Please note that the requirements specified in this posting are the basic qualifications required for the Sr. SPM Manager position; however, job title will be dependent on the candidate's level of experience in those requirements.
The Senior Project Manager provides project leadership to global, cross- functional teams in the successful delivery of early to mid-phase drug development projects or sub projects within a major development program. These responsibilities include leadership of the team in predicting and planning solutions to achieve successful operational execution; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making on projects. The Senior Project Manager will have a high level of interaction with the Clinical Science Lead to ensure that the scientific strategy is clearly integrated into operational plan.
- Lead the project planning efforts of the Regional Development Team (RDT) for the US and EU in defining and implementation of the project strategy and operational plan by managing the creation of the operational plan and formulating the project scope, project plan, execution strategies & critical paths with the RDT and the TGRD executive team.
- Identify and drive project and resource priorities that align with the business objectives and establishes, communicates and executes plans that drive toward goal achievement.
- Guide and manage the creation of project strategies and present these strategies to senior management.
- Provides clear direction and obtains buy-in of all team members to Integrated global development plan commitments
- Identify ways to accelerate the project execution where possible while maintaining high quality standards.
- Develops strong logistical skills to manage activities across functions and regions
- Manage the identification of potential issues or obstacles and achieves resolution or plans contingencies and follow issues through to resolution ensuring that all RDT issues arrive at a singular conclusion or recommendation.
- Responsible to lead and manage a drug development budget of $200MM to $500MM in early to mid-phase drug development projects with the potential annual sales impact of greater than $1.0Billion annually.
- Management responsibility for various programs includes matrix management of multi-disciplinary, cross-functional, global team members in the US, EU and in key contacts in Japan. Provide guidance for team members and review overall progress. Provides critical feedback to the individual members and/or the team member's manager when necessary.
- Generates collaboration, cooperation and communication across functions and between EU and US team members and ensure that the team achieves stated goals.
- Responsible for setting and managing expectations, highlighting and resolving issues, ensuring regular communications and managing internal and external activities. Facilitate the system to track and monitor program objectives/goals.
- Participate in the annual portfolio analysis process to ensure accurate information and timelines are completed to support project recommendations to Senior Management.
- Manage timely completion of clinical trial applications and end of Phase II meetings.
- The Senior Project Manager position will work closely with the Clinical Science Lead for a project to balance operational execution and clinical science strategy.
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor’s Degree science or business-related field
- Advanced degree in science or business is desired
- Minimum 7 years of drug development experience in Clinical Research, Regulatory, CMC, or BDM or development related function. Previous clinical research experience in Phase I-IV preferred.
- Minimum 6 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment
- Minimum of 3 years people management experience and/or proven leadership experience in managing a global, matrix team.
- Proven leadership skills and strategic problem-solving ability
- Demonstrated leadership skills managing matrix teams, influencing outcomes and key project decisions
- Proven ability to communicate and collaborate effectively with senior management
- Thorough knowledge of global drug development, QA, mfg ops, clinical & regulatory functions
Knowledge and Skills:
- Therapeutic area expertise is desirable
- Proactive ability to predict issues and problem solving abilities
- Ability to articulate and establish processes which impact cross-functionally
- Ability to drive decision-making within a cross-functional and cross-cultural, global team structure
- Issue identification and independent resolution
- Requires the flexibility and tolerance to best manage change and differing opinions with diplomacy and competence. Development timelines are very aggressive and multi-faceted; position can be stressful and demanding.
- Strong communications skills – written and verbal
- Management of multiple tasks of varied complexity simultaneously
- Excellent organizational skills
- Negotiation and strong persuasive abilities
- Diplomacy and positive influencing abilities
- Presentation skills – create and deliver presentations with appropriate messaging and focused recommendations
- Microsoft Project Professional, Excel, PowerPoint & Word
- May work on the computer for several hours at a time
Project Management Professional certification with PMI desired
May travel to London office and other meeting locations both in the US and internationally.
Approximately 25% travel is required.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 2 years ago