Pharmaceutical Product Manager at FHI360

Job Title: Pharmaceutical Product Manager

Job Location : United States of America

Time type : Full time

About The Company

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today’s interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.

As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.

Are you looking for an exciting opportunity to make an impact during the current COVID-19 pandemic?  FHI 360 is looking for a Pharmaceutical Product Manager for the COVID-19 Prevention Network (CoVPN) and for the HIV Prevention Trials Network (HPTN).  CoVPN was formed to evaluate vaccines, monoclonal antibodies and other agents for the prevention of SARS-CoV2 infection and the resulting COVID-19 disease. COVID-19 is continuing to have a profound impact on families and communities that will last for years to come. HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that develops and evaluates the safety and efficacy of interventions designed to prevent the transmission of HIV. From the existing need to address global health issues to the urgent need for pandemic control and response, to the eventual rebuilding of economies — FHI 360 will be here through it all.  COVID-19 may be new to the world, but our ability to respond quickly to emerging infectious diseases is not.

If you are looking for stimulating work in the clinical research arena and want to make an impact on the world, then look no further and apply now.

Position Overview:

We are looking for a Pharmaceutical Product Manager. This position will be responsible for all aspects of the study product management for clinical trials. Manage activities related to planning and execution necessary to ensure timely and continuous drug supply for global clinical studies. Serves as a key interface between the Clinical Operations team at the Operations Center, product storage and shipment centers (drug depots) and clinical research sites in matters of product supply.

They will be responsible for all aspects of study product management for HIV and COVID-19 domestic and international clinical trials Phase 1 to Phase 3 ranging in size from 20 to >3000 participants for multi-national clinical trial networks. Study product management includes but not limited to protocol development (pharmacy-related sections), product supply chain management, and regulatory compliance.

Accountabilities:

The ideal candidate will be responsible for

• Planning, organizing, and directing the activities of all study-site staff engaged in the preparation, management and dispensing of study product medications in the Pharmacy Department.
• Oversight of manufacturing and labelling vendors and any drug depots
• Ensuring timely distribution of product to the sites, maintaining adequate product inventory on site, oversight of drug accountability at sites and closeout activities related to product at sites.
• Developing the pharmaceutical section of the study procedures manual and providing applicable training to all study site pharmacy staff.  
• Overseeing and understanding study product data including, pharmacokinetic information and many other clinical pharmacy functions as part of the clinical trial team.
• Demand planning and forecasting – able to translate clinical study synopsis/protocols into actionable drug forecasts
• Product Supply strategies –Develop effective packaging and supply strategies maximizing available inventory by location and shelf life while minimizing waste and potential obsolescence as needed
• Distribution and Logistics – set up, manage and monitor global distribution networks based on study requirements. Collaborating with others to ensure required Import/Export documentation is available
• Traveling to all of the clinical sites participating in a trial may be required to conduct training

Education and Experience:

• Pharm D with five years of direct product management experience for clinical trials in a pharmaceutical company or a clinical research organization or a Masters with 7 years of experience of direct product management experience for clinical trials in a pharmaceutical company or a clinical research organization

Typical Physical Demands:

• Typical office environment.
• Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
• Ability to sit or stand for extended periods of time.
• Ability to move 5 – 25 lbs.

Technology to be Used:

• Personal Computer, Microsoft Office 365 (i.e. Word, Excel, PowerPoint, Skype/TEAMS, e-mail).

Travel Requirements:

• 10% – 20%

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

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