Global Clinical Head - anti-IL-23 therapy

Are you a Clinical Research Physician looking for new opportunities? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? If you are ready to develop yourself beyond your wildest imagination- join us!

We lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do groundbreaking, outstanding work that has big impact on science and medicine.

At Late Respiratory & Immunology (Late R&I), we're driven by innovation and our dedication to make a real-life difference in patients' lives. That difference starts with you. We need people like you who share our passion for science and determination to meet patients' needs around the world.

What you'll do

As Global Clinical Head (GCH) you will have a unique opportunity to lead the global clinical development programs within Immunology. The specific asset is an anti-IL-23 p19 monoclonal antibody, and part of the rapidly growing Immunology franchise in one of the world's most respected bio-pharmaceutical companies. IL-23 is a key cytokine in the pathology of several autoimmune diseases. We are taking a personalized healthcare approach to differentiate from competitors and selectively target patients with IL-23 driven autoimmune disease. The asset is in clinical development for Crohn's disease and ulcerative colitis and as GCH, you will lead the clinical development program in these diseases, as well as evaluate the opportunity for treating patients with other IL-23 driven diseases. The role holds a significant development opportunity whilst contributing to the positive journey that AstraZeneca is on. You will report to VP and Head of Clinical Development Immunology.

You are also responsible for Medical Scientific strategies for clinical components of the Target Product Profile (TPP), Clinical Development Plan (CDP) and core labelling texts and will provide medical input into commercial activities and the scientific component of the pricing and value strategy. Within the Clinical Project Team (GPT), the GCH has accountability for the clinical, scientific and value content and delivery of the Medical Science components for the Program to time and quality. The GCH will be the clinical team's voice and representative at the Global Franchise Team that leads all aspects of the overall strategy of the asset

Typical accountabilities

* Overall clinical, scientific & value content for an assigned portion of the Program
* Support the GPT leading in rapidly implementing new processes and systems and sharing/seeking learning through their Portfolio of Projects
* Medical prioritization of clinical activities
* Single point accountable leader for the design, delivery and interpretation of clinical studies, ensuring the ethical and scientific integrity of the plans, studies and products in compliance with GCP.
* Ensure internal and external peer review of potential study/program design
* As available, provide clinical strategic input to in-licensing opportunities

Essential for the role

To be successful in the role, we believe that you hold a MD complemented by 3 years Pharmaceutical industry experience. You have experience of leading with high integrity and mentoring and motivating teams in a global matrix organization, by effective communication and encouraging excellent cross-functional collaborations. Your clinical research experience includes hands-on clinical drug development in the GI diseases and Rheumatology as well as in the Clinical - Commercial interface.

* Experience in Phase 3 program development and trial conduct, as well as NDA/BLA submissions
* Demonstrated ability to drive the development of project strategy, including accountability for project plans, timelines, progress and outcomes
* Proven experience in benefit and risk assessment and creating PRMP/ BRATs
* Proven experience of global regulatory submissions and interactions with major Health Authorities
* Proven experience of parallelly developing and delivering multiple large, complex studies (e.g., including but not limited to multinational outcome studies)
* Proven ability to coordinate and deliver Advisory Boards with international Key Opinion Leaders (KOLs)

Desirable for the role

* PhD, PharmD degree or equivalent
* Named Investigator on several clinical trials
* Experience of late phase clinical development in Immunology and/or Dermatology
* Strong peer-reviewed publication track record in specialist area



So, what's next!

Are you ready to bring excellent leadership and fresh thinking to the table? Fabulous! We have one seat available, and we hope it's yours.

We would like to know more about you. If you are interested, apply now!

Welcome with your application no later than June 14th, 2020.