Employment

Title of Position:  Director/Senior Director, Product Safety

Job Code: 08016

Location:  Rockville, MD

Applicants must meet the following requirements:

• M.D., with sub-specialty board certification, preferably in hematology/oncology or infectious diseases
• Minimum 10 years of relevant experience, with a concentration in oncology, autoimmune or infectious diseases
• Thorough exposure to all the specialized disciplines that participate in product safety and clinical development
• Experience in meeting the unique product safety, clinical development and regulatory requirements of biological products
• Strong experience in clinical development and clinical research is highly desirable 
• Extensive experience managing  and developing professional product safety staff
• Must be well-regarded by therapeutic thought-leaders for intellectual strength and achievement as a clinical or safety scientist and be capable of quickly establishing credibility with new therapeutic groups
• The ability to communicate both orally and in writing to a high standard, and handle group and individual presentations effectively
• The ability to interact effectively with development and marketing partners
• Strategic ability, sound judgment, and initiative
• Superior people management and leadership skills

The selected candidate will be responsible for:

• Comprehensive oversight responsibility for product safety activities and contribution to overall planning and execution of clinical development leading to regulatory approval, either directly or through the management of clinical development staff.
• Clinical responsibilities include medical interpretation of safety cases, oversight of the preparation of safety reports, and participation in clinical research activities beyond the area of product safety and pharmacovigilance.
• Participating in the development and management of budgets and forecasts for product safety functions 
• Management of the global serious adverse event reporting system
• Safety Review Committees
• Compliance with Global Safety Regulations
• Corporate communications - including participation in committees and exchange of critical safety information
• Supervision, management and participation in the global serious adverse event reporting system, including:  medical and safety evaluation of serious cases as the Medical Monitor .
• Participation in call schedule as a first responder for safety issues after hours, including weekends and holidays.
• Keeping current regarding proposed changes to domestic and international safety reporting requirements, and making required changes to safety processes and systems.
• Collaboration on the development of product Risk Management Plans (RMPs).
• Development of the Product Safety department infrastructure, including:  development of Product Safety department position descriptions, development of proposals and justifications to support needed safety positions, recruitment and hiring activities, and supervision, mentoring and ongoing training of Product Safety staff.
• Oversight of the selection, development, validation, implementation, and training of safety software and other process systems in collaboration with managers from appropriate departments.
• Oversight of development of standard operating procedures for core safety surveillance processes, and ensuring that staff maintain safety files and documentation that are compatible with the corporate document management system.
• Participation in safety-related budget and forecasting activities.
• Development of Product Safety training presentations for Macrogenics staff, external contractors, and clinical study investigator meetings. 

 Benefits:  Competitive salary and benefits package

Qualified applicants with current permission to work in the United States, please send your resume and salary history to:

Human Resources 
MacroGenics, Inc.
1500 East Gude Drive
Rockville, MD 20850
E-mail:  HResources@macrogenics.com

MacroGenics, Inc. is an Equal Opportunity Employer.