ViiV Healthcare (GSK) Clinical Operations Director

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.

ViiV Healthcare was created as a joint venture by Pfizer and GlaxoSmithKline in November 2009 with both companies transferring their HIV assets to the new company. In 2012 Shionogijoined the company. 76.5% of the company is now owned by GlaxoSmithKline, 13.5% by Pfizer and 10% by Shionogi.

As an experienced Clinical Operations leader, the ViiV Clinical Operations Director will work in close collaboration with ViiV R&D project teams to provide operational and strategic leadership to the HIV matrix teams by working with functional area partners to deliver robust, fit for purpose clinical development plans and ensure ViiV clinical trials are delivered efficiently and to high quality standards. The role will have strategic oversight for operational delivery of clinical development plans across ViiV R&D. You will also be responsible for managing the strategic relationship with GSK Global Clinical Operations and external clinical service providers, such as clinical research organizations and central lab providers.

This role will be based out of ViiV's US Headquarters in Durham, NC (RTP Area) & is eligible for a domestic relocation package.Check out this link to learn more about the thriving, diverse, and cutting edge RTP area!

Research Triangle Park | Where People + Ideas Converge (rtp.org)

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

• To ensure global delivery of the ViiV clinical development plans ensuring high-quality and efficient delivery of clinical trials and regulatory submissions.

• Provide strategic and operational input to ViiV project teams on the design, planning, execution, and reporting of clinical trials, ensuring alignment with clinical development plans and regulatory requirements.

• Strategic input into the operational aspects of clinical studies, including but not limited to, country and site selection, vendor selection, feasibility / recruitment strategy, site monitoring, clinical study budget estimates, ensuring consistent approaches to study delivery across the portfolio.

• Oversight of Clinical Operations Service Providers to ensure high-quality delivery of ViiV clinical studies in conjunction with ViiV project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations.

• Foster a culture of innovation, continuous improvement, and excellence within the clinical operations function, promoting best practices and standards.

• Establish and foster effective communication and collaboration with internal and external stakeholders, such as ViiV senior leadership, functional area partners and GSK Global Clinical Operations

• Collaborate with GSK Global Clinical Operations to plan and implement resourcing strategy to address asset/study program requirements, timelines and changing workloads.

• Input into clinical trial risk identification & mitigation strategies at study level and across the portfolio

• Drive implementation of acceleration strategies, clinical trial diversity, DCT & Implementation Science across the portfolio

• ViiV Clinical Operations point of contact for assigned projects, including issue escalation and facilitation of resolution as needed.

• Work with the study team to identify, select and oversee third parties including but not limited to alliance partners, joint ventures, CROs, central labs etc.

• Supports ViiV clinical teams to embed best practices from service provider clinical development acceleration workstreams (e.g.STOM, GSK Upper Quartile).

• Collaborates with ViiV Head of GCP Quality to ensure study delivery is conducted in compliance with GCP and creates strategies to ensure GCP compliant delivery for clinical studies.

• Clinical operations input for partnerships with external clinical trial networks such as DAIDS networks (e.g., HPTN, IMPAACT, ACTG) and PENTA

• Collaborate with GSK Global Clinical Operations to plan and implement resourcing strategy to address asset/study program requirements, timelines and changing workloads.

• Input into clinical trial risk identification & mitigation strategies at study level and across the portfolio

• Drive implementation of acceleration strategies, clinical trial diversity, DCT & Implementation Science across the portfolio

• ViiV Clinical Operations point of contact for assigned projects, including issue escalation and facilitation of resolution as needed.

• Work with the study team to identify, select and oversee third parties including but not limited to alliance partners, joint ventures, CROs, central labs etc.

• Supports ViiV clinical teams to embed best practices from service provider clinical development acceleration workstreams (e.g.STOM, GSK Upper Quartile).

• Collaborates with ViiV Head of GCP Quality to ensure study delivery is conducted in compliance with GCP and creates strategies to ensure GCP compliant delivery for clinical studies.

• Clinical operations input for partnerships with external clinical trial networks such as DAIDS networks (e.g., HPTN, IMPAACT, ACTG) and PENTA

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science degree

• 10 plus years of Leadership experience in clinical operations in the pharmaceutical industry or CRO environment

• Experience leading projects / workstreams across multiple matrix teams (including resource and financial management), global regulatory guidelines and ICH/GCP

• Experience working with investigators, external experts, Contract Research Organisations and vendors. Leadership experience with senior stakeholder management

• Leadership experience with senior stakeholder management

• Experience in leading in a matrix team and / or direct line management.

• Experience with establishing and building internal and external relationships at all levels in a matrix environment.

• Infectious diseases experience

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

• MS, PhD, or PharmD

• Demonstrated ability to establish and build highly functional internal and external relationships at all levels in a highly dynamic and matrixed environment.

• Demonstrated ability to use robust analytical rigor to identity the critical issue in complex situations and to frame issues and opportunities in such a way that new perspectives can be found.

• Highly developed communication skills appropriate to the target audience which promote effective decision-making.

• Demonstrated experience leading in complex environment to deliver projects, develop clinical plans, manage change and ambiguity.

• Experience with marketing application submissions (e.g, MAA, NDA, BLA, JNDA etc)

• HIV (treatment and PrEP) experience

#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 39 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 diverse team and 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 ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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/