Director / Associate Director, Clinical Scientist - Oncology

Site Name: UK - Hertfordshire - Stevenage, Baar Onyx, GSK House, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Apr 22 2024 This position will consider candidates at an Associate Director or Director level dependent on individual qualifications. Are you interested in a leadership opportunity to bring ground-breaking cancer therapies to patients by working with a team that unites science, technology, and talent? If so, this role may be for you! The Clinical Scientist will report to the Clinical Science Program Lead in Oncology Clinical Development. As a Clinical Scientist, you will be responsible for leading and/or contributing to the clinical strategy in the Clinical Development Plan and will be responsible for scientific oversight, per Good Clinical Practice, of sponsored studies in alignment with the Target Product Profile. In this role, the Clinical Scientist will serve as a clinical sciences leader on global oncology studies and contribute to program-level activities. These responsibilities include the delivery of high-quality study design, understanding the analysis and interpretation of data throughout the study, leading and/or contributing to medical data review throughout the study lifecycle, and effective collaboration and communication across a matrix team and with senior leaders and external investigators. Key Responsibilities: Serve as a clinical science leader on global oncology clinical studies and contribute to program-level activities. Lead and/or contribute to study strategy and design, understanding the analysis and interpretation of data throughout the study, including medical data review throughout study conduct. Lead and/or contributor to the end to end of writing protocols, protocol amendments, informed consent forms, study reports, scientific abstracts and manuscripts, annual reports, and regulatory submission documents, among other study related documents. Effectively collaborate and communicate with study physicians and team members across clinical operations, regulatory affairs, biostatistics, clinical programing, safety and pharmacovigilance, precision medicine, clinical imaging, medical affairs, value evidence, epidemiology, project management, quality risk management, and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials. Develop trust and partnerships with external investigators and collaborators through excellence in communication, scientific understanding, and effective presentation of GSK Oncology purpose and objectives. Develop innovative strategies and solutions that contribute to the optimal development of clinical trials per Good Clinical Practice. Contribute to Oncology Clinical Development and GSK enterprise-wide initiatives and workstreams, as appropriate. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Director level requirements: Bachelor's degree in life sciences or related discipline. Director level experience in pharmaceutical/biotechnology industry or related clinical experience. In depth experience with clinical science, study management, global regulatory guidelines, and ICH/GCP. Experience in developing and writing study protocols, informed consent forms and clinical study reports, abstracts, manuscripts, and annual reports. Experience with clinical development from early stage through to regulatory submission and market support. Experience with collaboration and influence in a clinical matrix environment. Experience working with investigators, site staff, external experts, Contract Research Organizations and vendors. Clinical development plan management experience. Associate Director requirements: Bachelor's degree in life sciences or related discipline. Experience in pharmaceutical/biotechnology industry or related clinical experience. Experience with clinical science, study management, global regulatory guidelines, and ICH/GCP. Experience in developing and writing study protocols, informed consent forms, and clinical study reports. Experience working with investigators, site staff, Contract Research Organizations, and vendors. Experience with cross functional leadership skills. Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree (e.g., MS, PhD, PharmD). Experience in Oncology Clinical Development/Clinical Science. Experience in the Pharmaceutical industry with specific experience leading a team with progressively more senior positions and responsibilities. Strong team leadership skills in matrix environments and effective communication with peers, external experts, and senior leaders. Experience managing, developing, and motivating a team to deliver clinical study results in a timely manner. Experience in setting high performance standards and measures, driving accountability throughout the function, and mentoring staff. Experience in various phases of clinical development including design and execution of dose selection, establishing a proof of concept for go/no go decisions, and registration studies. Experience in change management, restructuring, and building capabilities. Experience identifying, assessing, and understanding the needs of key decision makers and stakeholders and building effective relationships with team and senior leaders in a matrixed environment. Knowledge of safety requirements as pertains to drug development, research projects, and/or market support. Knowledge of regulatory requirements to support registration. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together. Find out more: Our approach to R&D. LI-GSK #Hybrid Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. 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