MSI Pharma is working with one of the largest pharmaceutical companies on a Senior Director role on an initial long-term contract.
Responsibilities for this role include:
- Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
- Provide expert contribution to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy
- In collaboration with SSLs:
- Lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.g. CDP, IDCP), study reports, aggregate reports and high level regulatory documents
- Lead review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
- Lead the safety contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SSL
- Lead the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
- Lead risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
- Lead the strategy and review of safety assessments and drug safety reports for signals or issues ( inc, product quality) or in response to HA requests
- In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.
- Lead the development of scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve the submissions from a safety perspective
- Provide expert support to enable/facilitate the transition of appropriate drug candidates between EMS and LMMS
- Able to manage multiple and/or complex programs and coordinate the production of complex deliverables
- Provide experienced leadership to cross-functional safety teams
