Director of Clinical Development, Immuno-Oncology - Gaithersburg, MD | Biospace
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Director of Clinical Development, Immuno-Oncology

AstraZeneca Pharmaceuticals LP

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                                       Location:Gaithersburg, Maryland, United States
Job reference: R-006773

Posted date: May. 01, 2017



   At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Clinical Scientist, Oncology you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.  


   AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.  


   Main Duties and Responsibilities  


   We’re currently seeking a Director of Clinical Development, Immuno-Oncology to join our Clinical Operations Team. The Clinical Operations function is the organizational home for the operational delivery and also program and project management of clinical projects. The therapeutic area based departments manage both drug and non-drug projects as part of the overall portfolio delivery. This is a key leadership role within the Clinical Program Team, responsible for program management of the clinical elements of drug development. In this role, you will drive the clinical development program and also integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with Global Medicines Development (GMD) priorities and strategy. You will bring product knowledge and strategic thinking to define the value of drug programs including delivery of program of studies, clinical components to submissions, publications, maintenance support for regulatory interactions and to clinical cross functional teams.  


   As a Director of Clinical Development, you will be responsible for efficient and effective program management of all GMD clinical development deliverables, including delivery of CPT driven program/studies, clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports, clinical contributions to inspection readiness, governance interactions. As the most senior clinical operations leader, you will be accountable for oversight of all clinical operations activities within the program and for ensuring provision of clinical operations expertise/input into the program, acting as the initial and program-level AZ operational interface with externally managed/outsourced partners for program planning of outsourced studies. You will identify and resolves issues within the clinical program including the escalation of the issue to the appropriate individual/functional group for resolution and in collaboration with the Global Clinical Leader (GCL), provides strategic and operational leadership within the program and cross-functional GMD environment.  You will be responsible for ensuring timely compliance with companywide governance controls, for cross functional leadership roles as delegated from the, and for leadership and program management of non-drug project work as assigned.  


   Essential Requirements  

  •      Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred    
  •      A minimum of 10 years’ global drug development leadership or equivalent leadership experience demonstrated in a variety of roles. Experience across the product life cycle with extensive experience in late stage development (including regulatory submissions) and ideally across multiple therapeutic areas.    
  •      Experience in the oncology therapeutic area    
  •      Comprehensive knowledge of the clinical and pharmaceutical drug development process    
  •      Extensive clinical operations expertise    
  •      Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements    
  •      Significant experience of program management and use of project management techniques in complex projects, including resourcing and financial management    
  •      Proven ability to develop successful collaborations with external partners as well as with colleagues in Japan and China to ensure delivery of global programs to meet business needs    
  •      Strong strategic influencing skills; ability to influence broadly within and outside the organization    
  •      Excellent written and verbal communication skills    
  •      Proven teamwork and ability to work collaboratively across a wide range of disciplines    
  •      Track record of planning and delivery success    
  •      Proven experience in leading teams through change    
  •      Experience of and insight into the Clinical environment to be able to drive major improvement programs    
  •      Willingness to travel both domestically and internationally    

   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.