Vice President, Global Regulatory Affairs Therapeutic Groups, Oncology
Site Name: UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Jul 8 2021 Are you ready to lead global regulatory affairs for the entire GSK Oncology/Hematology portfolio? This role can be primarily based at either of the GSK Oncology R&D sites in Collegeville PA or Waltham MA. Preferences for other US locations, GSK European hub countries (UK, Belgium, Switzerland) and/or flexible remote working arrangements will also be considered and should be discussed with the GSK recruitment team and hiring manager during the selection process. About Oncology at GSK GSK is committed to the discovery and development of new and potentially life-changing therapies for patients with cancer. Our vision is for people with cancer to not only to live, but to live well. Our goal is to achieve a long-term leadership position in Oncology by delivering transformational medicines that maximize patient survival. Our Oncology R&D is focused on building industry-leading portfolios in four cutting-edge areas of science: Immuno-Oncology: using the human immune system to treat cancer Cell/Gene Therapy: engineering human T-cells to target cancer Cancer Epigenetics: modulating the gene-regulatory system of the epigenome to exert anti-cancer effects Synthetic Lethality: targeting two mechanisms at the same time which together, but not alone, have substantial effects against cancer Our exciting oncology portfolio includes several opportunities for first or best in class monotherapy agents in addition to significant opportunities for potentially transformative combination therapies. Our strategy is to foster innovation and leverage internal and external partnerships to enable combinations and accelerate development. GSK continues to invest heavily in oncology. Since July 2019, we have roughly doubled the number of oncology assets in clinical development through the advancement of our internal programs and with targeted business development, including the acquisition of Tesaro and our alliances with external partners such as iTeos, Adaptimmune and IDEAYA. Learn more about our work in oncology: https://us.gsk.com/en-us/careers/a-career-in-oncology GSK's Oncology Transformation: https://www.lifescienceleader.com/doc/building-gsk-oncology-r-d-0001 The current GSK Oncology R&D pipeline: https://www.gsk.com/en-gb/research-and-development/our-pipeline/?oncology About the Role - Vice President, Regulatory Affairs, Oncology Therapeutic Groups As the VP, Regulatory Affairs, Oncology Therapeutic Groups, you will be responsible for the development and implementation of innovative regulatory strategies to ensure the successful progression of GSK's oncology assets from discovery and early development, through regulatory approval, optimal reimbursement and launch, and life cycle commercialization. You will own full accountability for overseeing global regulatory submissions and the associated communication strategy to all regulatory authorities for the entire GSK oncology portfolio, including multiple oncology disease areas (solid tumors, hematological malignancies and rare cancers) across our four areas of strategic focus: Immuno-Oncology, Cell Therapy, Epigenetics and Synthetic Lethality. This role has been expanded with our acquisition of the Tesaro portfolio, the growth and progression of our broader oncology portfolio and the additional accountability for companion diagnostics and digital health aspects. In turn this has led to a significant increase in the size of the group, from 10 to 40+ staff over the last two years, with further growth expected as the GSK oncology portfolio continues to expand. In the last 24 months the team has enjoyed the following notable successes: Following an announcement in March 2020 that the FDA was suspending all its on-site inspections, the Oncology RA team led on the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application with a remote inspection by FDA leading to approval. August 2020: FDA and EMA approved Blenrep as first in class anti-BCMA therapy, for Heavily Pretreated Multiple Myeloma. Assets from Tesaro integrated effectively to the GSK pipeline and progressed without interruption to the development plan. Key Responsibilities: Lead global regulatory Oncology therapeutic teams to deliver global regulatory strategies and inform the development and implementation of policies and strategies for optimization of drug development. Lead the team to ensure effective collaboration with other groups within Global Regulatory Affairs, R&D, commercial and Supply. Represent Global Regulatory Affairs and provide key input to Oncology Review Committee, Oncology R&D Leadership Team and Oncology Therapy Area Board. Lead expertise for companion diagnostics and digital health. Ensure effective global regulatory strategies to support the development of biomarkers, companion diagnostic tests, digital health including Artificial Intelligence/Machine Learning (AI/ML), Mobile Apps and other devices. Act as a credible, influential, respected spokesperson during interactions with international regulatory agencies and external organizations, and ensure appropriate, proactive communication with agencies to assure expedient and efficient review and approval of GSK submissions. Represent GSK at public workshops with key Oncology stakeholders, including, FDA, ASCO, and FOCR. Serve as an external industry leader and influential spokesperson in support of GSK's global regulatory initiatives and key strategic external collaborations. Oversee regulatory submissions globally for the assigned Oncology therapeutic portfolio, including the associated communication strategy to all regulatory authorities. Ensure