Clinical Science Program Lead - Immuno-Oncology

Site Name: Cambridge 300 Technology Square, Switzerland - Zug, UK - London - Brentford, USA - Pennsylvania - Upper Providence Posted Date: Jan 25 2022 Key Responsibilities: Provide clinical science leadership, input, and oversight of multiple clinical studies either on a late stage asset or across multiple early phase clinical programs. Understand the asset's biological mechanism, clinical strategy, scientific interpretation of disease and target based literature. Provide input on clinical development plans for Early Development or Medicine Development Teams. Line manage and/or mentor of other more junior clinical development scientists. Ensure high quality protocol development aligned with the CDP to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe. Lead or contribute, as appropriate, to the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; with demonstrate ability to incorporate global considerations into strategic and operational decisions. Summarize and provide interpretation of study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population. Partnering with the Clinical Development Lead to ensure patient safety during the study lifecycle, and ensuring that study objectives fulfill regulatory and reporting requirements, and support medical governance Integrate data from internal, and external academic, conference and competitor sources. • Understand and support creation and support of competitor landscape, medical need, regulatory strategy. Appropriately interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc. Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical study/Clinical Development plan (CDP). Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents. As appropriate, Lead Clinical Matrix Teams. Why You? Basic Qualifications: Bachelor's of Science degree or related field of study. 8+ years of clinical research experience 5+ years of experience in Pharmaceutical industry. Foundational experience as study coordinator, CRA, and clinical research professional at a CRO will be valued. 3+ years of Oncology Clinical development Director level leadership experience across a late stage asset or several early stage programs/studies, with preferred experience in immuno-oncology. Prior line management experience of clinical managers/clinical scientists (2-5 reports), with experience at performance review, resource allocation, and hiring processes. Preferred Qualifications: Additional advanced degree (e.g. MS, PhD, PharmD) Solid understanding of clinical trial execution/key operational considerations of how clinical trials are conducted. Demonstrated leadership, mentorship, and influencing skills in a matrixed environment. Experience taking strong cross functional leadership role in clinical development; experience & understanding of clinical development from early stage through to regulatory submission and market support. Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment. Good knowledge of disease-specific research priorities, competitor landscape, clinical practice trends and treatment guidelines evolution Broad understanding of the pharmaceutical industry and the clinical development process Highly developed communication and interpersonal skills appropriate to the target audience and senior stakeholders, promoting effective decision-making where necessary 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. *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.