Responsible for the delivery of all Early Development (Phase 1) projects for key therapeutic areas within a Sponsor’s R&D organization. Activities include providing oversight and working closely the global Project Management team to proactively identify and solve potential barriers to successful delivery, communicating with functional management to ensure adequate and timely staffing of projects, development and tracking of KPIs, providing oversight of the Quality Management Plan, and the creation of innovative solutions designed to maximize efficiencies and productivity to achieve the Sponsor's short-term and the long-term objectives. Financial oversight and oversight of the program budgets This position will serve as the primary contact to the Sponsor for all Early Development programs, and will work closely with the PRA leaders of the later phase development teams.
Leadership Core Values:
People and communication are at the core of our philosophy. Our leaders regardless of experience are humble, genuine and never forget why we do what we do, which is the patients we reach. You will be a collaborative, engaging senior project management professional with an aptitude for driving change and performance as well as the ability to strategically and tactically evaluate and implement (possibly complex) Early Development programs and initiatives in full drug development. You will also be adept in working with various business leaders, building consensus around strategy across diverse regions. In addition, you must have strong leadership and people development skills in order to ensure consistent and seamless global Operations.
- Oversee the early development programs to enhance the achievement of a sponsor's short-term and the long-term strategy and objectives
- Lead effort on continuous evaluation of processes to identify inefficiencies and remediate issues to ensure and maintain company's competitive advantage
- Lead development of standardized solutions, core processes and metrics for all assigned programs
- Ensure regulatory compliance of all operations
- Build and maintain strong effective relationships with the Sponsor as well as interdepartmental staff throughout the company
- Provide appropriate early clinical/strategic input to company decisions
- Provide strategic input into proposals, crafting innovative new approaches and program designs
- Participate in client meetings and bid defenses providing operational and strategic input Coordinate and prepare clear and effective communications
- Attend and present at industry meetings and be active in professional societies as a representative of the Company
- BS degree in appropriate science field; advanced degree highly preferred
- Senior Management experience within Pharma R&D, Large CRO or Major Life Science Consulting firm
- Ten or more years in management positions in Clinical Development Operations or Clinical Project Management with a focus on Early development
- Proven track record of success in leadership role within a large CRO or Pharmaceutical organization
- Experienced in and knowledgeable about all key clinical operational functions (e.g. project management, clinical monitoring, data management processes, regulatory affairs and medical writing, etc.)
- Solid understanding of the drug development process
- Knowledge of FDA regulations GCPs/ICH
- Proven ability with high level influencing and negotiation skills
- Excellent communicator with ability to educate and influence decisions through clear written and verbal communications.