Medical Monitor Jobs in Raleigh, NC (NOW HIRING)

ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic.

We are aware of how much is at stake for those affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference.

While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities.
This Medical Director position is a critical role within the R&D Physician Center of Excellence, primarily serving as a Medical Monitor (MM). The MM will focus on Phase 1-4 clinical trials, ensuring the successful planning, execution, and reporting of protocols that align with ViiV's strategic mission of delivering innovative, long-acting HIV drug therapies to millions internationally. Reporting to a Senior Medical Director, this role involves crossfunctional collaboration with internal leaders and external stakeholders, contributing directly to the development of groundbreaking treatments and prevention strategies.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

Clinical Trial Management and Oversight

• Serve as Clinical Trial Director for Phase 1-4 trials, designing study protocols and supplementary documentation, including study procedures manuals, analysis plans, and protocol deviation plans.

• Provide medical governance, ensuring clinical and operational excellence in study execution.

• Manage study conduct, enrollment strategies, and interpretation of clinical data.

Safety and Medical Expertise

• Provide expertise in managing safety events and toxicity concerns.

• Train internal and external teams on protocol-defined safety parameters.

• Ensure comprehensive documentation of trial-related inquiries and safety events in the electronic Trial Master File.

CrossFunctional Collaboration

• Partner with internal teams in virology, pharmacology, biostatistics, drug safety, regulatory affairs, and discovery science to design efficient clinical studies.

• Collaborate with external investigators, consultants, institutional review boards (IRBs)/research ethics committees (RECs), and community stakeholders for trial feasibility, conduct, and reporting.

Regulatory Support and Reporting

• Assist in developing submissions for regulatory bodies (U.S. and international) during and post-study phases.

• Prepare responses to regulatory queries and present clinical trial findings to internal governance groups.

Team Leadership and Organizational Growth

• Foster strong professional relationships and teamwork within a matrix environment to drive project success.

• Thrive in a fast-paced, dynamic setting while demonstrating leadership and adaptability.

• Contribute to organizational growth and innovation, supporting the mission of global impact.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Licensed Physician (MD or DO)

• Completion of Internal Medicine or Family Medicine residency training

• 3 plus years of demonstrated expertise in Infectious Diseases, either patient care or research

• Drug development OR clinical trials experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Either clinical fellowship in Infectious Diseases, in HIV and/or extensive experience in HIV clinical treatment and management

• Expertise in conducting clinical trials, including 2+ years in drug development and execution of trials in HIV or infectious diseases

• Proven leadership experience in matrix environments and team collaborations

• Active medical license or equivalent qualification to practice medicine

• Exceptional communication skills with the ability to foster strong professional relationships across functional areas and with external stakeholders

#LI-ViiV

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee.

Why Us?

At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 40 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.

We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.

Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities.

Having atruly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at -usrecruitment.adjustments@gsk.com

ViiV is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/