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Associate Vice President, Global Clinical Development, Ophthalmology

USA - Pennsylvania - North Wales (Upper Gwynedd)

Job Description

The Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and life-cycle management activities in the Neuroscience & Ophthalmology Therapeutic Area. The incumbent will be expected to lead multiple ophthalmology programs including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be responsible for leading Product Development Teams and guiding Clinical Directors within their group to ensure that the programs are being executed effectively according to approved strategies and plans. They will require a solid understanding of the disease area, the functions and processes relevant to drug development, and project management principles as applicable to the pharmaceutical industry.

Primary Responsibilities:

  • Under the Therapeutic Area (TA) Head, leads development for multiple Ophthalmology projects, including pipeline and licensed candidates. The Section Head may lead Product Development Teams (PDT) and manage PDT leaders and clinical directors responsible for clinical programs.

  • Supervises development of clinical documents including development plans, protocols, trial related documents, clinical study reports and background documents.

  • Interfaces with functional experts across the enterprise to ensure alignment and operational excellence in the late development of ophthalmology assets.

  • May serve as a senior therapeutic area content expert within the company, providing input into research and business development priorities and prioritization of clinical assets. 

  • May serve as the senior liaison for relevant stakeholders in the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies).

  • Models cross-functional collaboration and team leadership, coaching and inspiring PDTs to be high performing teams.

  • Responsible for managing, coaching, and mentoring Clinical Directors and developing the next-level talent pool within the Neuroscience & Ophthalmology Section.

Education Requirements:

• M.D or M.D./Ph.D.

• Board Certified in Ophthalmology

Required Experience and Skills:

  • Minimum of 8+ years’ experience in Ophthalmology clinical research. Prior industry experience strongly preferred.

  • Substantial experience bringing Ophthalmology assets through various stages of clinical development, with an emphasis on late-stage development

  • Experience with planning and execution of strategies for product registration and commercialization / life-cycle management

  • Proven ability to lead high performance cross-functional teams (e.g. Product Development Teams or similar)

  • Strong leadership skills and management experience with a proven track record of hiring, mentoring, and retaining top talent

  • Demonstrated ability to collaborate and network well within the organization; widely recognized within the organization as an expert in drug development

  • Demonstrated ability to understand and manage, with appropriate …

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