Job Details

Would you like to apply your clinical development policy expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines?

Then AstraZeneca might offer your next career move!

We have an opportunity for a Senior Director Clinical Development Policies to join our Clinical Development team!

The Senior Director Clinical Development Policies is responsible for the development of best clinical practice and human subject protection policies, regulation and guidance, and addresses key clinical policy issues across the AstraZeneca’s development and business units, including management of all controlled documents and business processes areas owned by Chief Medical Office (CMO).

You will lead the Clinical Policy group and have input to the global Clinical Policy strategy and provide guidance to VP, R&D Clinical Excellence and CMO on ethical aspects with potential impact on policy and safety of people participating in clinical trials.

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. A place built on courage, curiosity and collaboration – we make bold decisions driven by patient outcomes. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

Typical Accountabilities, what you will be doing:

  • Has accountability for global clinical policies that support all pipeline and marketed products.  These policies include but are not limited to clinical trial transparency, data sharing collaborations, pre-approval access to therapy, bioethics, patient engagement among others.
  • Advises and assists CMO and / or VP, R&D Clinical Excellence on ethical and medical aspects that may have an impact on policy and the safety of people participating in clinical trials. Assist in providing relevant guidance and expertise to address identified gaps in clinical policies.
  • Inputs to the functional strategy and approves policies and procedures that contribute to this strategy. Responsible for the Clinical Policy function development, its scope of activities and future structure.
  • Contributes to development and maintenance of the R&D Process Governance Framework. Has accountability for the CMO owned Business Process Area.
  • Ensures consistency and alignment in management of procedural documentation and related training.  Collaborates with other functions & roles engaged in governance and policy / procedural processes
  • Sets  performance expectations in the assigned global policy areas against standards and targets in areas such as administration efficiency, quality and legal compliance,
  • Ensures that tactical leadership decisions are enforced in order for the business to achieve its objectives
  • Supports and enables the Clinical Development function to achieve its business objectives and comply with all relevant regulations and laws

Essential Requirements:

  • Qualified to degree level in a life science area
  • Mastery of Clinical Development area and multi-disciplinary experience (cross-functional or functional)
  • Experience in management of controlled documents within clinical development
  • Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
  • Possesses general knowledge of 1) medical monitoring; 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals. 5) Access to IMP outside of clinical trials
  • Proven ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.
  • Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally

Desirable Requirements:

  • Medical/Pharmacy degree
  • Experience in Medical Affairs and pre-approval access to Investigational Medicinal Product (IMP)
  • Experience in Patient Safety
  • Significant experience in multiple therapy areas (e.g., Oncology, Rare Diseases, Cardiovascular, Respiratory)
  • Proven ability to drive change

Location: Cambridge UK, Gaithersburg US, Gothenburg Sweden or Warsaw Poland Salary: Competitive + Excellent Benefits

So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Don’t hesitate in submitting an application today!

Where can I find out more?

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