Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Program Manager in our Cambridge office.
Provides project management and leadership skills to project team in the successful delivery of early to late-phase drug development programs. Direct operational execution of asset s clinical studies working closing with CRO partner and project team.
- 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 project leadership team and influencing decision-making, monitoring slippage and developing strategies to get back on plan.
- The Program Manager works closely together with the project leadership team, to ensure that the asset strategy is integrated into an operational plan.
- Participates in process improvement initiatives and takes on, as needed, non-project responsibilities, which can include project management processes and systems.
- Identify and drive innovative process improvements with significant organizational impact
- Oversight of clinicial trial Strategic Partners and other vendors to meet Takeda s ICH-GCP obligations and business objectives. The clinical program may be high complexitiy, or high risk, e.g. multiple indications, data monitoring committees and/or endpoint review committees, interim analyses, requiring coordination of multiple vendors, or other special assignments.
- Leads the project planning efforts of the project team in defining and implementation of the asset strategy framework as well as the operational plan, execution strategies & critical paths with the team.
- Contribute to project strategy and resource priorities that align with the business objectives.
- Addresses and resolves project challenges, keeping project leadership informed of critical considerations (e.g., resources, performance concerns).
- Establishes, communicates and executes plans resulting in achievement of project goals
- Manages the creation of project strategies and supports project leadership team in presenting these strategies to key stakeholders and decision makers.
- Adjusts project strategy and priorities in response to changes in strategic direction.
- Provides direction and obtains buy-in of all team members to Integrated asset strategy
- Identifies ways to accelerate the project execution where possible while maintaining high quality standards.
- Develops strong logistical skills to manage activities across functions and regions
- As a member of project team, the PM will attend and facilitate project team meetings. Ensure agendas are appropriate to enable key discussions and decisions within the team.
- Contributes to the leadership and management of the project plan execution and holds to the highest standards for operational excellence in drug development and life cycle management.
- Proactively identifies potential issues or obstacles and achieves resolution or plans contingencies and follows issues through to resolution, ensuring that all project team issues arrive at a singular conclusion or recommendations
- Provides financial oversight for project team budgets in early to late-phase drug development and/or life cycle management projects (including on-market/established products). Includes consolidation, vetting and prioritization of project team spending risks and opportunities.
- Manages program contracts and confidentiality agreements
- Leads the project risk management process in the team and generates the project risk register for assigned compounds. Independently resolves complex issues and competing priorities that may impact achievement of goals, and creates mitigation plans and drives to resolution.
- Works closely with the project team to balance operational execution with R&D and commercial strategy.
- Manages project status reporting including scheduled as well as ad-hoc updates.
- Participates in portfolio analysis process to ensure accurate information, timelines, and budgets are completed to support project recommendations.
- Generates collaboration, cooperation and communication across functions and between regional representatives in the team ensuring that team goals are achieved.
- Manage the overall operational execution of project s clinical trial program in collaboration with the appointed CRO
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
- Bachelor s Degree science or business-related field
- Advanced degree in science or business is preferred
- Knowledge of pharmaceutical industry and experience in Clinical Research, Regulatory, or other drug development related function. Clinical trial management, including oncology trial, experience preferred
- Demonstrated previous experience as a project manager leading drug development projects in a multi-disciplinary, global environment at various drug development cycles (e.g. early. Ph2, or LCM)
- Proven leadership skills and strategic problem-solving ability
Knowledge and Skills
- Project leadership and management skills are required
- Knowledge of global drug development, and the roles of contributory functions (e.g., QA, CMC, Regulatory, Clinical, Clinical Operations)
- Therapeutic area expertise is desirable
- 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
- Flexibility and tolerance and diplomacy to best manage change and differing opinions
- Strong communications skills written and verbal
- Management of multiple tasks of varied complexity simultaneously
- Excellent organizational skills
- Negotiation and strong persuasive abilities
- Presentation skills create and deliver presentations with appropriate messaging and focused recommendations
- Microsoft Project Professional, Excel, PowerPoint & Word
- Fluent in English
- Project Management Professional certification with PMI would be desirable but not required
- May work on the computer for several hours at a time
- May travel to US, EU, and Japan offices and other meeting locations including .international offices, strategic partner office, health authority locations, and therapeutic area meetings internationally
- Approximately 25% travel is required.
- 4 to 6 years of pharmaceutical industry experience. Previous drug development experience is preferred (e.g. Clinical Research, Regulatory, CMC, or BDM or other development related function), clinical research organization, clinical operations study management
- 3 to 5 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment which may include external partners
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.