Study Director 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.
The core purpose of the Clinical Development Director is to provide scientific leadership, direction, and contribute to the strategy employed in ViiV Healthcare clinical development programsThis role also includes scientific leadership of the asset study team in the design and development of high quality, timely studies ('end to end' from Commit to Study to reporting, submission and publication). This role contributes to governance and regulatory reporting at the study level by collaborating across functional lines to ensure accuracy, quality, and timeliness of study results.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Helps drive the strategy of ViiV Healthcare early- and/or late-stage development programs
• Accountable for the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfills strategic objective of clinical development/ integrated evidence plan.
• Liaises with Operations, Clinical Pharmacology, Medical, Regulatory and Commercial Leads to ensure study/program evaluates key aspects of the Asset Target Product Profile critical to product differentiation/reimbursement where possible.
• May co-lead Clinical Matrix Teams with the accountable physician
• Provides scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with protocols, thereby allowing for intended scientific interpretation of study data and results.
• Partners with study team to ensure that all regulatory reporting requirements are met.
• Collaborates with physicians and other study team members and stakeholders to enable appropriate review of safety data. May assist or take leading role in identification of safety review committee members and preparation of interim safety review charter document. Works closely with study physician(s) to help monitor safety and benefit/risk for studies.
• Works with the study team to help to create evidence generation and scientific outputs including content of investigator meeting, clinical study report, preparation of study results for scientific meetings, congresses, and external journal publications, preparation regulatory documents, and other relevant study documents.
• Partners with clinical operations colleagues to help ensure optimal delivery of study while maintaining close collaborations with other functions supporting the study.
• Contributes to quality assurance and inspection readiness activities.
• Coaches and mentors team members
• Partner across ViiV Healthcare and the broader GSK enterprise to provide clinical science, R&D, and ViiV Healthcare perspectives on key business priorities.

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

• B.S. OR Masters OR Ph.D. OR Pharm.D., with 5 plus years of recent drug development experience in a pharmaceutical industry or CRO environment leading the scientific aspects of clinical program(s) and regulatory submission(s).
• Prior drug development experience in HIV / infectious diseases.
• Experience in working with or writing study protocols, informed consent forms and clinical study reports.
• Experience with reviewing and interpreting clinical and scientific data.
• Experience in contributing to end-to-end clinical development strategy, including study design, data interpretation, risk assessment, and milestone planning.
• Experience translating complex study-level issues into broader program-level recommendations and decisions.
• 5 plus years leading cross-functional teams, including internal and external partners (e.g. 3rd parties, academic partners, and subcontracted organizations).
• Experience with managing multiple programs concurrently.

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

• HIV drug development experience, including experience across multiple phases of development and contribution to regulatory interactions/submissions.
• Strong track record of influencing cross-functional strategy and driving alignment across internal and external stakeholders without formal authority.
• Ability to communicate complex scientific and clinical information effectively to senior governance forums and cross-functional leadership teams.

#LI-GSK
#LI-ViiV
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 a truly 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/