Clinical Development Senior Manager

4 weeks ago

Dursley, Gloucestershire, United Kingdom Mundipharma Full time
About the Role

Mundipharma is seeking a highly skilled and experienced Clinical Development Senior Manager to lead the clinical development activities for our novel anti-fungal agent, rezafungin. As a key member of our team, you will be responsible for leading medical monitoring activities, providing clinical and scientific expertise, and collaborating with cross-functional teams to drive the success of our product.

Key Responsibilities
  • Medical Monitoring: Lead medical monitoring activities, including interacting with clinical trial sites, reviewing patient data, raising and responding to queries, and preparing for Data Review Committee and Data Safety Monitoring Board meetings.
  • Clinical and Scientific Expertise: Provide clinical and scientific expertise in the design, execution, and interpretation of clinical studies throughout the product lifecycle.
  • Regulatory Support: Provide scientific and clinical expertise to support regulatory submissions, including Investigator Brochures, Scientific Advice briefing documents, and responses to questions from regulatory authorities.
  • Collaboration and Communication: Work effectively with cross-functional teams, including clinical, regulatory, and commercial, to drive the success of our product.
Requirements
  • Medical Degree: Relevant medical degree (M.D.)
  • Clinical Drug Development Experience: Clinical drug development experience demonstrated within a pharmaceutical, biotech, or academic research environment.
  • Therapy Area Knowledge: Therapy area knowledge of Anti-infectives is desirable.
  • Collaborative Skills: Strong collaborative skills, able to leverage experience and knowledge within an Asset team and wider R&D, to drive decision-making and cross-functional alignment.
  • Communication Skills: Effective communication skills with the ability to influence key internal and external stakeholders.
What We Offer
  • Flexible Benefits Package: A comprehensive benefits package that includes flexible working arrangements.
  • Opportunities for Learning and Development: Opportunities for learning and development to support your career growth and professional development.
  • Collaborative Work Environment: A collaborative and inclusive work environment that values diversity and promotes a culture of innovation and excellence.

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