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Director, Clinical Development (MD) GI/AFib

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Research & Development
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184767 Requisition #
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Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

 

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

 

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

 

Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

 

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

 

We are looking for a Director with experience in GI and/or AFib to join our International Clinical Development team to act as the Clinical Science lead for their therapy area. They will be responsible and accountable for the scientific validity and integrity of the Clinical Development Plan and all clinical content, including, but not limited to: protocols, IBs/IDFUs, clinical data reviews, CSRs, regulatory submissions and publications associated with the clinical trials.  In collaboration with the CPL and Clinical Sub-team members, the CSL participates in the development of the Clinical Development Plan by contributing the scientific/clinical expertise for the strategy.  

 
Responsibilities include:
  • Medical input for study documents
  • Review of vendor documents from a medical perspective (e.g. SOW, charters, database builds)
  • Medical/safety input for ICF development/amendments
  • Review of regional ICF amendments
  • Responding to IRB questions
  • Medical oversight for CRO medical monitors (1 or more regions)
  • Oversight for medical monitor eligibility review process
  • Protocol related questions from study team and sites
  • Review of relevant lab alerts in conjunction with safety
  • CRO vendor management (not sure if this should be included but presently this is our default task)
  • Review of relevant protocol deviations
  • Clinical scientist oversight for data review
 

The CSL may present the clinical development aspects of a project and clinical trial results at internal or external meetings (e.g., with Regulatory Authorities, with external experts). The role is based in our Marlow offices with travel up to at least 30% of time, including international travel


Minimum Requirements
  • Relevant science degree (e.g., MD, PharmD, PhD);
  • Prior experience in an immunology-related field (clinical practice experience would be ideal)
  • Prior medical monitoring experience (global study experience would be ideal)
  • Experience working with cross-functional teams
  • Experience working with CRO
  • Extensive overall work experience or equivalent combination of experience and education
 
Skills and Attributes
  • Understands & leverages cross-functional roles & responsibilities to effectively & efficiently accomplish team goals
  • Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally
  • Understands and leverages cross-functional roles and responsibilities
  • Communicates effectively with internal/external stakeholders
  • Encourages ideas from others
  • Ability to make connections between organization, team, product, ideas, etc.
  • Ability to understand implications of strategic decisions
  • In-depth knowledge of industry, competitors
  • Encourages innovation and efficiency and welcomes change
  • Identifies and resolves complex problems in a solution-oriented manner
  • Meets corporate timelines
  • Ability to make tough decisions quickly
  • Demonstrates basic understanding of global pharmaceutical/ device product development environment
  • Embraces diversity of thoughts, ideas, and approaches

#LI-KR1

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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