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Oncology Research Lead
il y a 2 semaines
Innovative Medicine and Medical Technology: Building a World Where Complex Diseases Are Prevented, Treated, and Cured
We are seeking an experienced and highly skilled professional to join our team as an Associate Director, Clinical Sciences (Oncology). This role will play a vital part in driving progress in healthcare through the development, oversight, and execution of Ph I-IV clinical research trials.
About the Role:
This position reports to a more senior Clinical Project Scientist and works closely with Study Responsible Physicians, Clinical Leaders, and other Clinical Project Scientists within the Oncology Therapeutic Area Development group.
Responsibilities:
- Collaborate with Study Responsible Physicians and Clinical Leaders to review and approve clinical trial data, including adverse events, efficacy data, patient screening/eligibility evaluation, PK/PD data, coding, and other critical study endpoints.
- Draft and review protocol synopses, sections of full protocols, informed consent documents, Case Report Forms (eCRFs), and other data collection tools against draft protocols and central vendor scope of work.
- Manage the start-up and day-to-day operations of one or more global clinical studies, ensuring compliance with department safety practices, policies, and procedures.
- Partner with Cross Functional Trial Teams to mitigate issues in initiation and management of clinical trials and participate in review of Monitoring Guidelines, SET/IDMC charter, Statistical Analysis Plan, Data Management, and Safety Management Plans.
Requirements:
- Minimum of 4 years of experience in a related clinical research position, with at least part of the time spent within the pharmaceutical industry and leadership experience.
- Significant knowledge of basic scientific research, including clinical oncology research.
- High-performing and energetic individual with outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards.
- Fluent in written and spoken English with excellent oral and written communication skills.
