Senior Director, Clinical Pharmacology Leader, ViiV (Potential Remote Opportunity)
Site Name: Stevenage, UK - London - Brentford, Upper Providence, USA - Connecticut - Branford, USA - North Carolina - Research Triangle Park Posted Date: Jul 8 2021 *Remote Opportunity for the Right Candidate *As a ViiV Employee, you are also a GSK Employee 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-centred 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. ViiV Healthcare is recruiting for a Senior Director, Clinical Pharmacology Leader who will provide translational, clinical discovery and development strategic leadership and oversight for the ViiV Healthcare portfolio. This is a great leadership opportunity for a candidate with 10 plus years of experience, expertise in biologics, immunology, long-acting therapies and/or novel delivery technologies, and great collaboration skills. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: ViiV clinical pharmacology strategic leader for specific development program(s) in the ViiV portfolio. Broad strategic input and decision-making as a leader and/or member across VH R&D enterprise governance and committees. Ability to incorporate information from non-clinical (DMPK, virology, biology, pharmaceutical development), and other relevant disciplines and maintain an advanced knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics such that the benefit of clinical pharmacology principles can be fully optimized for patient and drug development benefit. Ability to integrate available data, competitor information, thought leader consultation, etc., in decision making. Strategic input and review of clinical pharmacology and modeling and simulation plans into overall project and clinical development plans and strategies. Approve strategy, analysis plan, and report for PK/PD or exposure-response and population PK-PK/PD analyses. Review clinical pharmacology contributions to development program(s), concept protocols, protocols, and reports at all stages of development (CS, Ph1, Ph2a, PK/PD in Ph2-4, and investigator sponsored studies). Review and approve the clinical pharmacology components of all regulatory documents (including CTD modules, m2.7.1, m2.7.2, specific sections of m2.5) and responses such that ViiV Healthcare products are rapidly and efficiently approved or updated with optimum labeling for patients and providers. Review and approve relevant abstracts, presentations, publications; publish in appropriate scientific journals. Leads initiatives to improve quality, efficiency or adherence to standards, including cross-functional initiatives across multiple departments via review and development of procedural documents. Ability to represent ViiV in public fora and with regulators. Strong critical thinking and analytical skills; critically review results of PK, PK/PD, and population PK/PD analyses performed by others. Participate in due diligence activities to critically assess clinical pharmacology, PK, PK/PD and pharmacometric data/information to inform asset profile. Use sound judgment when working with critical or confidential information. Develop and maintain contact with internal and external scientific experts. 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. 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. May manage clinical pharmacology staff; serve as a clinical pharmacology mentor and coach, both internally and externally. 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: Ph.D., Pharm.D., or M.D. with experience in leading and applying translational and clinical pharmacology, biopharmaceutics, and quantitative/modeling principles towards efficient and informed drug discovery and development strategy, risk management, and registration of drug candidates. 10 plus years of clinical pharmacology or related pharmaceutical development experience. Leadership experience with biologics, immunology, long-acting therapies and/or novel delivery technologies Preferred Qualifications: If you have the following characteristics, it would be a plus: Expertise in the driving strategy and application of translational and model-informed drug discovery and development knowledge. Thorough knowledge of pharmacology, immunology, virology, metabolism/transporters, biopharmaceutics, regulatory affairs, therapeutics and commercialization such that he/she can assist in managing these interfaces. Ability to effectively collaborate and lead internal and/or external matrix teams is required. Excellent working knowledge and experience in quantitative clinical pharmacology, including Population PK and Exposure-Response analyses and simulations for clinical and non-clinical study design. Expertise in the planning, design, interpretation and reporting of clinical PK and Population PK and Exposure-Response analyses and simulations importantly informing dose selection for various populations. Thorough understanding and ability to apply appropriate regulatory guidelines in the design of clinical pharmacology development plans, studies, and regulatory submissions. 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. 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. 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 GSK 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. *LI-GSK *LI-ViiV 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.