Associate Director, Study Leader (Early Development, Oncology)

Associate Director, Early Development Oncology Clinical Trials – UK – Home–based

Here in the ICON FSP team, we've entered into a partnership to supply a full–time, permanent home–based UK–based Associate Director Clinical Study Leader to manage the client s Phase 1 Oncology portfolio of clinical studies.

The successful applicant should have >2–3 years of running/leading Oncology Global Trials, rather than just Oncology trials experience at a Project Management level. Indeed, you must be able to demonstrate accountability for the trials, gained ideally with Pharmaceutical and CRO experience.

This is a new role for the partnership, though you will be joining an existing team of dynamic and experienced ICON staff, working on a portfolio of engaging clinical studies where you will be working with a top–10 multinational pharmaceutical and biopharmaceutical company.

Detailed Description;

The Associate Director Study Leader, Early Oncology Clinical is responsible for the delivery of clinical studies including quality, timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines. Provides matrix management of functional area representatives to cross functional clinical study teams. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required.

Typical Accountabilities

• Leads the delivery of the clinical study from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standards

• May convene and lead the cross functional study team(s) for Early Oncology Clinical studies based on delivery model

• Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate manager or CRO representative

• Contribute to preparation and delivery of study documents (e.g. Protocols/amendments, Informed Consent Form (ICF) documents detailing study delivery data management activities, etc.)

• Responsible for forecasting and day–to–day management of study timelines, budget, materials and detailed study level plans and feasibility assessment

• Leads study recruitment and data delivery to agreed timelines and targets

• Implement agreed study level process and technology for Early Oncology clinical studies

• Manage to the agreed study timelines, budget, and resource and ensure the update of appropriate systems

• Accountable for the quality of study planning information into relevant planning systems

• Guide the study team in the development of outsourcing specifications and vendor selection

• May manage the vendor(s) throughout the life of assigned clinical trial(s) based on delivery model

• Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs

• Lead and conduct investigator meetings and other study related meetings

• Identify and communicate resource gaps for assigned studies

• Communicate study level reports and status updates for Early Oncology clinical studies

• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance

• Oversee the submission of trial–related and essential documents to the Trial Master File, maintenance and final closeout of TMF

• Ensure sponsor oversight throughout the life of the study

• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness

• Responsible for study level reporting of progress, risks and issues

• Provision to procurement clear specifications for study specific outsourcing

• Review and operational approval of study specific contracts or work orders

Education, Qualifications, Skills and Experience

Essential

• Bachelor s degree in related discipline, preferably in medical or biological science

• Minimum of 5 –7 years progressive experience in clinical research, with at least 3 years of global study leadership or equivalent

• Comprehensive knowledge of the clinical and pharmaceutical drug development process

• Excellent knowledge of ICH–GCP principles

• Extensive and proven experience in driving operational delivery to timelines, cost and quality

• Proven experience leading delivery through internal and external organizations

• Experience and strength in working and leading in matrix teams

• 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

• Experience in providing clear requirements for external contracts

• Experience in selection of external providers and development/review of contracts

• Proven oversight of external providers

• Experience of early phase oncology clinical delivery

Desirable

• Higher degree e.g. PhD, MSc, MPhil

• Program management qualification (e.g. MBA, PRINCE2, PMP)

• Experience in variety of academic/CRO/Sponsor organisations and countries

Key Relationships to reach solutions

Reports to: Senior Group Director Clinical Programs

Other key internal relationships:

Medical Science Directors/Study Physicians

Project Leaders

Directors Early Oncology Clinical

Pharmaceutical Development

Study Operations

Regulatory and Patient Safety

Translational Scientists

Precision Medicine

Genomics

Compliance colleagues

Finance

Procurement

Alliance leads

Please apply today to discuss more details over an informal telephone at your convenience.