The overall responsibility will be to apply project management and leadership skills to programs through all stages of the candidate development process, including preclinical IND-enabling studies, Phase 1-3 clinical development studies, and agency submissions. The successful candidate will manage multi-disciplinary project teams and liaise with local and global team members to develop and monitor key milestones, manage day-to-day project activities, and facilitate communication throughout the organization.
Primary Duties and Responsibilities
Bachelor's Degree with a science major preferred.
- Provides project management expertise to the multi-disciplinary project teams and sub-teams, with a focus on optimal communication between all functional areas.
- Collaborates with project team leaders and senior management to develop and track detailed, aggressive and cost-effective project plans to ensure milestones and deliverables are met successfully.
- Identifies and communicates critical path activities along with any risks, issues or resource requirements pertaining to project plans/timelines and work with project team colleagues to develop appropriate solutions.
- Drives information flow and regularly communicates and reports on milestones, plans, status and decisions to the project team and management.
- Sets agendas, manages meetings, develops meeting minutes, documents project team activities and deliverables, and communicates key decisions/actions during team meetings.
- Prepares and maintains detailed Gantt charts and other documents to monitor/control resources and activities.
- Partners with Finance and functional lines to develop project budgets and tracks the financial status of key activities on a regular basis.
- Maintains up-to-date knowledge of scientific principles and theories in the gout and inflammation field, and possesses fundamental understanding of the competitive environment.
- Performs other project-related duties as agreed with management.
5+ years of drug development pharmaceutical/biotechnology experience, preferably in a project management-related role.
Experience in small molecule development and knowledge of IND and NDA submission process is preferred.
Proficiency in strategizing, planning, monitoring and problem solving.
Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing and influencing indirectly.
Flexibility to work in a fast-paced environment. Ability to manage multiple and diverse issues seamlessly.
Strong facilitation, organizational, analytical and time management skills.
Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project.
Ability to apply knowledge to new situations and drive consensus.
Effective communication skills and ability to articulate complex and broad concepts and translate into plans for action and constructive improvement.
Ability to “roll up your sleeves” and individually contribute results in a team-based environment.
Experience writing technical and management documents, reports and presentations.