Senior Director, Clinical Development - Antibacterials, Antifungals, Cmv & Covid 19

Merck Merck · Pharma · PA

Senior Director role focused on clinical development and research strategy for anti-infective drugs, including protocol development, medical monitoring, and analysis of study data. Requires MD or equivalent with infectious disease expertise and significant industry experience in clinical research.

What you'd actually do

  1. primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving investigational or marketed drugs in the infectious diseases therapeutic area.
  2. participate in all phases of the clinical trial process (mainly Phase 2-3) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication.
  3. apply an in-depth understanding of the disease under study and drug pharmacology to the infectious disease therapeutic area’s clinical development strategy and the implementation of short- and long-term research objectives.
  4. provide internal scientific leadership for cross-functional areas supporting clinical development and external leadership through interaction with key scientific leaders.
  5. Maintaining awareness of scientific developments within their area of expertise, including new scientific findings and research methodologies

Skills

Required

  • M.D or M.D./Ph.D preferably with demonstrated expertise in infectious diseases
  • PharmD degree and demonstrated expertise in clinical practice or clinical research may also be considered
  • Industry experience in clinical research and drug development (at least 5 years)
  • Demonstrated success in overseeing clinical studies and protocols
  • Demonstrated record of scientific scholarship and achievement
  • Experience in clinical medicine
  • Excellent communication skills, both verbal and written
  • Strong interpersonal skills, as well as the ability to function in a team environment and leadership experience
  • Clinical Development
  • Clinical Judgment
  • Clinical Medicine
  • Clinical Research Management
  • Clinical Trial Compliance
  • Clinical Trial Development
  • Clinical Trials
  • Data Analysis
  • Decision Making
  • Drug Development
  • Ethical Standards
  • Infectious Disease
  • Infectious Disease Research
  • Intellectual Curiosity
  • Interdisciplinary Problem Solving
  • Medical Research
  • Mentorship
  • Protocol Development
  • Regulatory Compliance
  • Regulatory Reporting
  • Scientific Consulting
  • Scientific Publications
  • Strategic Planning
  • Vaccinology
  • Veterinary Medicine

Nice to have

  • Background in infectious diseases clinical research and drug development
  • Prior experience with registrational trials and filing with major health authorities

What the JD emphasized

  • demonstrated expertise in infectious diseases
  • at least 5 years
  • Demonstrated success in overseeing clinical studies and protocols
  • Demonstrated record of scientific scholarship and achievement
  • Background in infectious diseases clinical research and drug development
  • Prior experience with registrational trials and filing with major health authorities