The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients and health care providers expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. The Global Program Manager in Plasma-Derived Therapies Business Unit will have the ability to create and define the future vision and operating model for the team. There will be two main drivers of innovation in the newly-formed PDT R&D group:
- Translational Pharmaceutical Sciences: This innovation engine will practice rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield. It will combine translational research with pharmaceutical sciences and device, and will receive inputs from and into clinical research and manufacturing sciences.
- Precision Medicine: This innovation engine will focus on developing comprehensive, value-oriented health care delivery packages around drug products, targeted to maximize benefit and reduce risk to precise patient populations. In the process, this engine will drive innovation by practicing patient-centric R&D.
The Senior Director, PDT R&D Global Program Management Lead will provide global program management and matrixed leadership to global, cross-functional, cross-divisional teams to drive development and deliver results in early to late-phase pipeline or marketed assets.
- Responsibilities include providing strategic direction and translating the cross-divisional, integrated Global Product Team (GPT) strategy into an efficiently executable plan; predicting and planning solutions to achieve program goals and objectives; driving clarity and removing barriers to ensure team success; interfacing with management and influencing decision-making, proactive management and mitigation of development risks, and ensuring appropriate communication and interface with internal governance.
- The Global Program Management Lead works closely with the Global Program Leader (GPL), as well as other Chief Medical Scientific Office (CMSO) and Commercial functions to ensure that the scientific and commercial strategies are incorporated into the asset strategy and integrated development plan.
- This role may also lead key initiatives that have cross-functional or cross-divisional impact that are critical to the objectives of the business unit, CMSO and/or global business objectives.
- Identifies and drives innovative process improvements with significant organizational impact and manages, as needed, non-project responsibilities, which can include processes and system optimizations.
- Partners with GPL to lead GPT or joint Program Team (for partnered Alliance programs) to develop and maintain the asset strategy and integrated development plan in conjuction with TAU and commercial strategy, lifecycle management requirements, and evidence generation/publication needs.
- Accountable to maintain the integrated program level plan, identifying and ensuring delivery of critical path activities to progress asset development.
- Drives clarity with GPT and other relevant stakeholders to communicate asset strategic imperatives to ensure appropriate prioritization and execution.
- Identifies ways to optimize program execution without compromise to patients or compliance.
- Proactively identifies resource requirements necessary to progress asset development in alignment with BU or enterprise business objectives.
Program Operational Excellence
- Ensures asset strategy and integrated development plan have a patient-centric focus, incorporates innovative approaches that are meaningful to patients, HCPs, regulators & payers, and adhere to the highest standards of operational excellence in drug development and life cycle management.
- Manages the strategic GPT forum to ensure progress of asset development. This includes establishing meeting agendas, facilitating team discussions, and driving to clear and timely team actions and decisions.
- Partners with the GPL to provide financial oversight of the program including global, cross-divisional budgets. Includes consolidation, vetting and prioritization of GPT spending to deliver critical path activities.
- Proactively addresses and removes barriers to program progress, keeping leadership informed of critical considerations (e.g., resources, performance).
- Proactively identify potential issues or obstacles and achieves resolution or plans contingencies. Follow issues through to resolution ensuring that all key stakeholders are informed of outcomes and program implications.
- Provides clarity and direction in urgent or unexpected situations. Independently resolves complex issues and competing priorities that may impact achievement of goals, creates mitigation plans and drives to resolution.
Communication and Reporting
- Manages scheduled and ad-hoc program status reporting, citing progress to program goals/KPIs, proactively identifying risk with planned mitigation(s), and providing rationale for timeline and budget variances.
- Participate in annual portfolio analyses to communicate program development progress, opportunities, and risks to Senior & Executive Management.
- Responsible for leading preparation efforts for governance engagement to support and drive asset objectives and deliverables.
- Facilitates relevant communications to appropriate cross-regional, cross-functional, cross-divisional and Alliance partners
- Provides direction and mentors junior colleagues to work strategically and drive results; identifies opportunities for to demonstrate their abilities; uses effective coaching techniques to refocus energy and address barriers to success; leads by example
- May support Business Development in-licensing activities to ensure appropriate technical assessment, including development costs and timelines, to support the business case of potential in-licensed compounds.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Minimum of a Bachelor s Degree science related field
- Advanced degree in science or business is preferred
- 20+ years of pharmaceutical industry experience with significant experience within related functions (e.g. Clinical Science, Clinical Operations, Research, Regulatory, CMC, Marketing)
- 15+ years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment
- Minimum of 10 years people management experience and/or proven leadership experience in managing a global, matrix team.
- Detailed and in-depth knowledge of pharmaceutical industry and drug development experience in all phases of development.
- Proven leadership skills managing matrix teams, influencing outcomes and key project decisions, and strategic problem-solving ability
- Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management
- Substantial experience in intercultural cooperation
Knowledge and Skills
- Matrix program leadership and management skills are required
- Proactive risk management with ability to propose solutions and deliver appropriate mitigation plan
- Ability to communicate (written and verbal) with impact to provide appropriate context, articulate views, drive clarity, and address barriers to progress program development
- Ability to drive decision-making within a cross-functional and cross-cultural, global team structure
- Flexibility, tolerance and diplomacy to best manage change and differing opinions
- Ability to work in a virtual setting/across time-zones, i.e., making effective use of communication tools (WebEx, TelePresence, telephone and video conferencing, etc.)
- Ability to inspire and motivate in a matrix and global, cross-geographical team
- A solid business background as well as excellent commercial understanding
- Highly effective presentation skills
- Experience with Microsoft Project Professional, SharePoint, Excel, PowerPoint & Word
- Fluent in English
- May travel to the US, EU and Japan offices and other international locations.
- Approximately 15% travel is required.
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