Director/Senior Medical Director – Clinical Drug Development

Job Description

A unique opportunity to work on first-in-class immuno-oncology molecules and lead a cross-functional team. The candidate will be a detail-oriented individual responsible for advancing the clinical trial pipeline drugs through phase 1/2 drug development. Knowledge of early development of antibodies in immuno-oncology, regulatory guidelines (including ICH, GCP), ability to multi-task, work independently, exercise sound judgment, and escalate issues are important for this role.  This position reports to the Chief Medical Officer.

  • Provide medical monitoring and pharmacovigilance (such as line listings of safety and efficacy data, review of SAE reports)
  • Lead development of regulatory documents (such as protocols, IND submissions, eCRF), filing experience
  • Lead pharmacovigilance activities, review narratives, clinical and laboratory data on an ongoing basis
  • Proven excellent medical/scientific writing skills (authoring and / or reviewing abstracts, presentations and manuscripts)
  • Lead the design of clinical trials
  • Contribute to selection of drug candidates and relevant target
  • Oversee site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits
  • Lead investigator and clinical advisory board meetings and consultant meetings
  • Develop and manage relationships with collaborators and thought leaders

Requirements

  • M.D, Pharm D
  • Board certification/eligibility and clinical experience in oncology or hematology/oncology
  • MD with at least 5 years pharmaceutical or relevant scientific/medical/clinical experience; Pharm D with at least 10 years pharmaceutical industry experience in clinical trials
  • Ability to work proactively and effectively applying creative problem-solving skills
  • Excellent strategic planning, organizational and communication skills
  • This role requires up to 30% travel in support of clinical study activities

 

 

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