Study Lead - Associate Director

Hobson Prior are looking for a Study Lead - Associate Director to join a leading biopharmaceutical organisation who provide pioneering medicines to patients all over the world. This position will provide expert clinical operational input into project or study level documents (e.g clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documents).

Job Responsibilities:

• Leads the delivery of the clinical study's or programs from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards.
• With oversight from the Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions.
• Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate.
• Ensure sponsor oversight throughout the life of the study.
• Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriate.
• Responsible for planning and leading issue escalation and resolution.
• You will provide input to forecasting and management of study/program delivery costs, resource and timelines.
• Accountable for the quality of study/program planning information into relevant planning systems.
• Mentors and supports development of individuals within the organisation.

Key Skills:

• Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict.
• Proven ability in problem solving and issues management that is solution focused.
• Ability to lead strategic and/or operational management of individual clinical trials.

Requirements:

• Bachelor's degree in related discipline, preferably in medical or biological science.
• A minimum of 10 years drug development experience demonstrated in a variety of roles.
• A minimum of 5 years experience in leading studies/programs in clinical development.
• Comprehensive knowledge of the clinical and pharmaceutical drug development process.
• Extensive and proven experience in driving operational delivery to timelines, cost and quality.
• Proven experience leading delivery through internal and external organizations.
• Excellent knowledge of ICH-GCP principles.
• Project Management experience within the context of Clinical Drug Development.
• Experience and strength in working and leading in matrix teams.
• Experience in providing clear requirements for external contracts.
• Experience in selection of external providers and development/review of contracts.
• Proven oversight of external providers.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.