Clinical Sciences Trial Leader, Translational Medicine

Job Description Summary

The Clinical Sciences Trial Leader contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing

#LI-Hybrid
Internal Title: Clinical Sciences Trial Leader
Location: Cambridge

 

Job Description

Key Responsibilities:

• 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 reside 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.

• Proactively lead or support risk mitigation discussions, risk management and implementation at the trial level.

• Responsible and accountable for forecasting and managing overall study budget(s) in collaboration with key partners.

• Collaborate with key partners to set vendor strategy and timelines for assigned studies.

• Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. Represent group on initiatives; may serve as Subject Matter Expert.

• Contribute to talent and career development of staff. In collaboration with the relevant manager, contributes to hiring/interview/onboarding and mentoring process for new hires.

Essential Requirements:

• Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/PharmD/ Masters).

• 1+ years’ highly relevant experience within pharma clinical trial management/operations and demonstrated accountability in leading clinical trial aspects, coupled with a good knowledge of the drug development field.

• Proficient in clinical trial methodology with an emphasis in early clinical development. Operational project management experience including excellent planning, prioritization, problem solving and organizational skills.

• Track record of successfully managing multiple clinical trials concurrently. Used to managing multiple priorities.

• Demonstrated capability to interpret, discuss and represent trial level data.

• Working knowledge of clinical finance principles to manage efficient expenditure to minimize variance between actual and forecasted spend.

• Maintain good knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies.

Desirable Requirements:

• Pharm D highly desirable

• 1+ year experience in early phase clinical trial operations preferred.

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