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Director, Project Management – Clinical Drug Development

@Orchard LLC has been retained by Taiho Oncology to lead a search for a Director of Project Management to oversee multiple Oncology-related Clinical Product Development initiatives. As the Director, Project Management, you will be the lynchpin connecting the various stakeholders and functional leaders throughout the trial from initial Phase One through to post-marketing of an approved drug. This is strategic versus operational management role, requiring great vision, organizational skills, and superior communication skills. You will be working on global trials, interfacing with international colleagues, in particular from Japan, prior experience of this nature will be strongly preferred. Success in this role is defined as the smooth execution of the trial through all phases and into commercialization, working with leaders across Taiho and its parent company. This is an opportunity to really make an impact and own the process of bringing life-saving medicines to the market.

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About our client;

Looking for a chance to make a real difference in the oncology space? Taiho Oncology (TOI) is on a mission: to improve the lives of cancer patients, their families, and caregivers. Our “People First” approach means we also value our employees, who work relentlessly to help us execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of our patients, our partners, and each other. Together, we’re working to discover and develop innovative cancer treatments that address unmet patient needs and apply the science behind them in novel ways. As the field of cancer treatment evolves, we evolve with it.

Advanced technology, dedicated investigators, and incomparable facilities: these vast resources empower us to redefine the way the world treats cancer.

It’s our work, our passion, and our legacy. If the prospect of being part of this sounds exciting, we invite you to join us.

About the role;

The Director, Project Management provides project leadership to global, cross-functional teams in all phase drug development projects or sub-projects designed and coordinated to achieve the organization’s strategy.  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 leadership and influencing decision-making on projects.

The Director, Project Management will have a high level of interaction with Taiho Oncology, Inc., (TOI) and Global Senior Leadership to ensure that the scientific strategy is clearly integrated into operational plans.

As the Director you will; 

  • Report to the VP, Project Planning & Management, and direct the project planning efforts for assigned global development programs. This includes; Defining and implementation of the project strategy and operational plan. Creating the operational plan.   Formulating the project scope, project plan, & critical paths in conjunction with the Project Team and cross-functional leadership.
  • Maintain the integrity of all global project deliverables and manage project delivery on time and on budget.
  • Identify and drive project and resource priorities to align with the business objectives.
  • Establish, communicate, and execute plans that drive toward goal achievement.
  • Provide clear direction and obtain the buy-in of all team members to Integrated global development plan commitments.
  • Direct the identification and escalation of potential issues/risks or obstacles and achieves resolution independently.
  • Plan contingencies and follow issues through to resolution ensuring that all issues arrive at a singular conclusion or recommendation with limited guidance from Senior Leadership.
  • Oversee and manage a drug development budget of varying size and scope in all phases of drug development projects.
  • Generate collaboration, cooperation, and communication across functions and between Japanese, EU, and US team members and ensure that the team achieves stated goals.
  • Facilitate the system to track and monitor program objectives/goals.
  • Participate in the quarterly portfolio analysis process to ensure accurate information and timelines are completed to support project recommendations to Senior Management.
  • Work with Regulatory Affairs, project management, and project team to effectively manage timely completion of regulatory documents including IND, FDA meeting background packages, NDA/sNDA, etc.

Your background will include; 

  • A bachelor’s degree in science or math. A master’s degree and or project management certification is preferred.
  • At least 7 years of drug development experience in Clinical Research, Regulatory, CMC, or BDM or development related function. Previous clinical development experience in Phase I-IV oncology projects preferred.
  • A minimum of 5 years of experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment.
  • Demonstrated people management experience, managing a global, matrix team, 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.

If your experience and interests align with this role, and you want to align your career with a stable and growing firm with an excellent pipeline of products within Oncology, then we need to hear from you. Please apply.

Established in 2010, @Orchard has an exceptional reputation, providing staffing solutions to time-sensitive, talent scarcity issues to deliver better talent management ROI.  Our specialty lies in the critical area of program talent acquisition and resource management, not in one narrow skillset, but across many areas of technical and functional delivery. To learn more about our other exciting opportunities, visit our Jobs Page at www.atorchard.com.


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