Medicine Development Lead, HIV - ViiV Healthcare

Purpose

As VP, Medicine Development Leader (MDL), you will strategically lead the optimal global development of a medicine at an asset level, acting as the single point of accountability for the medicine from clinical Proof of Concept (PoC) to Approval in the first major market(s).

By working with the various stakeholders across ViiV's Medicine Development matrix (R&D, Commercial, Manufacturing etc.), you will define the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy. You will create and lead the matrixed Medicine Development Team (MDT), which is responsible for representing the various disciplines required to optimally deliver the development of the medicine including Clinical Development, Medical, Commercial and Manufacturing, amongst others.

Responsibilities

• Acting as a single point of accountability in ViiV for all aspects of a medicine being developed globally, from clinical PoC to Approval in the first major market(s)
• Working closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
• Post-approval, provides key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets
• Works with the functional line Heads to select MDT members and leads this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
• Leads the cross-functional MDT to:
  • Establish a compelling vision for the medicine within the R&D strategy taking the competitive landscape into account, translating ViiV's strategy into actionable plans for multiple areas or functions
  • Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product's life cycle
  • Prioritize and maximize the asset's development options including developing multiple indications
  • Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.
  • Make clear evidence-based go / no go / accelerate decisions and identify clear inflection points, based on whether the results fulfil the strategy set out for the medicine
  • Ensure excellence in execution of all governance processes, including MDT members, e.g., the Clinical Development Lead (CDL) partnering with other matrix Leads, such as the Global Regulatory Lead (GRL), the GML, etc. on oversight of clinical studies, patient safety & pharmacovigilance, scientific engagement and promotional practices
  • Enhance patient focus by incorporating the voice of the patient into development plans
  • Increase visibility amongst the external communities (physicians, regulators, patients, payers) to bring medical solutions to patients with unmet medical needs, thereby enhancing ViiV's reputation and showcasing our ambition for patients

• Embeds core processes including cost efficiency, adoption of new technology, risk identification & management, compliance with policy
• Promotes organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders
• Collaborates with other stakeholders, in particular EDLs and other MDLs, to share knowledge and optimal ways of working
• Ensures quality & compliance oversight in line with R&D expectations and project needs; ensures quality of data and science
• Serves as the asset's single point of contact and spokesperson to Senior Management, senior boards, other relevant internal governance committees and external Advisory Committees
• Delivers and manages the asset resourcing plan (people & finances), including serving as the single point for accountability for managing the asset budget to the agreed variance

Basic Qualifications & Experience:

• MD, PharmD or PhD with a specialism in infectious diseases
• Filing experience with BLA/NDA/MAA submissions as a core responsibility
• Extensive clinical development expertise and industry experience
• Experience in product development and/or commercialization, especially in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
• Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills
• Understanding of the entirety of drug development across the R&D/commercial life cycle to allow impact across all functions: Discovery, late-stage Development, Regulatory, Manufacturing, Medical and Commercial
• Experience working with regulators and with regulatory requirements including an understanding of the legal and government frameworks within and across global geographies
• Strong people management, leadership and motivational experience
• Experience in creating the strategy for pre- and post-marketing studies and driving the lifecycle process
• Experience of authentic alignment while leading high performing teams in a collaborative and purposeful manner to achieve defined objectives
• Experience of building budgets and leading the strategic and budget planning process
• Track record of leading with high operational complexity, including global, geographically dispersed teams, multi-disciplinary structures with high accountability, minimal authority and multiple lines of reporting.

Preferred Qualifications

• MBA or equivalent is highly preferable

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 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 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. 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/