US Development Head (SVP/EVP)
Job Title: US Development Head (SVP/EVP)
Report to: CMO
- Lead and manage the Clinical, PV, PMO and RA, leveraging strong process and knowledge to drive team deliverables.
- Manage the day-to-day R&D department in US, overseeing planning and progress across the portfolio of programs from early development to regulatory filing
- Create, modify and support the short- and long-term Onco products clinical strategies based on the company’s business objectives
- Play a key leadership role in the development and improvement of business processes, tools and templates relevant to US clinical, cross-functional product development, and regulatory filing
- Develop and drive continuous improvements in US clinical, establish KPIs/metrics, and implement US clinical best practices
- Apply US clinical expertise, methodologies and standards to all programs, directly and through direct reports
- Facilitate team and working group meetings, ensuring meetings results-driven and positive team dynamics
- Collaborate with other clinical colleagues on developing and improving R&D and Arena business processes and performance as needed
- MD and Ph.D preferably with a background in clinical oncology or regulatory professionalism. PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge.
- At least 15 years of relevant experience, with excellent skills & knowledge with a whole/intense view of drug development and regulatory approval.
- Experience managing a diverse portfolio of global programs at various phases in the Oncology drug development lifecycle from early development through regulatory filing
- Advanced understanding of program management and associated deliverables, tools and expectations
- Effective written and verbal communication skills and an ability to inspire and influence at all levels
- Excellent oral and written English.