|Title:||VP, Team Leader|
|Department:||Research and Development|
VP, Team Leader
The VP, Team Leader will be responsible for leading and managing novel drug development project(s) and teams to successful development, NDA/BLA preparation, submission and product launch/commercialization. Working closely with all levels of leadership to determine program strategies, the Team Leader will set strategies and implement operating plans for the organization, and will be responsible for the overall project budget.
This role will provide leadership and matrix management for one or more development teams; developing program strategy and modifying program strategy in response to changing business needs; provide input into assessment of program team members; lead communicator and presenter at key external business meetings with stakeholders (e.g. Regulatory authorities, Regulatory advisory meetings). Ensure quality, timelines and budget goals are met.
- Communication and engagement with key stakeholders and Senior Management to ensure transparency and alignment on project plans
- Partnership with Program Management to ensure consistent, high quality input from the team, and engagement with PM in exploring opportunities to enhance speed and/or project value
- Overall development strategy and clinical development plan, resource, and budget planning
- Assessment of BD opportunities which could impact on Development programs, monitoring external scientific information and competitor activity related to Development programs and modifying program strategy as appropriate
- Tracking progress against project goals and composing monthly reports for Senior Management, outlining key strategic events for projects. These documents contain program milestones, strategic imperatives, and financial information regarding projects.
- Responsibilities may include post-marketing commitments and life cycle management initiatives.
- Clinical representative at key external meetings (e.g. with regulatory authorities) and may present at regulatory advisory meetings
- Key point of contact for external key opinion leaders
- Ph.D. or M.D. with 10+ years of experience managing Clinical Development projects in pharmaceutical or biotech company. Experience in small and large pharma and in different business models preferred
- Development experience with monoclonal antibodies highly preferred
- Strong knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe, experience in global drug development
- Extensive experience of team leadership in a matrix management environment
- Strong interpersonal and influencing skills
- Track record of success in applying new, innovative approaches to drug development
- Experience with drugs at all stages of development, including commercialization, and experience presenting data to regulatory agencies and advisory committees
- Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
- Capable of managing multiple priorities simultaneously
- Highly developed negotiation skills
- A strong focus toward creativity, independent thinking and results orientation is required