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Medical Director & Clinical Development - United States  

Aduro Biotech (company)


Posted on : 03 August 2017

Project Description

 Medical Director – Clinical Development Reports Into: 
  • Chief Medical Officer Summary & Scope of Position: The Medical Director will be assigned to specific immuno-oncology projects and be responsible for reviewing and understanding the safety and toxicity profiles for the relevant products and applying this understanding to the clinical operations and development of the programs. 
  • The Medical Monitor will provide the clinical expertise to the therapeutic area and will work closely with a cross-functional team to align the clinical development plan with the overall development strategy of the relevant products 

Primary Responsibilities: 
  • Serve as the Medical Monitor (MM) for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) MM or directly with study investigators
  • Review safety data for routine medical data review, trend review, and safety signals from ongoing trials
  • Review serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with Safety Director and Regulatory Affairs to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs
  • Participate in interpretation of data analyses of clinical trial results and developing clinical trial reports
  • Provide strategic and design input for clinical trials and clinical development plans
  • Provide input/review of clinical documents, e.g. protocols, investigator’s brochures, case report form design
  • Participate in site/investigator identification and evaluation for clinical trials; conduct site engagement calls and visits
  • Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.)
  • Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources
  • Provide and enhance knowledge in the relevant therapeutic area to support global clinical development plans
  • Represent the company at scientific meetings and presentations
  • Contribute to scientific affairs by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content
  • Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
  • Develop and manage relationships with key opinion leaders for clinical programs
  • Independently maintain state of the art knowledge in the therapeutic area
  • Support business development as needed depending on expertise and experience  

  • Medical Degree, with specialization in oncology required
  • Minimum of 5 years’ experience in pharmaceutical or biotech industries preferred, or equivalent academic and clinical experience
  • Experience with clinical trial design, conduct, and medical monitoring
  • Knowledgeable and current in GCP guidelines in US and Europe
  • Be well connected within the medical and scientific community and have a proven successful track record
  • Outstanding leadership, team, presentation, written and oral skills required
  • Hands-on experience with clinical trial strategy, methods and designs
  • Collaborative and flexible in personal interactions at all levels of the company
  • Ability to work proactively and effectively, with exceptional creative problem solving skills
  • Excellent strategic planning, organizational and communication skills
  • Up to 25% travel  

About US:
  • Our company  is at the forefront of discovery, development and commercialization of breakthrough immunotherapies, alone or in combination that make transformative advances in the treatment of challenging diseases. We provide a workplace where employees excel, thrive and deliver value to patients, their families and our partners. 
  • Our company  offers a competitive salary and benefits package.