THE OPPORTUNITY:

The Associate Director Project Management will be responsible for project management activities related to clinical regulatory submissions and for Clinical Pharmacology and Quantitative Pharmacology (CPQP) deliverables.

Education, Qualifications, Skills and Experience:

• Minimum 10 years relevant experience in the biopharmaceutical industry which includes experience with late-stage clinical programs with increasing responsibility in project management and/or leading drug development team(s).
• Masters in science (MS) or Masters in Business Administration (MBA) and Project Management Professional (PMP) qualifications are highly preferred.
• Proven skillset in the use of project management tools.
• A proven track record of project delivery in submissions.
• Able to identify opportunities and synergies across projects.
• Takes ownership of own development and mentors more junior professionals to support their development.
• Has specialist knowledge in drug development.
• Leadership in solving problems to improve Organizational effectiveness
• Demonstrated experience and skills in Microsoft Word, Excel, PowerPoint, Outlook, Visio, MS Teams and OneNote.
• Excellent organizational, forward-planning, team working and stakeholder management skills with a strong attention to details.
• Professional and enthusiastic approach with ability to independently manage a diverse workload.
• Ability to respond to complex challenges quickly and efficiently with the flexibility to adapt to changing situations.
• Proficient in the English language.
• Excellent interpersonal, verbal and written communication skills (including negotiation and presentation skills). Strong ability to communicate clearly and concisely within a matrix environment.
• Ability to negotiate within project team and promote high performance.
• Demonstrates a composed, professional manner when dealing with issues, challenges conflicts and opportunities.
• Builds positive collaborative relationships with a variety of internal staff and outside contacts.
• Ability to multi-task effectively and prioritize workload with a sense of urgency in moving projects forward.
• Well organized with excellent time management.
• Working knowledge of Agile project management and software such as MS Project and/or Planisware.
• Must have proven record of high-quality independent work

IN THIS ROLE YOU WILL:

Submissions/Initiatives Project Management:

• Manage multidisciplinary CPQP submission teams for assigned ongoing, upcoming, and post-submissions. Provide high quality project management support to the teams with timeline creation and tracking of milestones. As required, additional responsibilities include meeting management (team agendas, minutes), risk mitigations, collecting lessons learned and facilitation of requests.
• Support CPQP in late-stage projects, regulatory filings, and creating/tracking of action logs, timelines for deliverables. Liaise with Regulatory Affairs and the broader Clinical Pharmacology team to align on strategy, plan for resources, and ensure timely delivery of global submissions.
• For ongoing and upcoming initiatives in CPQP, provide project management support to the teams with timeline creation and tracking of milestones.
• Provide support and share knowledge regarding project management with other team members.

Reporting:

• Provide projects status cycle and ad-hoc reporting to the global executive leaders.

Process Improvements and Development:

• Leadership in solving problems to improve organizational effectiveness
• Create and contribute to processes where little or none exist by working with the key stakeholders.
• Have awareness of company processes/standards and how these impact CPQP deliverables.
• Manage and coordinate creating of strategic presentation and materials.
• Collaborate with external partners in the field of Project Management and team development.
• Work within a matrix environment to communicate and identify/resolve issues that could have implications to the broader organization and stakeholders.
• Demonstrate influence and ability to communicate across many levels within a global organization.
• Clear and efficient communication with multiple stakeholders, as well as lead and facilitate meetings to address business issues, develop mitigation plans, and build consensus.
• Provide specialist administrative support and financial governance support to the CPQP department.
• Must be able to work independently on multiple tasks in a high paced environment, be dedicated and detail oriented.
• Strong organizational and analytical skills including priority setting and time management.

REQUIRED FOR THE ROLE:

Education, Qualifications, Skills and Experience:

• Minimum 10 years relevant experience in the biopharmaceutical industry which includes experience with late-stage clinical programs with increasing responsibility in project management and/or leading drug development team(s).
• Masters in science (MS) or Masters in Business Administration (MBA) and Project Management Professional (PMP) qualifications are highly preferred.
• Proven skillset in the use of project management tools.
• A proven track record of project delivery in submissions.
• Able to identify opportunities and synergies across projects.
• Takes ownership of own development and mentors more junior professionals to support their development.
• Has specialist knowledge in drug development.
• Leadership in solving problems to improve Organizational effectiveness
• Demonstrated experience and skills in Microsoft Word, Excel, PowerPoint, Outlook, Visio, MS Teams and OneNote.
• Excellent organizational, forward-planning, team working and stakeholder management skills with a strong attention to details.
• Professional and enthusiastic approach with ability to independently manage a diverse workload.
• Ability to respond to complex challenges quickly and efficiently with the flexibility to adapt to changing situations.
• Proficient in the English language.
• Excellent interpersonal, verbal and written communication skills (including negotiation and presentation skills). Strong ability to communicate clearly and concisely within a matrix environment.
• Ability to negotiate within project team and promote high performance.
• Demonstrates a composed, professional manner when dealing with issues, challenges conflicts and opportunities.
• Builds positive collaborative relationships with a variety of internal staff and outside contacts.
• Ability to multi-task effectively and prioritize workload with a sense of urgency in moving projects forward.
• Well organized with excellent time management.
• Working knowledge of Agile project management and software such as MS Project and/or Planisware.
• Must have proven record of high-quality independent work.