Job Detail

Assoc Director, Clinical Trials Management

Req ID: 17840
Job Category: Regulatory Affairs

Location: Zurich, Zurich

Posting Date: January 28, 2020

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Associate Director, Clinical Trial Operations, Global Regulatory Affairs

Location: Zürich, Switzerland or Boston, USA

Position Summary

The Associate Director, Clinical Trial Operations, Regulatory Affairs will be responsible for developing and implementing strategies to optimise regulatory aspects of clinical trial management across the Alexion product portfolio. This individual will lead development and implementation of Alexion Global Regulatory Affairs (GRA) processes to support worldwide clinical trial execution.

Principal Responsibilities

Oversight for Alexion GRA clinical trial management including:

• Development and implementation of streamlined processes, including Standard Operation Procedure maintenance, in relation to clinical trial regulatory management.


• Selection and management of CROs to support Alexion clinical regulatory activities. Development and communication of best practices for engaging CRO regulatory staff through all stages of development.


• Ensuring harmonization of processes for clinical trial regulatory activities across Alexion portfolio


• Development and implementation of tools to share learning experiences and to increase Alexion expertise in conducting clinical trials for rare diseases, including medical device combination products.


• Engagement with Alexion Clinical Operations leadership on topics related to operational governance of clinical trial execution across the product portfolio.


• Overall compliance management of Trial Master File regulatory components and continued support of Inspection Readiness activities related to clinical trial execution.


• Representation of regulatory function in GCP inspections across portfolio


• Maintenance of overall schedules for clinical trial applications across the Alexion development and approved product portfolio and development of efficient strategies to optimize time to regulatory approvals of clinical trials


• Leading the implementation of the European Clinical Trial Regulation at Alexion. This will involve participation in regulatory intelligence, process planning and formalization through cooperation with stakeholders across multiple functions, cross-functional change management and training.
   
  Qualifications

• Strongknowledge of drug development and clinical trial execution; excellent scientific and business judgment.


• Experience in regulatory aspects of clinical trial approval processes and development and submission of global clinical trial authorization applications.


• Experience of managing external clinical research organization (CRO) partnerships. Experience of working in a CRO would be advantageous.


• Track record of delivering process improvements in a complex matrix team environment. 


• Strong interpersonal, and written/verbal communication skills.


• Highly conversant and knowledgeable of relevant existing and new/emerging regulations and guidances. Detailed understanding of GCP regulations as applied to regulatory submission and clinical trial compliance.
   
  Education

• Bachelor’s Degree in a related discipline     


• 7 years in pharmaceutical industry regulatory affairs

Competencies

• Ensures Accountability


• Collaborates


• Decision Quality


• Cultivates Innovation


• Being Resilient


• Learning and Self-Development

Zurich, Switzerland

Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes’ list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.