ability to travel.
•Strong interpersonal skills with a proven background of interacting successfully with individuals at a variety of functional levels, both internally and externally.
•Excellent written and verbal communication skills.
About Alexion Pharmaceuticals
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Employing more than 500 people worldwide, Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris(R) (eculizumab) is Alexion's first marketed product for patients with paroxysmal noctural hemoglobinuria (PNH) a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. Soliris is approved in the U.S. and Europe in 2007, and Canada and Australia in 2009. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development.
Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, and a 401(K) plan.
Alexion is an Equal Opportunity/Affirmative Action Employer.
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