Clinical Development Manager - Oncology
GSK's Projects, Clinical Platforms and Sciences group is seeking 3 Clinical Development Managers for its Oncology team. We are seeking talent who possess strong scientific and clinical research backgrounds and is able to take lead roles in the clinical science and operational responsibilities of oncology clinical trials.
The candidate will be expected to:
• Serve as a clinical and operational team leader on global and regional teams.
• Create and foster strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring and pre-Clinical Development.
• Lead the design, implementation, operations/study management, and interpretation of clinical trials.
• Lead the writing of protocols, Informed Consent Forms, clinical study reports and regulatory-related documents.
• Support the writing of subsequent regulatory briefing documents.
• Lead and accountable for study start up activities, site initiation visits, interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings.
• Ensure trials are conducted effectively, reach target enrollment, and are conducted within budget- and time-constraints, in partnership with AROs/CROs and GSK regional and in-country groups, to deliver submission-quality data.
• Demonstrate efficiencies in the areas of budget management, contracting and resourcing.
• Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.
• Work with external experts to develop abstracts, manuscripts, study/program design and presentations.
• Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
• Ability to directly manage line reports as well as serve as mentor and coach of colleagues.
• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
• Proactively generate ideas for improvements and takes actions to solve problems and achieve goals beyond what is required.
• Bachelors degree
• At least 6 years demonstrated hands-on scientific and clinical development experience
• Early phase oncology clinical development experience
• Candidate will be able to assume direct responsibility for initiating, conducting, and reporting oncology clinical studies.
• Experience in developing and writing study protocols, study procedure manuals, informed consent forms, clinical study report, and manuscripts
• Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
• Key skills include verbal and written communications, with the ability to present to internal department meetings and external advisory/investigator meetings.
• Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)
• MS, PhD or PharmD
• Oncology clinical development experience across Phase I-IV
• Proven track record of leading a clinical matrix team and working with investigators, external experts, Contract Research Organizations, Local Operating Companies, and vendors
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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