Director, Device Strategy

Site Name: Home Worker - USA, UK - Hertfordshire - Stevenage, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Aug 27 2021 AS AN EMPLOYEE OF VIIV HEALTHCARE, YOU ARE ALSO A GSK EMPLOYEE RECEIVING 100% OF THEIR ROBUST TOTAL REWARDS AND BENEFITS ViiV Healthcare is an independent, global specialist HIV company combining the HIV expertise of GSK, Pfizer and Shionogi, with a broad portfolio of antiretroviral medicines, an industry-leading pipeline, and several first-of-their-kind programmes to improve access to medicines and support novel on-the-ground community initiatives. ViiV Healthcare has established presence in 16 countries and we are uniquely positioned to be at the forefront of advancing HIV treatment and care because we are the only pharmaceutical company 100% focused on HIV. Through our focus on patient-centered innovation we have developed a strong portfolio of medicines that are advancing treatment and care for people living with HIV around the world. Our broad product portfolio includes a range of therapeutic options throughout the treatment spectrum. The primary focus is on the growth portfolio namely dolutegravir and cabotegravir based regimens as well as other assets and asset combinations from phase IIb through to in-market such as Tivicay, Triumeq as well as Juluca, Dovato, CAB/RPV, CAB prevention, fostemsavir, Maturation Inhibitors and other novel agents early in development pipeline. A central component to the long-term ViiV Healthcare strategy is to develop an industry-leading portfolio of patient-centric, long-acting products for treatment and prevention of HIV to meet the diverse demands of patients around the globe. One important aspect of ViiV's long-acting strategy is to enable at-home administration which will provide patients with maximum flexibility and control. At-home administration will require ViiV to build and leverage novel auto-injector device platforms that will meet the needs of our diverse portfolio of small molecule and large molecule assets. The ViiV Director, Device Strategy will lead the development of several platforms in three phases aligned with our early development portfolio asset development timelines. This strategy involves careful consideration of formulation characteristics, primary container and device engineering, global regulatory issues, and manufacturing challenges. This strategy was developed in collaboration with GSK stakeholders including subject matter experts in primary packaging, device engineering, and global supply chain. We are looking for a candidate with a strong background in drug product and device development that can effectively work with internal stakeholders at ViiV and GSK to implement the ViiV device strategy. We are looking for candidates with a strong a combination of device engineering, manufacturing, and regulatory experience to drive a short and long-term device strategy customized for ViiV Healthcare's ambition to develop a new generation of patient-centric, self-administered drug products for HIV therapy and prevention. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Work with key internal stakeholders including, but not limited to, device engineering, primary packaging, formulations, supply chain, and regulatory organizations at ViiV and GSK to operationalize device strategy across assets Work with early development teams to integrate device development timelines into each project plan Lead cross-project interactions to ensure alignment with respect to device development Provide oversight to device development activities including primary pack selection Present updates to senior stakeholders within ViiV and GSK Work with GSK supply chain organization to plan and build device platforms for the ViiV portfolio Anticipate regulatory considerations for launch of device products globally Provide oversight of formulation innovation work that can enable longer term device selection Inform market research plans to gain patient insights into device presentations Scout and evaluate emerging device technologies that can be specifically used to enable key target product profiles for the ViiV pipeline Provide broad strategic input and decision-making as a leader and/or member across ViiV Healthcare R&D enterprise governance and committees Leads initiatives to improve quality, efficiency or adherence to standards, including cross-functional initiatives across multiple departments via review and development of procedural documents Participate in due diligence activities to critically assess drug delivery and device technologies Use sound judgment when working with critical or confidential information Develop and maintain contact with internal and external scientific experts Commitment to anticipate, influence and implement change. Manage situations as they arise, including urgent regulatory requests, rapidly changing development plans based on emerging data, etc. Implementing best practices, trends, learnings, etc from internal and external sources that could be applied to the functionality of and innovation for clinical pharmacology Ability to respectfully interact with senior and line staff, partners, external contacts on a functional and tactical level Evidence of sound scientific and ethical judgement Ability to meet target deadlines and manage time effectively, balanced across multiple programs and projects Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Master's degree in engineering, chemistry, or pharmaceutical sciences with 6 plus years of experience developing and integrating sterile drug products into devices for at home administration Experience in developing device and drug delivery platform strategies within R&D organizations. Experience with key regulatory requirements for device development in multiple markets Experience developing long-acting formulation and novel drug delivery technologies for small molecules or biologics Preferred Qualifications: If you have the following characteristics, it would be a plus: 10 plus years of experience developing and integrating sterile drug products into devices for at home administration Ph.D. in mechanical engineering, chemical engineering, chemistry, or other related disciplines with 7+ years of experience developing and integrating sterile drug products into devices for at home administration Strong external presence in the device and drug delivery network Project Leadership experience with devices Experience and knowledge of HIV medicine development Bias towards action to achieve goals; excitement, enthusiasm and a sense of urgency with regard to drug development strategy, questions, and opportunities Exercise sound business judgment when making decisions and adhere to external and internal policies and regulations Ability to successfully anticipate issues or challenges and proactively address without being specifically directed Strong critical thinking and analytical skills Highly effective verbal oral, written and virtual communication skills Established reputation for working within a team and developing cohesiveness; good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise; ability to garner support and coordinate resources in support of objectives Ability to prioritize, advise, influence and adapt to changing project needs and objectives for the ViiV portfolio in changing environments within and outside the company. Build contingencies in project or development plans to provide flexibility Why ViiV Healthcare? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As ViiV Healthcare focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. *LI-ViiV *LI-GSK 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. ViiVshall 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 ViiV's Transparency Reporting For the Record site.