Senior Project Manager, Regulatory Science – Acerta
Acerta Pharma is a leader in the field of covalent binding technology and is applying this technology to create novel, highly selective therapies for cancer. In February 2016, AstraZeneca acquired a majority share of Acerta Pharma via a USD $4 billion investment and is a committed partner to the development of these innovative drug candidates.
Acalabrutinib is Acerta's lead program which was developed based on our discovery efforts. It is an investigational covalent Bruton tyrosine kinase (BTK) inhibitor currently under investigation in multiple Phase 3 clinical trials. The clinical program includes over 20 trials in hematologic malignancies and solid tumors. Over 1,800 patients have participated in these trials to date.
The Senior Project Manager, Regulatory Science serves as a strategic partner to the Global Regulatory Leaders (GRLs) and/or Filing Team Leaders, work with the the cross-functional global filing team members to define regulatory filing strategy, convert the strategy into an executable plan, and facilitate flawless execution of the plan to enable successful global filings and Health Authority interactions.
* Applies project management methodology and disciplines to improve the efficiency and effectiveness of the global filing team and contributes to the efforts of building templates, tools and processes to optimize filing team performance.
* Provides appropriate level of Project Management service, and tactical leadership to multiple global filing teams based on the agreed scope of work and business need; takes accountability for all project management aspects and works effectively and closely with the GRL or Filing Team Leader.
* Drives creation and updates of a high quality filing timeline using MS Project with clearly defined activities, interdependencies, duration, task owners and planning assumptions; collaborates closely with the GRL and team members to coordinate, prioritize and aligns team's activity in support of the project plan and ensure a structured approach to activity execution, and the efficient utilization of resources.
* Actively tracks the progress of the deliverables, and partners with GRL to create reports and trackers to ensure clear and transparent communication to key stakeholders.
* Works closely with team to identify and manage the activities which are on critical path and the critical activities that have the potential to become critical path activities; identifies the potential risks that could impact the timeline and PRS of a filing, and work with team to define a mitigation plan.
* Effectively facilitates filing team meetings with high quality meeting agenda and minutes.
* Maintains an action item tracking log, drives the completion of the action items, and documents the resolution of the action items.
* Facilitates team communication, monitors the activities of the project team to ensure constructive team dynamics, effective communication and progress in conformance with project scope and timelines.
* Maintains proper online documentations of filing related project documents.
* Assists GRL on preparation, organizing and conducting lessons learned sessions post filing.
* Through support of the projects, identifies near-term improvement opportunities to leverage and/or enhance PDR PMO's project management knowledge, process, tools, and templates to potentially increase efficiencies, accelerated activities and standardize processes.
Requirements:
Required:
* Bachelor's degree in a scientific discipline preferred, proficiency with common project management tools including MS Project is required, and PMP (Project Management certification) or equivalent.
* Significant years of project management experience in cross-functional drug development projects in pharmaceutical/biotech industry is required; experience supporting a global team.
* Strong project management and team facilitation skills.
* Proficiency with project management tools such as MS Project.
* Demonstrated ability to collaborate and negotiate business solutions in a complex and fast paced matrix global environment; strong written and oral communication skills with a proven ability to communicate effectively at all levels in the organization.
Preferred:
* Team player with strong interpersonal skills, paired with strong partnering and performance consulting skills and ability to work independently and as part of a team.
* Strong planning and organizational skills; able to multi-tasking, prioritize and organize high volume workflow; ensure attention to details and accuracy within required timeframe; have good judgment and able to balance efforts and quality of work and high degree of customer focused sensitivity.
Next Steps — Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
