MSI are working with a well known Global Pharmaceutical company to source an experienced Safety Physician to join their team as a Therapeutic Area Strategy Lead. The main responsibilities of this role are:
- Deputize for the TA Head:
- In times of absence or unavailability
- Matrix Leadership of Global Safety Officers (GSO)
- Maintain Therapeutic Area expertise, product portfolio-specific expertise and ongoing assessment of therapeutic areas, competitive drugs and therapies and applicable regulations
- Assist TA Head to develop and support processes that ensure state-of-the-art PV contributions
- Assist TA Head in preparing for Advisory Committees / Oral Explanations / Major regulatory meetings
- Foster communication and collaboration with other TA Strategy Leads to standardize best practices
- Foster communication and collaboration with other TA Strategy Leads on GSO challenges with regard to daily activities
- To prepare for ebbs and flow of GSO activities and resource needs
- Structured Benefit-Risk:
- Design plan to drive alignment of stakeholder thinking on benefits, risks, uncertainties
- Champion the implementation of structured benefit-risk assessment
- Partners with TA Head to determine extent and appropriate methodology for structured benefit-risk assessment
- Project planning for structured benefit-risk assessment, including for which products (calendar of preparation, assessment timing, and milestones)
- Liaise with GSS Safety Analyses Innovation and Submission Readiness Lead for GBU/TA specific:
- Submission readiness activities
- Drive performance of analyses important for the submission
- Ensuring execution of the overall safety strategy in alignment with Key Messages
- Ensuring that key messages are robustly supported by data; when not supported by data, that key messages are challenged appropriately
- Safety and benefit-risk consultant readiness
- Biostatistics and Epidemiology coordination and liaison
- Liaison to Epi & B-R team for execution of TA-specific B-R strategy
- Interact with clinical development, regulatory, preclinical, labelling, clinical operations, medical writing, legal, medical affairs, and review and governance committees, as well as external Company partners, and regulatory authorities
- Mentor and develop GSO competencies for structured benefit-risk assessment, and other staff in the functional therapeutic area
- Patient preferences
- Semi-quantitative and fully quantitative methodologies for benefit-risk assessment
- Liaison to Epidemiology & Benefit-Risk team to train and promote design of TA-specific benefit-risk assessment strategy
- Internal development and benefit-risk committee preparations
- BRAC preparations
- Coordinator for GPV Pre-BRAC meetings
- Drive GPV team preparations for pre-BRAC meetings
- Ensure appropriate cross-functional input for pre-BRAC meetings
- DWG preparations
- Support GSS Head in DWG preparations by ensuring intra-GPV sharing of information and alignment of GPV position
