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Associate Medical Director

Position Summary:

This position will be responsible for the development of policy and thinking regarding study design and conduct as well as drafting and developing clinical development plans for all ongoing programs. This position will liaise with Head of Clinical Research, Medical Directors/Monitors, Clinical Scientists and other Development/Regulatory personnel to develop high quality clinical documents for study use and regulatory submission.

Essential Functions:

  • Act as a medical monitor for assigned product development programs, including designing and conducting clinical trials (i.e. protocol and SAP development, ongoing data review, response to IRB/MoH queries)
  • Provide direction and liaise with Clinical Operations to ensure successful execution of clinical studies
  • Clinical representative on study teams, development teams and interdepartmental meetings to discuss progression and execution of clinical programs
  • Develop, draft and/or review clinical study reports and manage the presentation of key clinical findings to internal and external constituents
  • Support critical interpretation of results of completed clinical trials for important Go/No-go decisions and in preparation for submission to relevant regulatory authorities
  • Draft and develop key documents for assigned development programs (i.e. briefing books for advisory boards or regulatory meetings, clinical development plans)
  • Lead process of annually updating product Investigator Brochures
  • Research published literature and regulatory documents related to clinical development plans, protocol development and execution and other scientific activities of the department
  • Assessment of literature and disease background for in-licensing opportunities
  • Creation of in-house medical training and investigator meeting materials
  • Conduct trainings for internal and/or external study personnel to support ongoing studies (IB, protocol, therapeutic area, etc.)
  • Organizing and participating in advisory board meetings, development of meeting materials, and in general, working with external advisors as needed to support ongoing programs
  • Assist with conceptualization, review and authoring of abstracts, posters and manuscripts to support the product publication plan, and lead effort as appropriate
  • Contribute to the scientific, clinical, and commercial development of product candidates (both internal and external), including medical and scientific input for due-diligence processes and presentation of key findings
  • Participate in mentoring fellows and junior scientists
  • Occasional technical supervision, but generally capable of designing and executing clinical protocols and trials. 
  • Recognizes and independently engages appropriate sources of needed information such as literature, colleagues, etc.
  • Can independently represent the clinical sciences department on project or program CORE development or lifecycle team.
  • Occasional travel within the United States, and overseas, will be required.

Required Experience:

  • Infectious Diseases Clinical Fellowship or/or Board Certification with relevant clinical development experience or industry equivalent

Preferred Experience:

  • Experience in infectious diseases and ideally in pediatrics.
  • Experience with late stage (e.g. Phase 2b-4) study start-up, database lock and finalization of clinical study reports and other regulatory documents recommended.
  • Experience with preparing regulatory filings and preparing for and representing the company during inspections a strong plus. 

Preferred Education:

  • MD, Pharm D or PhD with 3+ years of clinical research experience (min of 2 yrs in industry or in an ID focused fellowship).

Preferred Additional Skills:

  • Basic knowledge of clinical trial design, biostatistics, pharmacokinetics and familiarity with infectious diseases a plus.  Knowledge of GCP and regulatory requirements.  Be able to independently conduct review of literature and present in depth scientific analysis of published literature
  • Good written and oral communication. Able to work well within a team environment.
  • Able to present trial design and study results to team.  Good presenter at scientific meetings.   Author abstracts and contribute to scientific publications. Able to hold a dialogue with key leaders regarding the most current scientific and/or medical thinking.
  • Has the ability to adopt new techniques within the discipline.  With supervision, has the ability to plan and carry out clinical trials.  Has the ability to independently solve routine problems within discipline.   Exercises independent judgment to determine and recommend appropriate actions within the discipline.  Recognizes appropriate opportunities to apply skills and share clinical insight across the organization.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically and internationally.

 

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