- Permanent, Full Time
- Closes 6th June 2018
- Requisition ID: WD156729
- Required degrees: Bachelors
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.
• Bachelor’s degree
• 3 years of demonstrated, hands-on scientific and clinical development experience
• Early phase oncology clinical development experience
• Experience in developing and writing study protocols, study procedure manuals, informed consent forms, clinical study report, and manuscripts
• 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. Candidate will be able to assume direct responsibility for initiating, conducting, and reporting oncology clinical studies.
• Proven track record of leading a clinical matrix team and working with investigators, external experts, Contract Research Organizations, Local Operating Companies, and vendors
• 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.
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
We want to help people do more, feel better, live longer
We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time.
As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.
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