Associate Director Physician

Company Name:
Responsible for managing global or regional therapeutic/ research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. Ensures projects adhere to Good Clinical Practice and regulatory requirements. Will be responsible for overseeing development of the functional strategy or act as renowned expert in own field.
Medical Director and Senior Medical Director- Patient Safety
Therapeutic Area
Infection experience preferred but not required.
US based medical training and clinical practice preferred but not required.
100% on-site required at start; no relocation (so commutable home location required); flexibility around off-site work after first months on job
Patient Safety physicians are involved in all safety surveillance activities, including medical review of individual safety cases and cumulative case listings, the production of periodic reports, signal-detection and safety evaluation and review meeting (SERM) activities, and setting the safety standards and strategy for clinical development in accordance with the Clinical Project Operating model. These individuals must ensure that all safety surveillance activities are conducted to the highest ethical and safety standards in compliance with Good Clinical Practices (GCP) and regulatory requirements globally.
The Medical Director Patient Safety is at level 2 in the Patient Safety Physician Ladder in Patient Safety. The Senior Medical Director is at level 3 in the Safety Physician Ladder in Patient Safety. These persons ensure the ongoing safety evaluation of a product or group of products by providing Patient Safety medical expertise and judgment to safety surveillance and clinical development activities, including ongoing patient risk management. The job-holder can expect to get broad international exposure to other functions involved in the R&D; process within COMPANY, get an overview of how strategic direction is set within Patient Safety and how decisions are made during a drug development regarding the emerging safety profile of a product during its life-cycle.
The general responsibilities are those for the Medical Director Patient Safety, though it is expected that given greater knowledge and experience such responsibilities may be carried out at a higher level in the business, with greater cross-functional interaction and through supervision of Patient Safety colleagues. Depending on the role, the job-holder may have Global Patient Safety Physician responsibility for one or more products.
Provide medical expertise and judgment throughout the case-handling process with medical review of individual cases and cumulative line listings
Provide medical expertise and judgment to all surveillance activities, including periodic report production/review, signal detection, SERM activities, the local labeling process, and the production and maintenance of Patient Risk Management Plans
Provide medical expertise and judgment to enable high-quality and timely responses to safety queries
Provide scientific and surveillance contributions for one or more products in accordance with the Clinical Project Operating Model and in support of COMPANY business plans and priorities
Support a performance-driven culture
Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, procedures and processes
Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development
Minimum Requirements - Education and Experience
Medical degree
At least 2 years of clinical experience post-registration/certification
High level of medical competence, with an ability to balance this with industry standards to achieve business goals
Two or more years of drug development and/or Pharmacovigilance experience obtained while working in the pharmaceutical industry and/or academia
The Senior Medical Director must, in addition, meet the following requirements:
3 years clinical practice experience
Medical residency training or equivalent experience
At least 5 years of drug development and/or Pharmacovigilance experience (the majority of which should be in Pharmacovigilance) with clear evidence of delivery
A thorough knowledge of the pharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities
Working knowledge of epidemiology
Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team, and organizational objectives
Experience of managing change - manages change with a positive approach to the challenges of change for self, team, and the business
Min Salary: $0.00
Max Salary: $0.00
City: Gaithersburg
State: MD

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