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Program Management Project

Location:
Henrico, VA, 23231
Posted:
December 13, 2023

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Resume:

P a g e * *

Richard J. Goglia, Jr, MBA

Director, Global Project Management

ad1xyo@r.postjobfree.com • 973-***-****

https://www.linkedin.com/in/richard-j-goglia-jr-mba/ Henrico, VA

Summary

Strategic-thinking leader in Program/Project Management with over 15 years of experience, specializing in developing and expanding global program management practices and high-value portfolios for both established and startup pharmaceutical companies. Demonstrated success in crafting and implementing strategic project plans and overseeing the execution of complex, enterprise-wide programs. Proficient in collaborating with diverse team members to plan and execute strategies for global product development, commercialization, and life cycle management. Acknowledged as a Cross-functional Leader, driving multiple program teams to achieve project milestones, identify and mitigate risks, and ensure overall project/program success. Skilled in establishing robust and inclusive PMO frameworks, encompassing comprehensive systems, structures, processes, and procedures to maintain standards in a rapidly changing environment. Areas of Expertise

● Global Program Management

Organization Management

● Project Management

Organization (PMO)

● Risk Management/Mitigation

● Communication (Written &

Verbal)

● Strategic Project Planning &

Monitoring

● Leadership Coordination

● Project Metric Analysis & Reporting

● Contract Management & Negotiations

● Relationship Building/Mentorship

● Problem Solving

● Cross-functional Leadership &

Collaboration

● Stakeholder Management

● Drug Development Project

Planning & Delivery

● Governance

● Budgeting

Career Experience

Civica RX, Petersburg, VA Sep 2022 – Present

Director, Program Management

Strategic Site Leader responsible for Program and Project management activities at a greenfield pharmaceutical manufacturing facility. Hands-on mentality to develop and execute strategic plans for complex projects between internal teams, external vendors, and governing organizations for overall site readiness meeting patient and customer needs. Develop, implement, and mentor project management tools/systems/resource modeling amongst diverse cross-functional teams achieving program success.

• Implement a strong agile PMO framework, incorporating advanced program management tools and systems to establish a standard for best practices and enhance team engagement during the organizational transformation at the Petersburg site.

• Lead multiple cross-functional project teams in defining, designing, developing, and delivering organizational programs, projects, to understand all interdependencies and possible impacts.

• Drive and nurture the organization’s strategic vision across diverse teams, fostering alignment with corporate goals and promoting a unified voice on program scenarios to identify the optimal path forward.

• Manage and monitor program activities and resources for Program/Project Managers and Project Teams, diligently track project/program status, potential impacts, and implement escalation plans.

• Cultivate cross-functional collaborations among diverse organizational functions to propel project progress, eliminate bottlenecks, and identify risks, ensuring transparent communication on project status within the organization.

• Develop and integrate innovative project management tools and processes, including meeting governance and an escalation matrix, ensuring project transparency across the organization.

• Pioneer a novel tracking system for all site documents, including SOPs, Protocols, Forms, and Reports, optimizing workload planning and resource management.

• Partner with Site and Executive Leadership on Civica Petersburg program/project status reporting, metric analysis, and meeting established timelines and deliverables.

• Develop and mentor other project managers and teams to maintain focus in a changing environment and uphold the organization’s mission and goals.

• Collaborate with R&D and Regulatory functions, developing strategic plans for the submission process, data rendering, and meeting timelines for Abbreviated New Drug Application (ANDA).

• Spearhead a cross-functional team in strategizing, land acquisition, designing, and coordinating vendor engagements for the establishment of a standalone Research & Development and Quality Lab; mitigating external development and quality control partnerships.

P a g e 2 2

Mallinckrodt Pharmaceuticals/ IKARIA, Inc., Hampton, NJ Jun 2009 – Sep 2022 Director, Global Portfolio & Program Management

Senior Leader of the global portfolio and program management organization for a well-established pharmaceutical company. Conceptualized and executed strategic project plans within the R&D organization to advance organizational growth objectives in the US and international markets. Oversaw and coordinated programs from early development to commercial launch and life- cycle management. Managed and guided cross-functional global brand project teams and partnerships with sub-teams.

• Led the Terlipressin development team as Global Portfolio Director through 3 clinical trials, 4 NDA submissions, and 2 contract manufacturing organization shifts, supporting its drug development program throughout the entire product lifecycle.

• Secured FDA approval for Terlipressin for Hepatorenal Syndrome (HRS) in September 2022. Led a team in documentation preparation, submission, and resolution of multiple FDA challenges and concerns. The drug was also approved in Australia.

• Consolidated partner relationships and workflows through strategic alignment, removing roadblocks, and providing solutions for key assets domestically and abroad.

• Drove progress of INOmax for cardiovascular patients by leading the timely completion of successful clinical studies in Japan.

• Spearheaded the business case development and secured approval for executing a clinical study in Japan for Terlipressin.

• Collaborated closely with the engineering team in Dublin to build upgraded devices for INOmax and Therakos Brands.

• Ensured meeting project timelines by creating critical communication tools, operating cadence, project updates and presentations, timelines, budgets, scenario analysis, and program recommendations.

• Launched effective risk mitigation plans for functional/cross-functional risk management following the identification of the secondary packager’s receipt of 483s and inability to use them for NDA submission.

• Pioneered an innovative strategic plan with the Regulatory and Operation groups, transferring secondary packing to a new site and ensuring readiness for resubmission within a 3-month timeline.

• Build strong and trusted relationships with internal and external partners to understand strategic objectives and track program progress.

• Mentored and guided program line functions to implement complex, multi-faceted programs by translating organizational strategy into a project plan.

• Successfully promoted from Senior Manager, Project Management, Associate Director, Project Management to the current role by demonstrating outstanding strategic planning and leadership skills. Additional Experience

Project Manager, Pharmaceuticals Division, Alpharma Inc, Piscataway N.J. Associate Scientist/Project Manager, Pfizer, Inc, Morris Plains, N.J. Education

Master in Business Administration (Marketing), Rutgers Graduate School of Management, Newark, NJ Bachelor of Science in Biology, University of Dayton, Dayton, OH References

Russ Gall, Head of Manufacturing and Supply Chain, phone 314-***-****, email ad1xyo@r.postjobfree.com Stan Benson, Site VP/General Manager, phone 336-***-****, email: ad1xyo@r.postjobfree.com Laura Stearns, Sr. Director Global Program and Project Management, phone: 612-***-****, email: ad1xyo@r.postjobfree.com Additional References upon request



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