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 approvals.
- Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines, with experience in interacting with regulatory authorities.
- Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and regions.
- Strategic mindset with the ability to anticipate challenges, identify opportunities, and develop innovative solutions to achieve regulatory objectives.
Competencies
- Demonstrated technical proficiency and deep understanding of drug development processes, including familiarity with relevant scientific and medical concepts, regulatory requirements, and industry standards.
- Knowledge of regulatory requirements and guidelines governing drug development processes, including FDA regulations, ICH guidelines, and GCP standards, to ensure compliance throughout the project lifecycle.
- Proficiency in project management methodologies, tools, and techniques to plan, execute, and monitor drug development projects from initiation to completion as recognized by the Project Management Institute (PMI).
- Ability to lead cross-functional teams, inspire collaboration, and drive project teams toward common goals while demonstrating strategic vision and decision-making skills.
- Proven ability to effectively interface and collaborate with multicultural development teams and management, demonstrating adaptability, cultural sensitivity, and strong communication skills to foster cohesion and drive successful project outcomes across diverse cultural backgrounds.
- Strong verbal and written communication skills to effectively convey project status, issues, and recommendations to stakeholders at all levels of the organization, including executive management.
- Capacity to think strategically and align project objectives with organizational goals, ensuring that drug development projects contribute to the company's overall success.
- Aptitude for identifying, analyzing, and solving complex problems that may arise during the course of drug development projects, including risk management and mitigation strategies.
- Ability to build and manage high-performing project teams, including providing direction, coaching, and support to team members to maximize their potential and achieve project objectives.
- Skill in managing relationships with internal and external stakeholders, including clinical teams, regulatory agencies, vendors, and partners, to ensure alignment and collaboration throughout the project lifecycle.
- Proficiency in resource allocation, budget management, and forecasting to ensure optimal utilization of resources and adherence to project timelines and budgets.
- Ability to adapt to changing project requirements, priorities, and environments, while maintaining focus on project objectives and delivering results in dynamic and fast-paced settings.
- Commitment to continuous learning and improvement, including staying abreast of industry trends, best practices, and emerging technologies to enhance project management capabilities and drive operational excellence.
- Upholding ethical standards and integrity in all aspects of project management, including adherence to regulatory requirements, data integrity, and patient safety.
- Possess strong presentation skills with the capability to tailor presentations to diverse audiences, ensuring clear and impactful communication of complex information and ideas.
Other Requirements
- This position has significant managerial and decision-making authority.
- Ability and willingness to travel approximately 25% of the year both domestically and internationally
- Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month
ESSENTIAL PHYSICAL REQUIREMENTS
- Ability to articulate clearly and conduct verbal presentations with large and small audiences.
- Ability to travel via automobile and/or airplane.
- Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
- Ability to operate a computer keyboard and telephone.
- Ability to sit for extended periods of time – up to four (4) hours at a time.
- Ability to lift, tug, pull up to fifteen (15) pounds.
To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.
DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.
