PROFESSIONAL SUMMARY

Strategic Global Public Health Professional that is recognized for high-profile achievements affecting health outcomes, budgets, mitigation plans, client management, and adherence to increasing global healthcare quality and equity. Lead Global teams (Japan, China, Europe, Australia, France, Germany, Ireland, Korea, South Africa & India) and the USA of about 120 employees. Exceptional talent in Pharmacovigilance leadership, Project Management, Clinical Operations, Bid Defenses, SPSS, Mentoring/Training. Over 15 Years of Healthcare Industry Experience.

EDUCATION

Master of Public Health (estimated completion in 2023) Benedictine University

Bachelor of Science, Public Health Rutgers, The State University

EXPERIENCE

Acrotech BioPharma, East Windsor, NJ - Remote

Sr. Medical Affairs Manager/Project Manager (2019 – current)

Acrotech Biopharma was founded in 2018 as a global platform to commercialize innovative proprietary medications (PTCL, Dermatology, Healthcare, Neuroscience, Oncology, and Chemotherapy). This is a $10 million dollar company with over 100 employees. Acrotech has 4 locations (3 manufacturing & 1 headquarters). Reported to the Senior Vice President of Medical Affairs and managed three direct reports. Managed a departmental budget of $3.5 million dollars. Member of the Hiring Committee and the Investigator-Initiated Clinical Trials Review Committee.

●Manage over 20 project team priorities and expectations through 100% efficient and 85% effective planning.

●Provides leadership and subject matter expertise for department-sponsored project initiatives to meet deliverables specified in the project plans.

●Proactively anticipate,/track over 87 projects, and mitigate project-related issues and risks with a 99% ROI.

●Organize and communicate baseline schedules at 85% efficiency: with over a 99.5% follow-up with key clients.

●Analyzes existing quantitative and qualitative information for each project.

●Participated in CRO (Clinical Research Organization) selection and prepared over 10 Requests for Proposals (RFP's).

●Reviewed and approved the scope of work within timelines and budget for CROs ranging from $1 million to $3 million.

●Responsible for the development and execution of the global publication plan review and approval of publications.

●Establishes goals for each project. Ensures that project tasks are scheduled and completed in an accurate and timely manner in accordance with established project plans.

Allergan, Madison, NJ - Remote

Sr. Clinical Trial Manager Lead, Contract (2019-2019)

Allergan was formed in 1948 and is an American Pharmaceutical Company that has cornered the market on medical treatments for eyecare, neuroscience, medical, dermatology, aesthetics, breast enhancement, obesity intervention and urologics. It is a $16 billion dollar company with over 14,000 global employees. Managed a global (Australia, France, Germany, Ireland, Korea and South Africa) team of 10 Clinical Trial Managers and managed a budget of over $3 million. Member of the Mentoring and Hiring Committee.

●Provided deliverables/milestones at 95% efficiency & led Clinical Trial Applications (CTA) with a quality increase of 35%.

●Collaborated with the internal/external teams to increase compliance to 100% as defined by the clinical trial procedures.

●Subject matter expert in leading over 100 initiatives and/or processes; acting as a mentor to junior CTA team members.

●Responsible for 10 investigators; 100% compliance with the protocol, SOP’s, guidelines, and applicable regulations.

●Assigns project team resources to various project tasks in a manner that will effectively and efficiently meet project goals.

●Writes clear and concise documents, including project proposals and reports, and effectively communicates information to management, SMEs, and stakeholders.

●Controlled the execution of the project to the successful delivery of 100% of the scope, schedule, budget, goals and benefits.

●Participated in the planning of quality assurance activities and coordinate the resolution of unresolved audit findings.

●Manage assigned global clinical studies encompassing all aspects from start-up through close-out (reconciliation of the Trial Master File).

●Responsible for the selection, training and management of study personnel (internal/CROs) to ensure the efficient operation of the study objectives.

United BioSource Corporation, Blue Bell, PA - Remote

Project Manager (2018 – 2019)

United BioSource LLC is a $260 million dollar company and founded in 2003. It is a leading provider of pharmaceutical support services, partnering with biopharmaceutical companies to make medicine and specialty therapies safer and more accessible. It has offices in 9 states and 1900 employees. Reported to the Director of Drug Safety. Managed a global team (China, Japan, and Europe) of 70 employees with 3 direct and 67 indirect reports. Managed the Drug Safety budget of $2 million. Member of the Bid Defense Team, Hiring Committee and Think-tank Team on strategies to improve Project Management activities.

●Managed 10 projects independently and provided leadership to 7 stakeholders for an indirect increase in revenue.

●Developed three employees’ supervisory skills and provided direction resulting in a 15% improvement in productivity.

●Reviewed over 30 Requests for Proposals (RFP’s) and client selection for clinical trial analysis.

●Improved the global footprint in compliance for client observance report cards resulting in 10 out of 10 or 100%.

●Reviewed 10 global contracts and improved utilization by 20% by eliminating non-value items within the contract.

Quintiles IMS, Raleigh-Durham, NC - Remote

Drug Safety Senior Project Manager (2016 – 2018)

Quintiles is one of the leading global providers of clinical trials and commercial marketing services to the pharmaceutical and biotechnology industry. This company is worth over $55 billion dollars. QuintilesIMS has 50,000 employees conducting operations in more than 100 countries, dedicated to helping our clients improve their clinical, scientific, and commercial results. Worked with a global team (India, China & Japan) of 100 employees with 5 direct reports and managed a budget of $6 million dollars. Member of the Mentoring Team, Hiring Team Committee, and Leadership Initiatives Team.

●Managed 4 out of 10 complex clients with a result of 50% issue resolution within the initial 60 days of employment.

●Lead the analysis and writing of 10 weekly client reports and other client-focused deliverables.

●Provided program updates to 5 internal and 10 external customers per week resulting in improved communications.

●Worked with global teams to analyze operations and efficiency for over 30 clinical trial programs.

●Lead internal operational departments in resolving over 100 client issues within 3 months.

Covance Inc., Princeton, NJ - Remote

Drug Safety Project Manager (2014 – 2016)

Covance Inc. (now named Labcorp) was formed in 1968. Covance is responsible for innovations in areas including oncology, biomarkers/companion vaccines, data analytics, virtual clinical trials and commercialization services. Covance has over 70,000 employees and is worth over $16 billion dollars. Worked with global teams (India, Europe, China & Japan) team of 50 and 2 direct reports and managed budgets up to $1.5 Million dollars. Member of the Hiring Committee and Project Management Committee.

●Received the “ACE AWARD RECIPIENT for EXCELLENT SERVICE for Superior Project Management in 2015-2016

●Partnered with Development Program Lead (DPL) & Development Project Team (DPT) to lead five programs.

●Created and maintained over 10 cross-functional development plans, timelines, and budgets for each program.

●Facilitated interdependencies and downstream impacts to further support science-based business decisions.

●Ensured global system analysis was integrated for over 100 studies that increased productivity by 35%.

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