The Medical Director of Clinical Development for Neurology - Belfair, United States - Cascade Innovations

Cascade Innovations
Cascade Innovations
Verified Company
Belfair, United States

3 weeks ago

Meredith Sinclair

Posted by:

Meredith Sinclair

beBee Recruiter
Description

Location: Belfair

About the Job

ARTO is currently partnered with a global biotech company who is focused on developing multiple assets in the field of Neurology. They specialize in small molecule therapies for chronic inflammatory and autoimmune diseases. As they approach phase III with their lead asset, they are looking to expand their Medical team by hiring a (senior) Medical Director, Clinical Development.

Medical Director, Neurology,

The Role:

  • Developing and implementing the clinical development plan and strategy, while also providing medical input for development
  • Leading the preparation and completion of regulatory submission documents (NDA, IND) from submission to approval
  • Authoring and reviewing protocols, safety data, and clinical study reports
  • Providing Medical Expertise in meetings with regulatory agencies, advisory boards, and external medical experts
  • Demonstrated experience in medical monitoring and data cleaning in clinical research or related industry

Experience:

  • Preferred: Medical Doctor with a specialization in Neurology or neuro-inflammatory diseases
  • 5-10 years of experience in clinical drug development, from phase I to phase III, including leading initial study design, study execution, and regulatory submissions (INDs, NDAs)
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