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Location:
Gaithersburg, Maryland, United States
Waltham, Massachusetts, United States
Job reference: R-045847
Posted date: Feb. 28, 2019
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At AstraZeneca, we win through the science, it’s at the heart of our every success.Every decision is rooted in the limitless possibilities of what science can do. We focus our science in the areas of Oncology, Respiratory, CVRM and INA.

We push the boundaries of science to deliver life-changing medicines.This purpose underpins everything we do.It gives us a reason to come to work every day. It reminds us why we exist as a company. It helps us deliver benefits to patients and create value for shareholders. It also sets the context for our employees’ activities and the roles of our teams, partners and other collaborators.

AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

At AstraZeneca, we are committed to advancing the science of oncology to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of four scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Anti-body-drug Conjugates) to help address unmet clinical needs in a host of cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death.There are many types of cancer disease. For us to be most effective, we've chosen to concentrate on four key disease areas; Lung Cancer, Breast Cancer, Ovarian Cancer and Haematology.

We currently have nearly 100 Phase 1, 2, 3 and Lifecycle Management Oncology projects in our robust pipeline.

We deliver the Research & Development for Oncology through our newly created Oncology R&D Unit.This unit has responsibility for the value chain from discovery through to late-stage development, enabling rapid acceleration of promising early-stage assets and life-cycle management programs.

Position Summary:

We are seeking a well-trained clinician with strong leadership skills who is driven by science and the desire to develop novel Immuno-Oncology therapies for cancer patients, and who has a mastery of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.This individual will have the opportunity for growth and development while working in a vibrant environment and “biotech” culture.

Senior Director, Clinical Development, Oncology will be based in Gaithersburg, Maryland and will report to the Vice President, Clinical Development, Immuno-Oncology. Other responsibilities include;

  • Leading a team of Clinical Development professionals responsible for delivering against Immuno-Oncology Drug Development projects.
  • Full responsibility for the planning, implementation and daily operation of a drug development projects, including a focus in the ACT and T-Cells.
  • Collaborate with key internal and external stakeholders and may serve as the project Medical Monitor.
  • Contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
  • Specific duties and major responsibilities include:
  • Direct/Oversee the design and implementation of early stage clinical projects, as a member of our Product Development Team (PDT) and leader of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
  • Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.
  • Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan.
  • Present and defend protocols and clinical development plans at internal governance forums.
  • Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II studies, managing the process from protocol development thorough individual study report and integrated regulatory documentation.
  • Provide oversight and guidance to clinical team activities at the Product Development Team, Clinical Study Team, Clinical Trial Team, and Translational Science Sub-Team.
  • Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
  • Present study updates, interim results, and final headline data to senior management as required.
  • Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
  • Ensure that Serious Adverse Events are properly reported on a global basis.
  • Lead cross-functional teams comprised of multidisciplinary professionals and clinical scientists.Direct responsibility for leading a team of Clinical Development professionals and ensure delivery of their portfolio of assets.
  • Implement clinical R&D policies, SOPs and related directives.
  • Review potential in-licensing candidates and present recommendations to Senior Management groups.
  • Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
  • Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.

Education:

  • MD with a valid medical license required
  • Medical specialty and sub-specialty training and certification are required in Oncology.

Experience:

  • Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or hematology is required.
  • Immuno-therapy experience preferred.Areas of concentration should include ACT/T-Cell experience desirable.
  • Director- At least 2-5 years of experience in clinical research and/or Oncology drug development in pharmaceutical or CRO environment.
  • Senior Director- At least 5 plus years’ experience in clinical research and/or Oncology drug development in pharmaceutical or CRO environment.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.  AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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Senior Director, Clinical Development, Oncology – Physician
MedImmune

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