Clinical Sciences Trial Leader

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Summary

As a Clinical Trial Leader you will be leading the global multidisciplinary matrix Clinical Trial Team (CTT) to ensure all trial deliverables are met. You will be responsible for the availability of high quality, Biomedical Research data according to agreed timelines and budget to enable no delays in strategic decision making and drug registration.

Summary

As a Clinical Trial Leader you will be leading the global multidisciplinary matrix Clinical Trial Team (CTT) to ensure all trial deliverables are met. You will be responsible for the availability of high quality, Biomedical Research data according to agreed timelines and budget to enable no delays in strategic decision making and drug registration.

This is a hybrid role – there is a requirement to be on site in the Westworks London office three days a week. We are unable to offer permit support for this role.

We have the option to hire someone at Senior Clinical Trial Leader if this role level is a better match to the experience and skill set of the applicant.

About

The Role

Major accountabilities:

• Study Leader and/or Clinical Scientist for predominantly low complexity, global studies and may provide additional Clinical Sciences support to high complexity, global studies.
• Lead or support the clinical protocol development process in collaboration with the Medical Lead and other line functions; responsible author for clinical protocols, amendments, etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which resides in other line functions; contribute to the development of clinical sections of study-level regulatory documents.
• Support development of strategic and scientific input into study concept, feasibility, and ability to execute; develops and implements study-level operational execution plan in partnership with key cross functional partners, if applicable.
• Collaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met.
• Lead or support a global cross functional CTT to ensure all trial deliverables are met; sets stretch goals, promotes realistic planning and timelines, and presents actionable alternatives to accelerate timelines.
• Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations.
• Lead or support the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions, and partners on data analysis and data interpretation, including safety trend analysis, signal detection, development of first interpretable results, reporting clinical study results in CSR, and internal/external publications.
• Prepare, lead or support dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, to provide consolidated information for dose escalation meetings and Phase II data reviews with relevant stakeholders.

• Bachelors in life science/healthcare required;
  Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/PharmD/ Masters).
• Approximately 2+ years’ experience in clinical trials/development
• Fluent English (oral and written)
• For TCO:
  Strong understanding of oncology/hematology and demonstrates high learning agility.
• For TM:
  Demonstrates high learning agility.
• Demonstrated ability to drive collaborations through unpredictable circumstances and higher paced changes.
• Demo…