Company:  Confidential

Job Title: Global Clinical Leader, Corona Vaccine Program

Job Number: 25000

Location: Gaithersburg, MD

Job Description

We are seeking to recruit an MD to be the Global Clinical Lead for the Corona Vaccine Program.   The incumbent will be primarily responsible for developing an integrated clinical trial program including protocol design and medical oversight of ongoing studies.   He/she will be responsible for obtaining scientific advisory input, work with biostatisticians for phase 2 and 3 design and analyses, support regulatory interactions for product advancement, and work closely with operations to provide advice and decision making regarding medical input to achieve operational excellence.  The candidate must have demonstrated strong collaborative skills to work across various phases of clinical development.  Medical insight across a myriad of functions from discovery to manufacturing are expected.  Prior experience in a Biotech environment will be highly beneficial, as this role will be working on product development in an extremely fast paced and intense environment.  
 
The position will be located either at Gaitherburg MD or remote but with an expectation of at least one week per month to be at the corporate center (in addition to travel requirements). International travel is anticipated.

Responsibilities

  • Lead the clinical development strategy
  • Directing human clinical trials, phases I-IV, for lead candidate in development, helping to ensure all clinical development milestones are met
  • Participating in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals
  • Coordinate and develop information for reports submitted to FDA, CDC, WHO, or other government, regulatory, or partner  agencies 
  • Presentations to various external stakeholders – regulators, governing/harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders
  • Deep knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
  • Planning, reviewing and editing Clinical Study Reports
  • Providing input on the design of preclinical studies supporting clinical strategy
  • Manage key external technology partnerships
  • Other duties as assigned

Required Skills

  • MD with vaccine product development and experience across stages of clinical development
  • Minimum of 10 years’ experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of infectious diseases
  • Functional knowledge of concepts in vaccine immunology and vaccine development, preferably with experience in design and conduct of clinical trials
  • Working knowledge of clinical development pathways for vaccines in the US and EMA
  • Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program
  • Experience as safety physician
  • Evidence of effective leadership skills
  • Good verbal and written communication skills
  • Ability to work cross-functionally

 

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