Director Study Leader, Early Oncology Clinical

The Director Study Leader, Early Oncology Clinical is responsible for delivering a single or several smaller development programs or leading multiple studies or single complex/novel studies such as platform, basket, etc. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility and autonomy is required.

The Director Study Leader may provide expert input to other non-drug programs and improvement projects.

**Typical Accountabilities**
- Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documents
- With oversight from the Senior Director Clinical Programs, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
- Leads the delivery of the clinical study program(s) or study(s) from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standards
- Accountable for overall study or program deliverables, maintaining oversight by close interaction with individual study leaders or leadership of the study team as appropriate
- Implement agreed study level process and technology for Early Oncology clinical studies
- 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
- Provide input to forecasting and management of study delivery costs, resource and timelines
- Accountable for the quality of study planning information into relevant planning systems (e.g.: IMPACT, PLANIT)
- Guide the study team in the development of outsourcing specifications and vendor selection
- Provision to procurement clear specifications for study or program specific outsourcing
- Review and operational approval of study or program specific contracts or work orders
- Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
- Communicate study level reports and status updates for Early Oncology clinical studies
- Lead and conduct investigator meetings and other study related meetings
- Identify and communicate resource gaps for assigned studies
- Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
- Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
- Mentors and supports development of individuals within the organisation
- Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators

**Education, Qualifications, Skills and Experience**

**Essential**:

- Bachelor’s degree in related discipline, preferably in medical or biological science
- At least 10 years drug development experience demonstrated in a variety of roles
- At least 5 years of 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.
- Project Management experience within the context of Clinical Drug Development
- 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
- Ability/willingness to lead strategic and/or operational management of individual clinical trials should the need arise
- 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 clinical delivery

**Desirable**:

- Higher degree e.g. PhD, MSc, MPhil
- Programme management qualification (e.g. MBA, PRINCE2)
- Experience in variety of academic/CRO/Sponsor organisations and countries
- Early oncology clinical delivery

**Key Relationships to reach solutions**

**Internal**:

- 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

**External**:

- Strong external awareness and contacts
- Investigators
- Credibility with