Clinical Program Leader
One DNA Way South San Francisco, CA 94080
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- Through appropriate leadership, direction and operational expertise, lead the development and execution of operational strategies for multiple molecules/programs in Genentech?' s early development portfolio:? Represent Clinical Operations on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams)? Develop program timelines and budgets and manage variance? Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans? Lead the Clinical Operations team to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget? Develop and present operational plan to management review bodies? Identify program risks and develop and implement mitigation strategies for assigned programs? Define the resourcing and outsourcing strategy for early development programs? May participate in Business Development assessments? Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders? Partner with Business Management to identify strategic business needs to support the clinical programs? Partner with late-stage development leaders to ensure strategic alignment on the CDP Functional Management
- Demonstrated understanding, knowledge, and experience of drug development in a complex setting with particular focus on early development ? Demonstrated experience in various therapeutic areas ? Strong analytical and strategic agility skills ? Excellent planning and organizational skills ? High level of initiative and ability to work independently ? Exceptional leadership skills, including motivation and delegation ? Highly effective team player and exceptional interpersonal skills ? Strong financial acumen with experience managing clinical program budgets ?Proven ability to implement and manage a clinical program (i.e. a series compromising a clinical development plan) ? Ability to drive, encourage and support innovation ? Demonstrated ability to challenge established practices and concepts ? Highly effective verbal and written communication skills in English
- 10+ years experience of clinical and drug development, including 5+ years of clinical trial management experience and 2+ years of clinical program management experience
- Bachelors Degree or equivalent required (scientific or healthcare discipline preferred) Advanced degree preferred Working knowledge of international regulatory and ICH GCP guidelines