Company: Advanced Clinical Recruitment Ltd
Reference: Immuno-Oncology - Lead Safety Physcain
Closing Date: 03 Feb 17
Type: Full Time
Salary (£): Competitive
This is an excellent opportunity for a experienced physician with extensive experience with Immuno-oncology to join a business, paving the way in this therapeutic areas development. If you would like to have a further discussion about the role, please feel free to email me at email@example.com or alternatively call me on 01142945005.
Main Duties and Responsibilities
You will take ownership of the patient safety risk assessment for the assigned trials/product(s), strategically as well as for emerging safety information. You will bring deep clinical understanding and judgment to the patient safety risk perspective in benefit risk assessments. You will be responsible for overseeing development of the functional strategy or acting as a renowned expert in own field. Contributing to strategy and plans to optimize the safety profile of immuno-oncology drugs in development.
Core Responsibilities include:
· Serve as a trial level physician to support the design, implementation and interpretation of clinical studies with a focus and expertise on Patient Safety/Pharmacovigilence. Have responsibility for protecting the patient safety, integrity and conduct of clinical studies.
· Partners with function Study Physician and cross functional stakeholders including Patient Safety/Pharmacovigilence and Global Medical Affairs. To develop and implement a strategy and plans to optimize the safety management of relevant TA compounds/drugs.
· Establish and work with study physicians and clinical scientists in the development of clinical program patient safety related documents including informed consent forms and safety reports
· Defines strategies or leads business response to complex technical issues for specific safety aspects in relation to current projects, new projects and various plans within the scope of the IO global medicines development unit (IO GMed).
· Provides expert advice in the area of specialism, influencing the development of statistical analysis related to patient safety, to the global business and the Immuno-oncology TA.
· Liaises with the internal and external medical community to follow developments within areas of expertise.
· Establish and work with study physicians and clinical scientists to ensure appropriate standards for patient safety monitoring within Immuno-oncology study team.
· Contributes to or manages the development of the senior management team in area of expertise
· Maintain up to date awareness of all important advances within a given disease area through review of scientific literature, attendance at critical meetings and relationships with key external experts.
· Within assigned areas disseminates new information within the Immuno-oncology TA to transform trends and emerging data into new plan
· Contributes to regulatory communication and preparation of higher level documents.
· Key Liaison for Immuno-oncology GMed to relevant AZ Science Units (MedI, iMed and GMD functions such as Patient Safety/PV)
· Uses expertise and knowledge of global safety issues to support development of strategic objectives for inclusion into annual business objectives
· Degree in medicine and experience as a physician or academic
· Extensive experience in designing, monitoring and implementing clinical trials and interpreting trial results
· Therapeutic area expertise and commercial understanding
· Thorough understanding of pharmaceutical safety, reporting and surveillance processes, extensive experience of Patient Safety as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agency
· Understanding of the medico-legal aspects of pharmacovigilance
· Proven leader of cross-functional delivery teams. Project Management Competent level.
· Professional at innovation, integrating experts; co-ordinate PSDA discussions into Enabling Safety Science priority setting.
· Professional in PS/PV capability including having significantly contributed to safety components of regulatory submissions and PRMP production
· Experience of benefit:risk evaluations
· Extensive general medical oncology knowledge
· Able to work across TAs and Functions
· Research background including peer reviewed publications
· Significant experience in advanced research and development
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