Senior Medical Director, Hematology-Oncology

Overall Description
This person will be the internal and external medical champion of all hematology/oncology products at Alexion. This person will lead discussions with and influence academic opinion leaders, prescribers, and colleagues at the FDA. This person will be responsible for leadership and medical monitoring of one or more Phase II - IV clinical drug trials. He or she will assist in protocol development, study conduct, and data interpretation, and will interact with study sites (principal investigators), vendors (e.g. central laboratories, CRO?s), and other departments within Alexion.

Position Responsibilities

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. This 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.

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 events to FDA. Visit selected sites, with or without a field monitor to trouble-shoot, train/retrain staff, if needed.

Trial Reporting
Assist 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.

Post-Marketing Activities
This person will be the internal and external medical champion of all hematology/oncology products at Alexion. This person will lead discussions with and influence academic opinion leaders, prescribers, and colleagues at the FDA. This person will interact with internal Pharmacovigilance group in the review of post-marketing safety-related occurrences.

 

Educational Requirements
MD degree and board eligibility in internal medicine, oncology, hematology or hematology-oncology.

Work Experience


A proven record of direct experience working with clinical trials as investigator, subinvestigator or medical monitor is desirable. A 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. Knowledge of regulatory requirements for NDA submission is beneficial. Professionalism is essential, as is willingness to work in a team and travel.

 

Alexion Pharmaceuticals is a publicly traded company engaged in the development of novel drugs for the treatment of hematologic disorders, autoimmune diseases, cardiovascular disorders and cancer.

Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, a 401(K) plan and stock options.

Alexion is an Equal Opportunity/Affirmative Action Employer.