Global Program Safety Lead (all genders / full- or part-time)

Your role:

We have an exciting opportunity for a Global Program Safety Lead (GPSL).

• The GPSL is accountable for ensuring safety of the assigned products or product portfolio in close collaboration with the GPS Therapeutic Area Head. This role involves providing innovative, strategic input and scientific leadership to ensure comprehensiveness, accuracy, consistency, and overall integrity of the safety medical assessments for the assigned products or product portfolio. The position also entails establishing the medical safety strategic direction, including appropriate escalation within the company in case of new significant safety signals or safety issues.
• Proactive safety signal and benefit-risk management is essential, requiring close collaboration with other R&D functions. The GPSL will deliver safety expert contributions to the overall Clinical Development Plan, ensuring that it adequately addresses safety risks in collaboration with other R&D functions. Consistent high-quality representation of GPS on cross-functional teams, such as the Program Steering Teams, Clinical Teams, and Submission Teams, is crucial so that safety considerations reliably inform project decision-making and all clinical development safety requirements are met.
• The role includes direct oversight of the description, analysis, and interpretation of benefit-risk topics in documents owned by GPS, such as periodic safety reports, signal evaluation reports, benefit-risk strategy documents, and risk management plans. The GPSL will also deliver high-quality contributions to other product- and trial-related documents, including IMPD, IB, DCSI/CCSI, Briefing Books, PIP, concept sheets, and clinical trial protocols/reports.
• Furthermore, the position requires delivering senior expert contributions to benefit-risk evaluations and go/no-go decisions at critical development and life-cycle stages, including presentations to and interactions with senior leaders in appropriate governance and other settings, such as before the MSEB. Ensuring high-quality representation of scientific GPS content at meetings with external experts, such as SMCs/IDMC members, regulatory authority meetings, and interactions with external advisers or opinion leaders, is also part of the role.
• Additionally, collaboration with colleagues from partnership companies for co-development or co-marketing is expected. The GPSL will provide medical safety expertise and advice for Due Diligence activities and support strategically appropriate budget and resource planning for the short, mid, and long term.

Who you are:

• MD required (or international equivalent) with accredited residency
• Minimum of 10 years' experience in the pharmaceutical/biotechnology industry with at least 5-6 years in Global Patient Safety, especially analysis & interpretation based on data, science, and the disease being studied; profound experience in drug development (pharmaceuticals, biotech, CRO)
• Comprehensive mastery of global regulatory requirements for drug safety and pharmacovigilance
• Exceptional data analysis capabilities
• Excellent proficiency in signal detection and evaluation
• Excellent medical judgment in safety decision-making
• Profound understanding of continuous Benefit Risk Assessment
• Proven matrix management experience incl. strong influence and persuasion skills in an international environment
• Excellent knowledge of product development process and experience of cross-functional teamwork
• Strong, mature project leadership and influencing skills
• Strong team player and excellent networking skills
• Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets
• Excellent communication skills in English, specifically in written and oral presentations

We also consider Switzerland as a possible location.

Department: HC-RD-RSAI N&I Innovation

Job Evaluation: AT-Level 4 (Expert)