Senior Asset Quality Lead responsible for driving GCP quality and oversight for clinical assets at Pfizer. Ensuring quality risk management, inspection readiness, and regulatory compliance across asset teams.
About the role
- Director of Research & Development at Novartis translating insights into actionable strategies for R&D pipeline prioritization and execution. Influencing high-level decisions to bring effective medicines to patients.
Responsibilities
- Partner with R&D project teams (BPTs/GPTs) and DU/DA leadership from project start to approval to support tollgate and update preparation for strategic decisions at key governance boards and foster connection and exchange of Best Practice between BPTs and GPTs to enable drug discovery and development acceleration.
- Enable R&D leadership and key governance boards to make strategic decisions by bringing independent internal, external, competitor, and industry perspectives on assets, programs, and events with clear, actionable recommendations.
- Lead rigorous program/project feasibility assessments across key dimensions (science/preclinical, clinical, safety, regulatory, technical, clinical execution).
- Provide independent competitive insights and benchmarks on programs and trials and related events in assigned therapeutic area(s) and platform(s) incl implications for portfolio to the R&D organizations (leadership, teams, functions) to support project, TA and platform strategy.
- Work directly with project teams to help identify most relevant competitors and integrate insights into project strategies.
- Lead and/or support selected cross-functional, high-visibility initiatives/projects and deliver actionable insights on R&D pipeline strategy and performance (e.g., cross-portfolio reviews, peer pharma analyses, platform strategy, trial execution).
- Create disease area overviews and asset insights in the dedicated TA to inform mechanism-of-action strategy, competitive positioning, expansion opportunities, incl. learnings and watch-outs for the programs.
Requirements
- Graduate life sciences degree (Master’s or equivalent) required; PhD or equivalent preferred.
- Additional business degree (MBA) or equivalent business experience desirable.
- Minimum 10+ years in the pharmaceutical/biotech industry; experience in areas of either CI/Brand Management/Analytics/Value and Access with a leading pharmaceutical/ solution provider or experience in Pharma R&D.; experience in both fields are an advantage.
- Track record of operational excellence and the ability to synthesize complex data into succinct, actionable insights for senior audiences and to translate analytic skill into strategy.
- Deep understanding of R&D and the global competitive environment as well as knowledge of assigned disease area gained through roles in respective environment.
- Proven strong leadership in a cross-functional matrix and the ability to influence without direct authority and establish effective partnerships.
- Proven ability to deliver under tight timelines and with demanding stakeholders.
- Clear, audience-tailored communication style suited for senior management; ability to develop a persuasive and credible presentation style at all levels of organization.
- Extensive cross-functional work experience in international multidisciplinary teams in drug development or consultancy with ideally exposure to the full R&D lifecycle.
- Strong process/project management skills; with experience in remote relationships (on-shore / off-shore capability delivery).
- Fluent English (oral and written).
Benefits
- Accessibility and accommodation support
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