- Support developmental programs in Oncology, including both early and late stage development as required.
- Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibilities as appropriate.
- Supporting Therapeutic Lead
- Line management responsibilities for junior physicians and/or scientists
- Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs
- Expectation of Global Safety Lead (GSL) role for compound(s) both in development and marketed in close association with the Therapeutic Area Leader.
- Company -wide safety expert for his/her compound responsibilities.
- Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for own compounds with input for other compounds as needed.
- Serving in a leadership capacity for complex and strategically important programs
- Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc.
- Training and mentoring of Patient Safety Physicians and Specialists
- Perform activities required to serve as Global Patient Safety physician:
- Review and oversight of safety data, both non-clinical and clinical
- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
- Interactions with external experts and regulatory agencies and partner/co-development companies
- Review of safety data and participate in dose escalation decisions
- Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
- Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
- Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Qualified physician (License, e.g. GMC registered, preferred)
- Knowledge of principles of epidemiology and statistics.
- Critical thinking and analytical skills and ability to make high level decisions
- Excellent oral and written communication skills including ability to present to large internal/external groups
- Good level of computer literacy with Microsoft applications
Estimated 5-10 times per year including international travel
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