Director, Project Delivery - Global Project Management, Ophthalmology

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Overview

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Director, Project Delivery (DPD) is critical to the successful deployment of clinical project management as a function in the conduct of Biopharmaceutical-sponsored clinical trials globally. The DPD will work collaboratively with other GPM's and SGPM's to provide oversight, guidance, and leadership to the clinical project management group. The DPD may provide line management and oversight of the project managers across the biopharma portfolio of work, ensuring effective project leadership from development of the proposal to final contractual deliverables. The DPD will be client facing. The DPD will ensure the project managers are effectively leading project delivery in agreement with the contracted project timeline and budget. The DPD ensures the Project Managers are directing project delivery by driving team and financial efficiency, work product quality, and are engaging effectively with clients to ensure client satisfaction through strong relationship management.

Responsibilities

• Responsible for project delivery oversight of assigned Emmes Book of Business globally.
• Collaborates Therapeutic Leads and subject matter experts to develop Best Practices, Monthly project reviews, Templates library, Bid Defaults.
• Consults in the development of RFPs for biopharma clients, identifying appropriate strategy, team structure, preparing proposal language, and developing budget and timelines in collaboration with leaders and key subject matter experts (SMEs).
• Provide ongoing mentorship, coaching, feedback, and ongoing training to Project Managers including addressing performance issues, conducting formal performance appraisals, and creating development plans.
• Ensures appropriate training occurs and evaluates proficiency or additional training needs of PM staff.
• Provides oversight of operational deliverables and financial health of projects.
• Serves as a point of escalation for PMs, sponsors, and other functions relative to overall project management in a study governance capacity.
• Develops successful working relationships with clients, executive management, and functional leads to provide oversight of project issues, proactively identify and mitigate risks and drive milestone achievement.
• Ensures PMs are tracking project deliverables against contract using Emmes' tools & Key Performance Indicators, as defined by the project or organizational metrics.
• Reviews study metrics to ensure risk mitigation and performance according to contract.
• Monitor trends and drive changes to project management as needed.
• Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables.
• Ensures changes in scope are identified and managed appropriately.
• Support PMs in collaborations with Business Development, Contracts Department, and executive management to ensure timely execution of contract amendments/change orders.
• Presents and prepares PMs to present in bid defense meetings in collaboration with Business Development Lead or other key stakeholders.
• Identifies and documents lessons learned from study successes and challenges to promote development of best practices and work with global colleagues to develop or revise standards for best practice.
• Support the identification and implementation of tools and process integrations that support the efficiency and productivity of PMs.
• This may include, but is not limited to collaboration with internal stakeholders and vendors to support global, PM efficiency and standardization within the department.
• Models and propagates Emmes' commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients.
• Other duties as assigned.

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum 7 years demonstrating scientific principles appropriate in managing a clinical research portfolio inclusive of 3 or more years in a pharmaceutical and/or CRO setting, serving in a global Clinical Trial Team Lead or Project Management role or equivalent position.
• Demonstrable track-record of success delivering complex/high priority clinical trials within agreed time, quality and cost working across multiple therapeutic areas, phases 1-3, in a global capacity.
• Demonstrated experience in developing and fostering strong client and internal relationships.
• Thorough understanding of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) and knowledge of SOP's guidelines and regulatory requirements.
• Skilled in MS Office Suite of products and working knowledge of Clinical Trial Management Systems, electronic Trial Master File, and electronic Data Capture systems and solutions and project support tools.
• Demonstrated experience in managing diverse staff and leading successful teams with direct and indirect supervision responsibilities.
• Travel between corporate locations and client sites as appropriate.