Site Name: USA - Pennsylvania - Philadelphia Posted Date: Mar 15 2022 Are you looking for a Senior Leadership opportunity to drive clinical development strategy for a multi-national pharmaceutical company? If so, this role may be for you! The Senior Director, Clinical Sciences Program Lead (CSPL) Oncology Clinical Development will report to the Vice President, Oncology Clinical Development -Cell and Gene Therapy (VP CGT) and will use leadership skills, scientific expertise and clinical background to provide input on clinical sciences and strategic issues that impact the progress and success of medicine development for patients. The Sr. Director, CSPL Oncology Clinical Development will also partner with the VP CGT to provide the clinical assessment of business development opportunities, including supporting technical diligence assessment and the development of proposed clinical development plans (CDPs) for these assets. This role requires an experienced professional capable of developing and executing an integrated clinical strategy in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents. Key Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: 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 biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature. Provide input on clinical development plans for Early Development or Medicine Development Teams. Contribute to the clinical and technical diligence assessment of business development opportunities, in close partnership with the VP CGT and the Business Development function as opportunities for evaluation emerge. Partner with the VP CGT to develop proposed clinical development plans for assets under business development evaluation. Line manage and/or mentor other 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; demonstrate ability to incorporate global considerations into strategic and operational decisions. Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population. Implement new business processes and standards and proactively identify potential risks and mitigation strategies in the end to end development of Oncology medicines. 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. Work closely with the Oncology Standards Team to effectively implement deliverables and assist in standardizing medical review. Contribute to program level standardization with respect to CRF designs, data entry guidelines, table/figure/listing structures and medical review tools. As the above accountabilities allow, oversee the conduct of iterative, in-stream, standardized medical data review that employs medical judgment, with intent to ensure data accurately and completely reflect the clinical course of participant(s) in the study. Participate in interpretation of data analyses of clinical trial results and support the development of clinical study reports. Participate in and/or lead Oncology Clinical Development-specific workstreams or initiatives as appropriate. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors or Master's degree 10+ years of experience in pharmaceutical industry or related clinical experience Experience with data review/interpretation, study design and the clinical development process Experience using electronic data capture (EDC) systems, query management, and medical review tools Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles Prior line management experience Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD or PharmD 15+ years of experience in pharmaceutical industry or related clinical experience 5+ years of experience in Oncology Drug Development Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes. Experience in the clinical assessment of business development opportunities to expand a growing portfolio Understands the impact of decisions and maintains awareness of business drivers and alternative solutions for project delivery. Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support. Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment. 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. 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