Clinical Program Director

Hobson Prior are looking for a Clinical Program Director to join a leading biopharmaceutical organisation who provide pioneering medicines to patients all over the world. This role will be accountable for the clinical program strategy and operational design inputs to deliver their assigned programs as part of the product development team.

Job Responsibilities:

• Plans, directs and delivers the operational components of assigned clinical programs from design concept to final CSR, through to study closed and archived within agreed budget, time, quality and aligned KPIs.
• Responsible for providing strategic and operational input to cross-functional program development plans, data interpretation and accountable for cross-functional leadership roles as delegated from the Global Project Team.
• Leads and delivers differentiated and robust operational options for review at Investment Decision Governance interactions.
• Leads operational discussions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators.
• Provide expert clinical operational input into: Target Product Profile, Clinical Development Plan, Study Synopsis, Clinical Study Protocol, Clinical Study Report, IB, briefing documents, etc., to ensure seamless delivery of programs through effective collaboration.
• Develops and maintains effective program level risk management/mitigation plans to ensure timely delivery to quality and budget.
• Accountable for planning and leading issue escalation and resolution.
• Accountable for the acquisition of clinical trial data from internal and external sources.
• Input to the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance.
• Accountable for the quality of study delivery planning information into relevant planning systems.
• Accountable for ensuring timely compliance with company-wide governance controls (e.g. Sarbanes-Oxley Act of 2002, Delegations of Authority, study attestations, Letter of Assurance, financial system access, Clinical Trial Disclosure).

Key Skills:

• Strong strategic influencing skills; ability to influence broadly within and outside the organisation.
• Proven experience in driving operational delivery to timelines, cost and quality.
• Proven experience of leading delivery through collaboration with internal and external providers.

Requirements:

• Bachelor's degree in related discipline, preferably in medical or biological science.
• A minimum of 10 years or equivalent experience in drug development leadership experience.
• Comprehensive knowledge of the clinical and pharmaceutical drug development process.
• Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements.
• Significant experience of program management and use of project management techniques in complex projects, including resourcing and financial management.
• Significant experience and expertise in Clinical Trial methodology with a proven ability to deliver differentiated options based on a sound knowledge of operational delivery .
• Proven ability in problem solving and issues management that is solution focused.
• Excellent knowledge of ICH-GCP principles.
• 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.