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Global Medical Director

Job description

BioTalent are delighted to partner with an exciting European biotech client looking to hire a global medical director to join their small, growing U.S team.

Reporting to the Vice President, Clinical Development your responsibilities would include:

  • Leading the development of clinical sections of trial and program level regulatory documents
  • Serve as clinical lead within the clinical trial team and implement clinical development strategy in accordance to regulatory guidelines
  • Work to support program safety, working in collaboration with patient safety colleagues
  • Provide medical input to the clinical development plan
  • Contribute to the development of biomarker strategies and support pre-clinical development activities

 

Ideally, you will have:

 

  • either an MD, MD Ph.D.or Ph.D
  • Over 3 years dedicated experience in a pharma or biotech environment with biologics/ADC experience advantageous
  • Prior experience working as part of a team working on global Phase I-IV trials
  • Strong working knowledge of oncology and ability to interpret, discuss and present efficacy & safety data
  • Broad understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes such as IND, CTA and BLA/NDA filings
  • Strong familiarity relevant FDA and EMA regulations
  • Proven ability to establish effective scientific partnerships with key partners and in KOL management managing
  • Experience in generating publications

Get in touch with Ella Jobson for a confidential discussion on +1 424 2773748 / ella.jobson@biotalent.com or click apply