DIRECTOR PHYSICIAN-SAFETY occupation at The Judge Group in Wilmington

The Judge Group is hiring DIRECTOR PHYSICIAN-SAFETY on Sat, 02 Nov 2013 05:34:00 GMT. Leading pharma client seeks a Director Physician-Safety for a 9 month contract opportunity. You will provide technical leadership as either an expert lead for a number of processes or through leadership of a regional based group that ensures effective collaboration between physicians. Will develop and build, or act as a specialist expert, within a cross-functional multi-skilled team comprised of...

DIRECTOR PHYSICIAN-SAFETY

Location: Wilmington, Delaware

Description: The Judge Group is hiring DIRECTOR PHYSICIAN-SAFETY right now, this occupation will be settled in Delaware. For complete informations about this occupation opportunity please give attention to these descriptions. Leading pharma client seeks a Director Physician-Safety for a 9 month contract opportunity.

You will provide technical leadership as either an expert lead for a number of! processes or through leadership of a regional based group that ensures effective collaboration between physicians. Will develop and build, or act as a specialist expert, within a cross-functional multi-skilled team comprised of experts across multi-disciplinary project teams to design, execute, analyses and interpret clinical studies to validate novel therapeutic targets, develop novel biomarkers of pharmacological effects.

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 Go! od Clinical Practices (GCP) and regulatory requirements global! ly.

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, 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.

Accountabilities/Responsibilities
The general responsibilities are those for the Medical Director Patient Safety, though it is expected that given greater knowledge and experience such responsibilities ma! y 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 business plans and priorities
Support a performance-driven culture
• Ensure compliance with g! lobal 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

As a Global Patient Safety Physician

• Ensure ongoing evaluation of the overall safety profile for one or more products, serving as the product safety expert, working in partnership with the Medical Science Director to bring potential safety issues to the attention of the Global Product Team
• Ensure consistency of Patient Safety medical input for the assigned product or products
• For a clinical development product:

a. Be the Patient Safety strategy leader to assigned clinical development project ensuring proactive, ongoing knowledge transfer from relevant discovery functions
b. Design and be accountable for implementation of Patient Safety methodological aspects of assigned clinical! development project reflecting Target Product Profile (TPP) and Target Product Claims (TPC)

In addition, the Senior Medical Director Accountabilities/Responsibilities will include:

• Lead medical expertise and judgment to all surveillance activities, including periodic report production/review, signal detection, SERM activities and the local labeling process
• Lead interpretation of safety-related data, determining significance and implication of findings and communication of conclusions
• Communicate safety-related information to internal and external stakeholders according to standard procedures
• Identify, utilize and maintain external contacts in academia, the medical community, and industry
• Lead safety expertise to clinical or global project teams - in clinical strategies development and working teams, in investigator meetings, in regulatory submissions, in safety reviews and safety issue management teams
• Link! with Data Safety Monitoring Boards and external safety committees, as ! appropriate

Minimum Requirements â€" 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 expedit! ed 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 â€" manages change with a positive approach to the challenges of change for self, team, and the business

Skills and Capabilities

• General medical/therapeutic area knowledge
• Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
• Ability to influence whilst maintaining independent and objective views
• Excellent communication, interpersonal and organizational skills
• Attention to detail
• Delivery focus

The Senior Medical Director must, in addition:

• Be comfortable working on teams
• Have good leadership, writ! ten and verbal and communication skills

Problem solving
!

• Manage a wide range of problems, requiring complex judgments and innovative solutions, needing well-developed conceptual thinking and thus having a high level of business risk management
• Access external resources for advice and respond to external events by adjusting plans or developing new approaches to working

Impact on business results through

• The quality and timeliness of safety data management
• Providing medical expertise to the cross-functional life-cycle management of products

Leadership Capabilities:

• Passion for Customers
• Thinks Strategically
• Acts Decisively
• Drives Performance
• Works Collaboratively
• Develops People and Organization

Organizational Behaviors

• Integrity and high ethical standards
• Excellent team-working skills
• Ability to appreciate diversity and work as equals with global and cross-function! al teams
• Customer-focused
• Demonstrable leadership skills in directing the work of others

Internal and External Contacts/Customers

• Patient Safety personnel, of all levels, across the Regions
• Clinical Development personnel mainly within the Region, but across the Regions on projects where required
• Regulatory Affairs and other personnel mainly within the Region
• External opinion leaders and experts as required

Senior Manager: Internal and External Contacts/Customers

• IT
• Legal
• QA Auditors
• Consultants
• HR
• Global Safety
• Marketing/sales
• Clinical Development and Medical Affairs
• Regulatory Affairs

Contact:
Deirdre Middleton
1-888-228-7162 x1581
dmiddleton@judge.com
http://www.linkedin.com/in/deirdremiddleton
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If you were eligible to this occupation, please email us yo! ur resume, with salary requirements and a resume to The Judge Group.

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This occupation starts available on: Sat, 02 Nov 2013 05:34:00 GMT

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