Shire Jobs

The Senior Director of Drug Development Project Management is accountable for providing project management and drug development expertise to global project teams within the rare diseases franchise. This role involves strategic development and execution of integrated product development plans to ensure alignment with organizational goals and objectives. Collaborating with cross-functional teams, the Senior Director oversees the planning, execution, and monitoring of drug development programs, ensuring they are completed on time, within budget, and in compliance with regulatory requirements.
Furthermore, the Senior Director represents Shionogi Inc. in global workstreams to ensure consistency across regions. This entails playing a pivotal role in stakeholder communication, risk management, and relationship management with internal and external partners. Additionally, this is responsible for driving the integration of key internal and external functions necessary for successful delivery of development projects.
Moreover, this role is accountable for establishing, managing, and leading High-Performing Teams (HPT) within the organization, fostering a culture of excellence and collaboration to achieve project objectives.
RESPONSIBILITIES
Provide strategic direction and leadership in rare disease drug development project management, aligning projects with organizational goals and objectives.
Develop comprehensive project plans, timelines, and budgets for drug development programs, overseeing their execution and ensuring adherence to timelines and budget constraints.
Identify potential risks to project timelines, budgets, and objectives, and develop and implement mitigation strategies to address them.
Manage resources effectively across projects, ensuring optimal allocation of personnel, budget, and other resources to achieve project goals.
Communicate project updates, progress, and challenges to stakeholders, including senior management, ensuring transparency and alignment with organizational objectives.
Ensure compliance with regulatory requirements, quality standards, and best practices in drug development project management.
Monitor and evaluate project performance against key metrics and milestones, identifying areas for improvement and implementing corrective actions as necessary.
Oversee relationships with external vendors, including contract research organizations (CROs) and other service providers, to ensure timely and quality delivery of outsourced activities.
Drive continuous improvement initiatives in project management processes, tools, and methodologies to enhance efficiency and effectiveness.
Develop and manage project budgets, tracking expenses and ensuring financial accountability throughout the project lifecycle.
Collaborate with cross-functional teams including research, clinical development, medical and regulatory affairs, and commercial teams to drive successful drug development programs.
Provide strategic guidance and decision support to senior management on project priorities, resource allocation, and risk management.
Represent the project management function in internal and external meetings, conferences, and forums, advocating for the needs and priorities of the project management team.
Act as the secretariat for key development-related meetings, including Clinical Development Leadership and departmental meetings for Clinical Operations and Medical Science, as well as future Protocol Review Committee and DSMB meetings.
Build and/or manage high-performing project teams, including providing direction, coaching, and support to team members to maximize their potential and achieve project objectives.
Develops working collaborations with rare disease organizations and patient advocacy groups and ensures Shionogi representation at national and international rare disease forums.
Other duties as assigned.
MINIMUM JOB REQUIREMENTS
Qualifications
Advanced degree in a relevant field such as life sciences, pharmaceutical sciences, project management, or a related discipline.
Minimum of 12 years of experience in drug development project management or related roles within the pharmaceutical, biotechnology, or healthcare industry.
Extensive experience in clinical development of treatments for rare diseases, ideally overseeing an asset from early development stages through to approval and commercialization.
Project Management Professional (PMP) certification required.
Demonstrated experience in leading cross-functional teams and managing complex drug development projects from initiation through to commercialization or regulatory approval.
Strong understanding of drug development processes, including clinical trial phases, regulatory requirements, and project management methodologies.
Proven track record of successfully delivering projects on time, within budget, and meeting quality standards.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
Experience in strategic planning, resource allocation, and budget management for drug development projects.
Proficiency in project management software and tools, as well as Microsoft Office Suite (e.g., Excel, PowerPoint, Word).
Knowledge of regulatory submissions and processes, including NDA submissions, FDA regulations, and ICH guidelines.
Leadership skills, including the ability to mentor and coach team members, drive change, and foster a culture of continuous improvement.
Proven track record of successful leadership and management of teams, with demonstrated ability to develop and execute regulatory strategies, drive regulatory submissions, and achieve regulatory...

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