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ViiV Healthcare (GSK) Counsel - R&D and Global Medical

Gsk

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Yesterday

Location
Durham Blackwell Street, United States of America
Workplace
Remote
Type
Full-time
Department
Healthcare
Source
Workday

Description

ViiV Healthcare — the only company solely focused on HIV — is committed to advancing science, medicines and access for people living with or affected by HIV. As part of the GSK group, ViiV combines deep HIV expertise with global R&D, medical and commercial capabilities to discover, develop and deliver innovative medicines across the HIV treatment, prevention and cure landscape. This role sits within ViiV Legal and will support ViiV’s R&D and Global Medical organizations as they advance ViiV’s portfolio, collaborations and evidence-generation activities in a highly regulated global environment.

As the Counsel, R&D and Global Medical, you will provide practical legal support to ViiV’s R&D and Global Medical organizations, partnering with legal colleagues and cross-functional teams to support clinical development, medical affairs, evidence generation, research collaborations and portfolio activities across ViiV’s HIV-focused pipeline and marketed medicines. You will advise on legal, privacy, contracting, governance and risk-management issues arising across the medicine lifecycle, with a focus on helping teams make well-informed decisions in a fast-moving global environment. The role requires sound judgment, clear communication, collaboration and the ability to translate legal advice into actionable guidance for scientific, medical and development colleagues.

This role will be based out of Durham, NC & may be considered 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 the opportunity to support key activities across ViiV’s R&D and Global Medical organizations. Responsibilities include:

  • Work closely with business colleagues supporting R&D, Global Medical, clinical development, privacy, intellectual property, compliance and contracting to deliver integrated legal support across ViiV’s portfolio and external collaborations.

  • Draft, negotiate and review a range of R&D and Global Medical agreements, including clinical study, investigator-sponsored research, academic collaboration, consortium, data-sharing, sample-use, advisory, service and external engagement arrangements, working with internal clients and contracting teams to ensure appropriate risk allocation and operational clarity.

  • Coordinate with specialist Legal and Compliance colleagues, including Global Intellectual Property, Digital Privacy and Cybersecurity, Regulatory, Compliance and the Legal Contracting Network, to support timely, practical and aligned legal advice for ViiV’s R&D, medical and external scientific activities.

  • Identify, assess and communicate legal and business risks arising from clinical development, medical affairs, evidence generation, data use, collaborations and external scientific engagement, and advise on practical mitigation, governance and escalation options.

  • Work with Quality, Risk Management, Privacy, Compliance and Regulatory colleagues to advise on governance and risk issues relating to clinical studies, real-world evidence, medical activities, data use, human biological samples and scientific collaborations.

  • Support the review and interpretation of pending or new legislation, regulations, guidance or policy developments impacting ViiV’s R&D and Global Medical activities, working with Legal, Compliance, Regulatory and Policy colleagues to help assess business impact and appropriate responses.

  • As needed, support legal work relating to clinical development, registration, post-approval evidence generation and lifecycle activities for one or more ViiV medicines or pipeline assets, working with senior legal colleagues and subject-matter experts as appropriate.

In accordance with GSK Performance with Choice principles, presence in the office 2-3 days each week is required.

Why you?



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

  • Qualified lawyer authorized to practice in the US

  • 3 plus years of relevant private practice and/or in-house legal experience, including life sciences, pharmaceutical, healthcare, corporate, transactional, litigation, regulatory or other experience involving complex legal analysis, risk assessment, contracting, governance or client counseling.

  • Experience advising on contracting, privacy, data governance, clinical studies, medical affairs, research collaborations, human biological samples, publications or external scientific engagements.

  • Working knowledge of intellectual property issues relevant to research collaborations, clinical studies, data, samples, publications and external scientific engagements, with ability to partner effectively with specialist IP counsel.

  • Strong written and verbal communication skills in English, with ability to explain legal issues clearly to non-lawyers

  • Ability to provide clear, practical legal advice under tight timelines and changing priorities, with appropriate escalation of complex or higher-risk issues.

  • Ability to work collaboratively in a matrixed environment, build trusted relationships with legal and business colleagues, and escalate appropriately when legal or business risks require senior input.



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

  • Experience working with cross-functional R&D, clinical development, medical affairs, regulatory, compliance or commercial teams in a life sciences or healthcare setting.

  • Familiarity with digital health, artificial intelligence, real-world evidence, data analytics or other technology-enabled activities in a regulated life sciences environment.

  • Experience coordinating with subject-matter experts and cross-functional stakeholders to support timely, practical legal advice.


#LI-ViiV

#LI-GSK


Skills

Business Acumen, Critical Thinking, Data Privacy, Legal Document Review, Legal Strategies, Negotiation, Risk Mitigation Strategies, Stakeholder Management

 

 

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 - [email protected]

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/

Skills

CybersecurityRisk ManagementComplianceProcurementNegotiation
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