Medical Director, Therapeutic Area Lead, Neuromuscular

2 months ago

Welwyn Garden City, Hertfordshire, United Kingdom Roche Full time
Job Summary

We are seeking a highly experienced and skilled Medical Director to lead our Clinical Development organization in the Neuromuscular therapeutic area. As a key member of our team, you will be responsible for developing and executing late-stage clinical strategies and plans that deliver medically-differentiated therapies to patients.

Key Responsibilities
  • Develop and lead the Clinical Development plan for assigned molecules/indications, ensuring strategic and operational alignment with the relevant Clinical Development strategy, strategic and annual Lifecycle Plans.
  • Collaborate with cross-functional teams to develop and implement communications strategies to support ongoing and concluded studies, including investigator meetings, KOL interactions, advisory boards, and major medical meetings.
  • Lead the design, development, and execution of clinical studies, ensuring timely completion of interim study reporting and securing data for final study reporting.
  • Represent Clinical Development in sub-teams and help ensure cross-functional integration, coordination, and alignment to enable effective and efficient Clinical Development plan execution.
  • Participate in and/or lead the Clinical Science Team, representing Clinical Development in relevant sub-teams and ensuring cross-functional integration, coordination, and alignment.
Requirements
  • Board Certified Neurologist with Neuromuscular clinical experience required.
  • Relevant clinical, scientific, or clinical trial/development experience in the same/similar therapeutic area required.
  • Academic/teaching background is a plus.
  • Significant experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
  • Experience publishing results of a scientific study in a peer-reviewed journal is preferred.
  • Significant pharma/biotech industry experience or is a recognized expert in the field.
  • Significant experience designing and conducting clinical trials.
  • Experience authoring a global development plan is preferred.
  • Understanding of Phase II – III drug development.
  • Knowledge and understanding of Phase I & IV drug development is a plus.
  • Understanding of product and safety profiles.
  • Regulatory: Knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations is required.
  • Four (4) or more years pharma/biotech industry experience or is a recognized local expert in the field.
  • Up to 30% global travel.
Preferred Qualifications
  • Experience working in a similar therapeutic area.
  • Experience with clinical trial design and execution.
  • Experience with regulatory submissions and interactions.
  • Experience with data analysis and interpretation.
  • Experience with clinical development planning and execution.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Medical Director looking for a new challenge, please submit your application.

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