This role has extensive scope and full responsibility and is an essential role for my client, this assignment will see you provide expertise and input within the product dev team as well as other non-assigned drug programs, ensuring processes and improvements / workstreams are as optimal as possible
Key responsibilities include:
- Working closely with the Medical Science Director, the CPD is responsible for the full clinical program strategy, including managing all approaches to delivery (including new platforms) & technology to ensure patient engagement, recruitment and retention.
- You will be expected to plan, direct and deliver the overall operational components of your clinical programs from concept to completion to study closed and archived within all parameters set.
- You will lead and deliver individual and robust operationa formats for review at Investment Decision Governance interactions.
- It is essential that you take a lead in all operational discussions with external stakeholders
- You will be responsible for providing strategic and operational input to all cross-functional program development plans, data interpretation and responsible for cross-functional leadership roles as delegated from the Global Project Team.
- You will provide expert clinical operational input into TPP, CDP, Study Synopsis, CSP, CSR, IB and other documents ensuring the seamless delivery of programs through effective collaboration.
- You will develop and maintain effective program level risk management to ensure timely delivery to quality and budget
- You will be accountable for all facets of
- Planning and leading issue escalation and resolution
- Acquisition of clinical trial data from internal and external sources
- Overall quality of study delivery planning information into relevant systems
- Overall compliance controls & governance
- Coordination & selection of external providers
- Overall operations management and oversight of external providers at program/study level
Skills, Qualifications and Experience required
- Relevant Bachelors degree essential, advanced degree desirable
- Minimum 10 years experience in drug development leadership
- Exceptional knowledge of clinical and pharma drug development processes / as well as strongly knowledgable in cliical trial methodology with a track record of delivery of differentiated options)
- Proven ability to develop programs to meet business needs
- Very strong program management experience (including knowledge of techniques)
- Strong problem solving ability, excellent attention to detail, excellent leader and multi-tasker
- Proven experience leading delivery through internal and external organisations
- Excellent collaborative communication skills
- Exceptional knowledge of ICH-GCP principles
This is a fantastic opportunity which is a critical hire for my client, please send your CV and a cover letter to be considered for the role. Please allow 24 hours or 1 working day for me to review.
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