Director Study Leader, Early Oncology Clinical

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

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

  • (Bf874) Director Study Leader, Early Oncology Clinical

    hace 1 semana

    Barcelona, España Empresa Reconocida A tiempo completo

    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...

  • (Bf874) Director Study Leader, Early Oncology Clinical

    hace 1 semana

    Barcelona, España Empresa Reconocida A tiempo completo

    .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...

  • (Bf874) Director Study Leader, Early Oncology Clinical

    hace 1 semana

    Barcelona, España Empresa Reconocida A tiempo completo

    .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...

  • Director Study Leader, Early Oncology

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    **Role Description** 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...

  • (Bf874) Director Study Leader, Early Oncology Clinical

    hace 1 semana

    Barcelona, España Empresa Reconocida A tiempo completo

    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...

  • Mj742 - (Bf874) Director Study Leader, Early Oncology Clinical

    hace 1 semana

    Barcelona, España Ares Consultores A tiempo completo

    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...

  • Mj742 - (Bf874) Director Study Leader, Early Oncology Clinical

    hace 1 semana

    Barcelona, España Ares Consultores A tiempo completo

    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...

  • Director Study Leader, Early Oncology

    hace 1 semana

    Barcelona, España Importante Empresa Del Sector A tiempo completo

    Role DescriptionThe 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...

  • Director Study Leader, Early Oncology

    hace 1 semana

    Barcelona, España Importante Empresa Del Sector A tiempo completo

    Role DescriptionThe 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...

  • Group Director Study Operations

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Are you excited about Clinical Development and **Study Operations? **Would you like have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us!! **About AstraZeneca** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and...

  • Senior Clinical Operations Leader for Early Oncology Development

    hace 4 semanas

    Barcelona, Barcelona, España Empresa Reconocida A tiempo completo

    Job Summary">We are seeking an experienced Senior Clinical Operations Leader to lead the delivery of clinical development programs in Early Oncology. The successful candidate will be responsible for delivering a single or multiple smaller development programs, leading multiple studies or complex/novel studies such as platform and basket trials.">Key...

  • Executive Medical Director, Early Clin Dev Oncology

    hace 4 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Follow the science to pioneer new frontiers!** Join the team at the heart of AstraZeneca that is committed and encouraged to follow the science. Driven by our curiosity, passion, and determination we are paving the way to change the practice of medicine in Oncology. As leaders of Clinical Development in Oncology, we push the boundaries of science to...

  • Director Clinical Scientist, Oncology R&d, Early

    hace 8 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Job Title: Director Clinical Scientist, Oncology R&D, Early Clinical**: **Location: Barcelona, Spain** As a Director Clinical Scientist, you will be a key member of the Clinical Development Project Team, working collaboratively with the program and study-level clinical lead/study physician as the expert in medical scientific aspects of a compound(s) and...

  • Director Clinical Scientist

    hace 1 hora

    Barcelona, España AstraZeneca A tiempo completo

    **Director Clinical Scientist - Hematology Early Oncology R&D*** **Locations flexible: US: San Francisco, CA Gaithersburg, MD, Waltham, MA** **Barcelona, Spain or Mississauga, CN** Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits...

  • Director Scientist, Oncology R&d, Early Clinical

    hace 5 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (On-site). 3 days working from the office and 2 days working from home.** **Role Description** The Director Scientist is an important part of the Project Team, working synergistically with program and study level clinical lead/study physician as the expert in medical scientific aspects of the compound and its development. The...

  • Clinical Study Operations Leader

    hace 6 días

    Barcelona, Barcelona, España Jordan Martorell S.L. A tiempo completo

    Company OverviewTFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.Job DescriptionThe Evidence Delivery Director will be...

  • Early Clinical Development, Medical Director

    hace 7 meses

    Barcelona, España AstraZeneca A tiempo completo

    At AstraZeneca when we see an opportunity for change, we seize it and commit real resources to make it happen, because an opportunity, no matter how small, can be the start of something big. Delivering life-changing medicine is about being entrepreneurial - finding those moments and recognizing their potential. Big success can come from seeing potential in...

  • Clinical Study Delivery Director

    hace 4 semanas

    Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

    About Tfs HealthscienceTfs Healthscience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We offer full-service capabilities, resourcing, and functional service (FSP) solutions.Job SummaryThe Evidence Delivery Senior Director...

  • Senior Director Clinical Program

    hace 3 meses

    Barcelona, España Astrazeneca A tiempo completo

    .Join us at AstraZeneca as a Senior Director Clinical Program (SDCP) in our Oncology R&D department!This role is accountable for the clinical program strategy and operational design inputs to deliver assigned programs.As a key leadership member of the Global Project Team, you will engage with and influence collaborators both within and outside of...

  • Director, Precision Medicine

    hace 3 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Are you excited about **Precision Medicine**? Would you like have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us! We’re investing like never before in our people, in growth, and in new diagnostic techniques and technologies. There are opportunities at every turn, with a variety and breadth that is...