Associate Director, Global Regulatory Affairs, Oncology Diagnostics and Machine Learning
Site Name: USA - Pennsylvania - Philadelphia Posted Date: Oct 1 2021 The successful applicant will also provide medical device, digital health regulatory strategic support in the area of use of real-world data as applicable to regulatory strategy and serve as a resource for the evaluation of stand -alone medical and digital devices and in vitro diagnostic tests of interest to GSK. Prior experience in laboratory testing or diagnostics or regulation thereof is highly preferred. In this role you will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy to ensure the development program meets the needs of the key markets identified and the Medicine Profile. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: • Accountable to GRL or Head of Regulatory Affairs, Precision Medicine & Digital Health, for development of appropriate global regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK, reviewing, contributing and editing submission dossiers, and representing GSK with the regulatory agency. • Work with the MDT to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified and the Medicine Profile. Lead interactions with local / regional /global regulatory authorities. • Work within Oncology Global Regulatory Affairs capable of developing regulatory/validation strategies for the development and registration of companion diagnostics through laboratory-based tests or a commercial in vitro diagnostic test kit. • Work directly with the Medicines Development Team (MDT), the Global Regulatory Lead and the Biomarker/Diagnostics Development Leader within Experimental Medicines Unit to assess the diagnostic test needs for the companion medication and determine the strategy for the development and delivery of the diagnostic test for use in the clinical development program and for the product post-approval. • Experienced in determination of the regulatory options and the relative risk and benefits of various diagnostic test options and in thinking of innovative regulatory strategies for study risk determination, IDEs, PMA submissions • Work with cross-disciplinary team to determine a transition “bridging” strategy for laboratory-based tests used during the clinical development program to an in vitro diagnostic or a laboratory -developed FDA approved test at the time of drug product approval. • Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset. • Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input). Basic Qualifications: • We are looking for professionals with these required skills to achieve our goals: Requirements include: • Bachelor's required - (Master's or PhD Degree desired). • 5 or more years' experience and demonstrated success in companion diagnostic or medical device regulatory affairs . • Proven experience of submission and approval activities in global/local region(s) including track record of organizing and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority. • Extensive knowledge of clinical trial and licensing requirements in all key markets in the region and sound knowledge globally. Ideally, proven experience of leading regulatory activities outside local region. • Preferred Qualifications: If you have the following characteristics, it would be a plus: • Experience in line management • Excellent negotiation skills across levels within an organization and with external stakeholders • Ability to manage multiple projects and proactively plan • Experience in working with strategic partners/cross company collaborations • Experience in partnering with business development in due diligence efforts • Prior Oncology Therapy Area experience preferred Why GSK? ..... 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. In return for your expertise in these critical areas, GSK offers you the opportunity to showcase your skillset with a leadership that recognizes and rewards talent! #LI GSK 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK 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 GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 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 GSK. GSK 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, GSK may be required to capture and report expenses GSK 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 GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.