Job Description:
As a member of the Project Management team within Development, the incumbent partners with Team Leaders and works in close collaboration with Development team members, sub-teams, working groups, and Franchise Team members (as needed) to advance Development programs and projects.
Job Responsibilities:
- Works in partnership with team leaders and cross-functional team members to coordinate, influence and manage development, approval, and seamless execution of the Clinical development strategy.
- Provides project management leadership and support to the Development team, sub-teams, working groups, and Franchise Teams (as needed):
- Partners with team leader/s and team members to design, implement, and update Clinical Development Plans which define the scope of project team deliverables, ensuring Development Plans integrate molecule vision & strategy, with timing, scope, and resources. Contributes to the molecule Life Cycle Plans.
- Conducts timely, efficient, and action-oriented Development Project Team meetings and coordinates team operations, decision making, and communications.
- Directs complex project communications and ensures that all stakeholders are fully informed and knowledgeable of project activities and their status.
- Organizes preparation of high-quality documents for review by governance committees in collaboration with the project team and represents the Development Team at Governance meetings, when needed.
- Organizes the formation of Project Teams and guides transition of projects between development phases.
- Develops and maintains high-quality, integrated project plans aligned with overall program strategy, drives scenario planning, and ensures timelines are on track.
- Facilitates the identification, management and communication of key program risks and their associated mitigation plans.
- Partners with team leaders and team members to proactively address project issues which pose a challenge to achieving goals, develops and implements plans to resolve such issues, and executes corrective actions.
- Provides updated project reports and documents to support portfolio planning.
- Builds and leverages relationships and networks to enhance team dynamics; proactively identifying opportunities and removing obstacles to drive business results.
- Works with internal finance, team leaders, and team members on approval of study budget and ensures timely communication and approval of the budget changes by governance.
- Develops and implements stage appropriate and value-added processes, best practices and tools (e.g., integrated cross-functional timelines, governance, core & sub team processes) to increase efficiency and consistency.
- Follows company and compliance policies and practices.
Qualifications:
- BS/BA degree in a related discipline and a minimum of eleven years of related experience; or,
- MS/MA degree in a related discipline and a minimum of nine years of related experience; or,
- PhD/PharmD degree in a related discipline and a minimum of five years of related experience; or,
- Equivalent combination of education and experience.
- PMP (Project Management Professional) or other PM certification or equivalent a plus.
- In-depth knowledge of the drug development process and deep understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management.
- Expertise in developing and managing project scope, deliverables, risks and resource requirements.
- Experience leading and facilitating project team meetings, cross-functional communication and decision making, and ensuring ongoing alignment with internal/external stakeholders.
Skills:
- Proactive and strategic thinker with strong facilitation, problem-solving, and issue resolution skills.
- Excellent analytical skills with an ability to understand and present complex scientific and business information in a clear and concise manner.
- Outstanding verbal and written communications skills with the ability to effectively interact with all levels within the company.
- Ability to lead without authority, influence and motivate teams.
- Highly collaborative with outstanding relationship management skills and high emotional intelligence. Ability to create an inclusive environment and establish high-performing teams.
- Ability to help teams anticipate, plan, and adapt to an evolving environment.
- Advanced knowledge and skill with Microsoft Office applications and other reporting and tracking tools.
- Must be self-motivated and able to work under minimal and at times no supervision.
CA: Clinical Development/Regulatory PM (236963)
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