Leadership and matrix management of all aspects of the activities of multiple Development Program Teams, providing a strategic business perspective developing program strategy and modifying program strategy in response to changing business needs. Provide input into performance assessment of program team members. Line management and/or mentorship of less experienced Development Program team leaders or Clinical research staff. Lead communicator and presenter at all key external business meetings with stakeholders (e.g. regulatory authorities, Regulatory advisory committees, Payor meetings)
Communication and engagement with key stakeholders to ensure transparency on program status and alignment on project plans. Act as a key link between Clinical Development and Business Units, and contribute to the strategic thinking at the Therapeutic Area level. With the TA Head, define an overall strategy for program leadership, in addition to contributing to decisions related to balancing resources
Overall development strategy and plan
Coordination of budget for Development Program, addressing issues as they arise
Assessment of Business Development opportunities which could impact on Development Programs, monitoring external scientific information and competitor activity related to Development Program(s) and modifying program strategy as appropriate. Be the key link to external Key Opinion Leaders in area(s) of focus, and represent Shire HGT at external scientific meetings as necessary.
Responsible for tracking progress against goals and composing monthly reports for senior line management and HGT/Shire Leadership team outlining key strategic events for program(s). These documents contain program milestones, strategic imperatives, and financial information regarding programs.
Education & Experience Requirements
- M.D. with deep experience managing Clinical Development projects in pharmaceutical or biotech company. Experience in small and large pharma and in different business models preferred
- >8years experience in the pharmaceutical/biotechnology industry
- Experience of drug development in hematology or gene therapy would be preferred
- Strong knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe, experienced in global drug development
- Aware of changing trends in pharmaceutical drug development and experience in applying new approaches
- Extensive experience of team leadership in a matrix management environment
- Experience with drugs at all stages of Clinical Development and presenting data to regulatory agencies/Advisory Committees. Experience in taking drugs to market preferred
- Experience in modifying project plans and defining creative solutions to meet business needs.
- Troubleshooting and solving problems under very challenging timelines while maintaining standards of quality
- Experience as an effective mentor. Line management experiencepreferred.
- Strong publication record and experience with external Scientific Advisory Boards preferred.
Domestic and International travelrequired as necessary for face to face meetings with key stakeholders, meetings with external key stakeholders, and attendance at external scientific and business meetings related to area of focus. Must be prepared to present at large and small external meetings.
Req ID: R0017754