Clinical Development Manager (Clinical Scientist), Cell and Gene Therapy, Oncology
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Jun 15 2021 Are you a highly motivated clinical scientist with a strong demonstration and wide breadth of oncology and clinical development experience with a focus on cell therapy? GSK is expanding its oncology portfolio and organization and we are looking for experienced professionals to help us rebuild and grow our internal expertise! It's a wonderful time to join our team because we have many opportunities to lead global studies in Phases 1-3 in the areas of immuno-oncology, cell/gene therapy and epigenetics. This role on our cell and gene therapy team could be an ideal opportunity for you to explore. This role within Global Clinical Oncology R&D will serve as a clinical science lead on global oncology studies and contribute to program level activities. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Responsible for the delivery of a delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study including leading clinical data review ongoing throughout study conduct. Responsible for the end to end of writing protocols (protocol concept to final study report) delivery. Contributor to informed consent forms development and other study related documents. Review and/or enhance the technical and scientific robustness of project level clinical development plans. May support regulatory interactions including contributing to briefing documents, presentations, addressing questions and responses. Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies. Contribute to development of end-to-end clinical development strategy. Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate. Actively partner to build relationships and collaborate with oncology aligned staff in other global functions. Responsible for cultivating strong relationships and robust communication among the clinical study/project team and GSK's Oncology Clinical Development Organization. This includes training, education, onboarding as well as problem solving in the conduct of clinical trials. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions. Accountable for study design and interpretation of study results that provide data to adequately address questions concerning efficacy/effectiveness, safety, applicability to targeted patient population, and clinical and commercial value that are consistent with the compounds' phase of development while ensuring that patient safety is of paramount concern. Ensuring regulatory requirements are incorporated through accountability for Study Team members/stakeholders, as appropriate) and regulatory reporting at the study level by providing leadership at study level to assure overall safety of the study subjects. Drive/Contributing 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. Serves as a product, protocol and project subject matter expert to support internal and external customers. Work with external experts to develop abstracts, manuscripts and study design presentations. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in life sciences or related discipline One or more year experience in clinical development Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree (e.g. MS, PhD, PharmD) Experience in a pharmaceutical industry or CRO environment in clinical development operations. Oncology clinical development experience, particularly in the area of immuno-oncology and/or cell and gene therapy. In depth knowledge of regulatory guidelines and ICH/GCP Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports. Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors Clinical development experience across all phases of development (I-IV). Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams. Excellent leadership demonstration with influencing and negotiation skills. 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *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. 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