Medical Director, Oncology

4 days left

Location
Morrisville, North Carolina
Salary
salary will be commensurate with experience
Posted
Nov 14, 2018
Closes
Dec 14, 2018
Position
Medical Director
Education
MD
Hours
Full Time

Bavarian Nordic is a mid-size Biotech global organization, founded in 1994 and headquartered in Kvistgaard, Demark with locations in Munich, Germany and North Carolina.  We are looking for an M.D. who is interested in pursuing a career in Biotech or Pharma Industry, and is interested in learning about Drug Development and Clinical Research from the developer’s perspective.   

PRIMARY RESPONSIBILITIES: 

  • Responsible for the full scope of clinical strategy functions and activities including Phase I-IV clinical trial design, implementation and execution, clinical research, data analysis and management.  
  • Provide leadership and manage all clinical development according to agreed-upon deadlines and budgets  
  • Develop and execute clinical trial strategy and design working closely with VP of Clinical Strategy Oncology, Clinical Development, Medical Affairs, R&D, Regulatory and Commercial Development teams 
  • Provide strategic input and development support for clinical plans and individual study protocols: 
  • Search, compile and summarize research literature and scientific overviews to support the clinical research 
  • Prepare background summaries for clinical research and regulatory documents 
  • Collaborate with Statisticians in the design, analysis and interpretation of clinical trials  
  • Collaborate with Data Management in CRF design, data coding, listing review, etc 
  • Collaborate with Pharmacovigilance in the assessment of safety reports and potential safety signals 
  • Collaborate with Medical Writers in the elaboration of documents: clinical protocols, clinical study reports, Investigators Brochures, IND filings, Annual Reports, etc. 
  • Responsible for preparing clinical portions of INDs, new Drug Applications and Biologics License Applications, including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios 
  • Medical Monitoring, either as direct and only responsible in BN-managed studies, or overseeing responsibility over the CRO’s Medical Monitor in CRO-managed studies  
  • Establish and maintain relationships with alliance partners, external companies (such as CRO), investigators and opinion leaders to optimize performance on clinical trial activities 
  • Prepare abstracts, manuscripts and slide presentations for external scientific meetings and for internal communications 

Requirements for Position:

  • MD required  
  • Oncology training required (including Residency and/or Fellowship experience)  
  • Experience in clinical research is desired  
  • Immunology knowledge or experience is desired  
  • Must be willing to work in the BN office (Morrisville, NC)  

Knowledge & Skills Required:

  • Excellent analytical and strategic planning skills
  • Must have leadership experience in a high growth environment and the ability to delegate tasks as appropriate 
  • Proven organizational and project management skills and ability to handle multiple diverse projects simultaneously 
  • Strong interpersonal, oral and written communication skills, including the ability to effectively communicate with all levels of personal  
  • Ability to work accurately with close attention to detail
  • Work proactively and effectively in a fast-paced environment
  • Ability to adapt to changes in company structure and responsibilities
  • High level of personal integrity, excellent work ethics and respect for colleagues at all levels 
  • Ability to travel domestically and internationally