Job Description: Summary
A senior management role developing and directing Clinical Risk Management through building safety strategies for clinical development programs. This global, expanding pharmaceutical company based in Melbourne, Australia is looking for an experienced pharmaceutical physician with strong development and drug safety expertise to ensure proactive identification, evaluation and management of potential safety signals arising with clinical development programs, to evaluate and maintain the overall risk profile of R&D products and to manage, mentor and develop Clinical Safety Physicians.
Company
A speciality biopharmaceutical company with more than 90 years’ experience developing new important biotech medicines for serious medical conditions is offering excellent relocation packages to fill permanent roles at its HQ. Employing more than 9000 people in 27 countries, the company is rapidly expanding its development portfolio, creating exciting new opportunities in clinical R&D.
Location
Melbourne, Australia
Role
(SDSP) Head Clinical Risk Management
Key aspects of the role
• Strategise and implement a structured approach to support aggregate data analysis, proactive detection of safety signals and risk management for all R&D clinical development programs
• Liaise with Head of Clinical Safety and members of the Clinical Safety Planning and Implementation Team to ensure effective functioning of the department including strategic and long-term planning and resource assessments
• Develop and manage pharmacopidemiologic approaches to solving safety issues; including direct utilisation of signal detection tools, as necessary, to identify and analyse safety issues and to determine and update benefit-risk assessments for R&D clinical development products
• Oversee the responses to regulatory agency inquiries regarding product safety, benefit-risk assessment and risk management
• Line manage, mentor and develop the Clinical Risk Management (CRM) team of Clinical Safety Physicians (CSPs)
• Lead CSPs in the development of program safety management strategies and study specific safety planning and ensure collaboration with Clinical Development colleagues to ensure strategies are aligned with global clinical development plans
• Provide oversight to the interpretation of safety data by the CRM team to ensure that potential safety issues are identified early; the significance/impact analysed and effectively and appropriately communicated
• Ensure CSPs deliver on their study level responsibilities such as protocol and CRF development, Clinical Study Report outputs and contributions to regulatory documents
• Forecast and implement Clinical Risk Management related budget for capital and operational expenditures including resource assessment for staffing
• Collaborate with Clinical Development colleagues to ensure the preparation, execution, and communication of risk management strategies for early development programs and liaise with key stakeholders such as Post-marketing Pharmacovigilance and Commercial operations in the preparation of global risk management plans in support of regulatory requirements
• Support routine and critical response investigational product safety signal detection and review activities through involvement in Safety Management Teams
• Contribute to preparations for external inspections and internal audits
Experience
All applicants must have clinical development and pharmacovigilance experience. Direct experience in risk management in a global setting is preferred.
Candidates must also have experience in preparing clinical sections of regulatory submission documents and responses to regulatory agencies on safety-related topics and aggregate analysis and interpretation of clinical trial safety data. Knowledge and demonstrated use of epidemiological principles, quantitative benefit risk assessment methods and signal detection methodologies in a clinical development setting is essential.
Key requirements are
• Extensive knowledge of drug development processes
• Broad working knowledge of ICH GCP and FDA and EMEA Pharmacovigilance regulations
• Excellent organisational skills and ability to prioritise individual and departmental workloads
• Experience in people management and well-developed skills in teambuilding, motivating and developing people
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously
• Skill in presenting scientific data, creating and delivering presentations
• Excellent interpersonal, oral and written communication skills
• High level of computer literacy
• Willingness to undertake local, interstate and international travel
Qualifications
All candidates must be medically qualified and fully registered. A post graduate qualification is preferred.
Benefits: Bonus:
Pension:
Healthcare:
Life Insurance/Income Protection:
Share Options/Scheme:
Holiday Entitlement:
Other: Generous relocation assistance
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