Job Title: AD/Sr. Manager Program Management
Job Number: 33314
The AD/Senior Manager of Program Management in Clinical Development will provide assistance to the Clinical Development Team in all areas related to planning and achieving the organization's development objectives. This role is essential in supporting the team throughout the entire process, starting from Phase 1 clinical trials and continuing through regulatory filings, Ph 3/4
Working closely with the Program Management Lead, this role acts as the primary Project Manager for the Clinical Development team, overseeing various aspects of the clinical program. Responsibilities include creating and maintaining timelines, setting agendas, and supporting ad-hoc working groups to ensure successful project execution. Additionally, this position assists the Lead Program Manager with other program-related tasks as required.
The role contributes to the development of the Clinical Development Plan by collaborating with the lead program manager and other team members, taking into account project scope, milestones, and deliverable dates. They are responsible for constructing and managing a cross-functional timeline that outlines dependencies, milestones, deliverables, risks, and critical paths. The Project Manager also facilitates cross-functional reviews and ensures that clinical development functions adhere to the designated timelines for key deliverables and milestones.
In collaboration with the Clinical Development team leader and functional leads, the Project Manager supports and facilitates team meetings, striving for effective results and fostering positive team dynamics. This involves developing meeting agendas, prioritizing topics, issuing meeting minutes to summarize decisions and actions, and tracking the completion of action items with cross-functional leads.
The Project Manager also provides support to ad-hoc working groups that emerge based on the needs of the Program Team, ensuring that proposals and decisions are communicated back to the team. They facilitate communication flow and engage key stakeholders in important decisions and actions.
Furthermore, the Project Manager assists the Program Management Lead in coordinating and developing presentations for Program Review meetings or corporate presentations. They may also contribute to the organization of steering committee meetings or clinical advisory boards in collaboration with the Clinical Development department.
Financial support is provided by assisting Finance in generating budget forecasts aligned with the Clinical Development Plan.
Collaboration with team members is encouraged to foster a positive and productive team dynamic. The Project Manager actively participates in the development and implementation of key business processes, best practices, tools, metrics, status reports, and templates related to program management. They also coordinate and support Lessons Learned initiatives for the Program Team and other cross-functional teams as necessary.
The AD/Senior Manager should possess expertise in at least one functional area that directly contributes to the successful development of drugs in the later stages. They should hold a Bachelor's or Master's degree in a scientific or technical field, or have equivalent experience. A pharmaceutical/clinical development background of 6-8 years is required, with a minimum of 3-4 years of experience in project/program management within the industry or academia. Experience in Phase 2/3 clinical studies is highly preferred, and a focus on late-stage clinical development is desirable.
The candidate should have knowledge of the drug development process and a solid understanding of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP (Good Clinical Practice) governing the conduct of clinical development activities. Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint) is essential, and experience with Project Management Software (such as SmartSheet, MS Project, ThinkCell, and OfficeTimeline) is highly preferred.
Excellent interpersonal skills and effective verbal, written, and presentation abilities are required for this role. The Senior Manager should be a creative problem solver, capable of addressing issues promptly and independently. They should have a strong focus on achieving results, be highly collaborative in cross-functional settings, and take a proactive approach. Demonstrated ability to organize multiple priorities and projects is crucial.
This position is primarily based in an office environment, with occasional domestic and international travel, not exceeding 10% of working time, which may be necessary.
Compensation and Benefits:
Salary range: Sr. Manager $145,000-$160,000, AD $165,000-$185,000
Health Insurance (medical, dental, vision)
Short- and Long-Term Disability
Paid Time Off (PTO)
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