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Location:
Gaithersburg, Maryland, United States
Gothenburg, Västra Götaland County, Sweden
Cambridge, England, United Kingdom
Job reference: R-058210
Posted date: Aug. 09, 2019
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Global Head Clinical & Quantitative Pharmacology

Clinical Pharmacology & Safety Sciences

Cambridge, Gothenburg or Gaithersburg

2018 was a breakthrough year for AstraZeneca’s journey to return to growth – fuelled by the innovation and delivery from our Science Units. The new R&D structure is designed to help us build on this proud legacy of scientific contribution, and ensure we are positioned to continue to translate our innovative science into even more life-changing medicines for patients.

The new Clinical Pharmacology & Safety Sciences (CPSS) function will strengthen TA- alignment across clinical pharmacology and safety to improve patient-centric approaches in clinical development. By having a centralised preclinical and clinical bioanalysis and biomarker capability will help maximise speed, efficiency and quality.

You will lead a newly formed organisation with ~ 200 scientists. These are based across the UK, Sweden and the US (Gaithersburg, Boston, San Francisco) supporting all therapy areas of AstraZeneca including Oncology, Cardiovascular Renal and Metabolic (CVRM) diseases as well as Respiratory (RIA) across all clinical development stages including submissions and Life-Cycle Management. In addition, this new organisation including Bio-analysis function specifically focusing on therapeutic proteins and oligonucleotides as well as a Biomarker function.

You will be ultimately accountable for the strategy, execution and delivery of this organisation and the scientific clinical pharmacology content, also including quantitative assessments such as population PK, PK/PD and systems pharmacology in support of dose selection from FIH through Phase 3 and beyond. This includes the responsibility for all study reports and regulatory documents required for global market applications in all international regions.

The individual will represent Clinical Pharmacology at the Executive Safety Board (ESB) chaired by the CMO, be a member of the CPSS leadership team and will provide strategic and scientific advice to the Early Strategic Portfolio Committee (ESPC).

You will encourage excellence in project delivery, scientific leadership and novel science and technology investment across all areas. You will run budget, resources and talent development within the department. The global head will have a broad external network and champion internal and external visibility, publications and engagement with external partners, consortia and academic groups.

Key accountabilities:

  • Forming and leading a clinical pharmacology and quantitative pharmacology organisation built out of the two legacy organisations IMED and Medimmune with a new leadership team and a unifying culture.
  • Define and execute the strategy for the new organisation thereby providing leadership, mentorship and subject matter expertise.
  • Continuously provide scientific and strategic clinical pharmacology advise within and outside of Clinical & Quantitative Pharmacology at both project and portfolio level
  • Support all FIH dose selection, ongoing clinical development programs and global market applications
  • Demonstrate scientific leadership by exploring and implementing cutting edge technologies through a network of partnerships and academic collaborations ultimately resulting in project impact and high-quality scientific publications.
  • Within AstraZeneca foster and maintain positive and collaborative interaction with the therapeutic areas as well as with all other functions including data & AI, precision medicine and patient safety.
  • Represent the department in meetings with senior leaders of AstraZeneca
  • Lead, mentor and coach staff to develop their abilities to become future leaders within the organisation
  • Attract, hire and retain elite scientists
  • Establish appropriate and measurable objectives for performance and promotions of staff
  • Responsibility for the operational excellence of the organisations including budget.
  • Assure the implementation and adherence of corporate policies, GxP compliances and regulatory standards in the organisation

You will need to meet the essential qualifications and experience listed below:

  • Ph.D or equivalent, with a focus on clinical pharmacology or other related disciplines
  • Extensive experience in Clinical Pharmacology, pharmacometrics and clinical drug development, across a diverse range of therapeutic areas, including Oncology, CVRM, as well as RIA indications.
  • Highly experienced leader in building a creative organisation committed to science and patients.
  • Proven leadership of an international multisite function.
  • Experienced in global submissions for regulatory filings and in responding to global health authority questions.
  • Demonstrated a track record of leading external collaborations and partnerships.
  • A strong history of publishing in leading journals and using innovative methods of modelling
  • Success in nurturing talent and crafting a ‘great place to work’.
  • Exceptional verbal, written and presentation skills

Applications close Midnight 23rd August

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all relevant applicants for employment without discrimination on grounds of disability, gender or gender 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.

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Global Head Clinical & Quantitative Pharmacology
Scientific

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