Product Safety Physician (018-13-02) MacroGenics
Job Code: 018-13-02
Location: Rockville, MD
Applicants must meet the following requirements:
M.D., with sub-specialty board certification, preferably in Hematology/Oncology or Rheumatology/Immunology.
3-5 years of clinical trials drug safety experience in industry or equivalent is preferred
3-5 years clinical experience in patient care setting is preferred.
3-5 years of management experience is preferred
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, especially in area of Immunotherapeutics
Excellent organizational, communication, and professional interpersonal skills.
Ability to manage several fast-paced, high-priority activities within required timelines.
Ability to manage people and processes to meet corporate objectives.
Ability to work independently with minimal supervision. For complex issues beyond position scope that requires input from senior management will provide a summary, assessment and recommended plan of action.
Ability to problem-solve issues of diverse scope and complexity.
Strategic ability, sound judgment, and initiative.
Strong PC skills utilizing Microsoft Office Products (Word, Excel, Outlook, PowerPoint and Access).
Solid knowledge of applicable domestic and international safety reporting regulations/guidance (e.g. FDA, ICH, CIOMS and GCP guidelines)
The selected candidate will be responsible for (including supervising others):
Medical interpretation of safety cases and oversight of the preparation of individual and aggregate safety reports
Medical and safety evaluation of individual case safety reports (ICSR); in collaboration with Medical Monitor and/or Sr VP of Clinical Development, provide company causality assessment
On-going review of safety data from a wide variety of sources, relevant to MG products in development
Identification of sub-groups or specialty populations requiring additional focused safety reviews, analysis, and/or monitoring, as applicable
Oversight of safety signal detection for the company, including the development of safety signal reports and execution of any relevant recommendations
Assistance with aggregate and ad hoc safety report production and review; provision of safety input on various safety and clinical documents, including but not limited to: clinical protocols, informed consent documents, investigator?s brochure, product label, safety data exchange agreements
Provision of the benefit-risk and safety profile assessments for MG products; development of regulatory compliant benefit-risk assessments, risk management plans and risk evaluation and mitigation strategies
Provision of after-hours medical oversight and consultation for safety inquiries, including weekends and holidays
Co-chair the Safety Review Committee (in conjunction with Director of Product Safety)
Provision of corporate communications regarding issues regarding safety, including participation in committees and exchange of critical safety information
Promotion of evidence-based practice, supported by thorough review of literature, including disease indications for MG products, mechanism of action, drugs in class, and current standards of care
Provision of updates to reference safety information and the development of appropriate labeling (e.g. DCSI, CCSI, PI) for MG pre- and post-marketed products in the US and outside the US
Assurance of compliance with Global Safety Regulations; maintain competence and currency on proposed changes to domestic and international safety reporting requirements.
In conjunction with Director of Product Safety, assist with the development of the Product Safety department infrastructure/activities, including: staffing, budgeting, PV modeling, safety software selection/implementation, process development, and training.
Additional responsibilities as required by business need.
Benefits: Competitive salary and benefits package
||1500 East Gude Drive |
Rockville, MD 20850