that sound regulatory practices are fully integrated into pre-clinical, clinical and technical submissions, and that all documents submitted to regulatory agencies are appropriately reviewed to ascertain that they are complete, scientifically accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review. Serve as a senior internal leader and the responsible head who ensures appropriate regulatory compliance in the conduct of global development programs and product maintenance activities for the oncology therapeutic portfolio. Drive development of novel concepts and approaches to advance and/or challenge existing regulatory paradigms. Provide strategic regulatory leadership and guidance to senior GSK executives on regulatory matters. Provide leadership and input into the development and implementation of the overall strategic direction of global regulatory affairs within the Oncology Therapeutics, companion diagnostics and digital health. Drive business critical “above projects” that may be identified and prioritized by the GSK business as necessary. Provide global regulatory strategies commensurate with the Development strategies in support of registering new products, line extensions and maintaining product licenses based on business priorities. Lead, mentor and guide a team (including succession and development planning, performance management, recognition and recruitment) of senior regulatory professionals recognized for their customer focus and regulatory and scientific acumen. Monitor and anticipate regulatory, scientific and pertinent legal issues and assess potential impact on GSK; to advise management on events of significance to the Company's business interests; influence changes in guidelines and regulation to strengthen the regulatory review process and ensure core operations are proactively aligned with emerging policies. Drive discussions, apply problem solving skills and secure appropriate consensus and/or decisions that are supported by the evolving regulatory environment by applying effective communication and influencing skills at all levels. Ensuring and achieving the above accountabilities has a direct impact on the development and growth of the GSK Oncology portfolio and on ensuring delivery of success factors including competitive labelling, successful approval, compliant and reliable supply, and maintaining GSK's corporate reputation. Why You? Basic Qualifications: Educated to at least Bachelor's degree level. Ideally a higher degree (MSc, PhD, MD, PharmD etc.) in a relevant life science or clinical discipline. Senior leadership track record in pharmaceutical regulatory affairs, including significant experience in the oncology/onco-hematology therapy area. Deep scientific understanding to direct drug development programs on clinical and broader technical requirements. Advanced scientific knowledge and capability to drive scientific decisions internally and with external agencies and scientific communities. Able to influence and engage at senior level governance boards to direct and lead regulatory strategies and submissions. Experience leading the development of regulatory strategy and interacting to affect direction and decision making within development programs; Experience working in early phase and late phase development projects as well as lifecycle. Gravitas to negotiate within a highly matrixed environment to deliver complex messages and facilitate appropriate team decisions. Strong management and project leadership skills, ability to provide operational oversight and support project teams in strategic decisions and guide them through diverse and conflicting regulatory requirements. Proven ability to develop collaborative relationships and have high impact and influence. Ability to multi-task and excel in cross functional settings and to manage multiple projects in a fast-paced environment. Demonstrated strategic capability and ability to see the overall ‘big picture'; Insightful and forward thinking, ability to recognize, anticipate and review/discuss potential regulatory challenges with teams, and present management with recommendations that reflect full consideration of available options. Ability to read, analyze and interpret complex regulatory documents and to respond effectively, formulating effective solutions compliant with external regulations. Advanced knowledge of drug development process and laws and regulations affecting the pharmaceutical industry in key jurisdictions, particularly US, Europe, China and Japan. Proven track record of effective collaboration with the FDA/EMEA/PMDA/CFDA/significant agencies and a history of success in gaining product approvals and defending established products. Ability to assimilate varying perspectives, information and data from many different departments at all levels and consolidate that information with guidelines, regulations and other requirements to develop, articulate and execute on innovative regulatory strategy. Proven capability and highly effective in presenting to senior levels, with good influencing skills to ensure that the voice of GSK Global Regulatory Affairs is clearly articulated and heard by both internal and external audiences. Evidence of proactive leadership to identify issues and mitigation strategies and maximize opportunities. Culturally aware and experienced in working with diverse cultures and in a matrix team environment. Able to work with remote teams/individuals and manage these teams through influencing skills while understanding and exhibiting sensitivity to different working styles. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK 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. 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