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Associate Director/Director, Medical Monitor

Luye Pharma USA Ltd.
Princeton, NJ
  • Posted: January 30, 2023
  • Full-Time

Responsibilities

  • Lead design and implementation of one or more clinical development programs and provide strategic and operational guidance to teams, based on medical and scientific expertise and sound clinical judgment
  • Lead development of clinical sections of study/program level documents (e.g., clinical synopsis, protocols and amendments, Investigator’s Brochures, safety updates, submission dossiers, and responses to Health Authorities)
  • Medical support to the clinical study team and have an overall responsibility of medical oversight/monitoring for clinical studies
  • Ensure the safety of the subjects in the clinical trials through appropriate medical monitoring of studies on a proactive and ongoing basis
  • Perform medical and safety assessments following the review and analysis of Serious Adverse Events, adverse event reports and specified safety inquires and investigations in collaboration with Pharmacovigilance
  • Evaluate pharmacology, safety and efficacy data from ongoing and completed studies
  • Interface with clinicians/investigative sites for protocol-related issues, including protocol clarifications, inclusion/exclusion determinations, and issues of subject safety and/or eligibility
  • Conduct literature reviews and prepare summaries to support clinical development programs
  • Provide medical leadership and scientific guidance to CROs
  • Be a medical resource for design and interpretation of clinical and preclinical programs to support existing and new development pipelines
  • Providing medical expertise to support business development activities and conduct due diligence for assessing scientific, medical and development feasibility
  • Interact with key opinion leaders related to assigned compounds and therapeutic area; contribute to NDA and EMA filings and prepare relevant sections of the regulatory documents; serves as a clinical representative for communications with regulatory agencies

Qualifications

  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree
  • At least 3-5 years of experience in clinical development and medical monitoring
  • Clinical practice including post-graduate direct patient care experience preferred; board certification or equivalent, neurology or psychiatry preferred
  • Clinical trial design and management experience; experience of agency communications preferred
  • Ability and desire to work in a team-oriented environment and work effectively with cross functional teams
  • Excellent verbal, writing, presentation, and editing skills
  • Excellent communication, interpersonal skills to interact with the internal leadership team, external partners and investigators/medical professionals
  • Ability to proactively look into issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Strong knowledge of FDA, EMA, PMDA and other regulatory requirements, GCP/ICH

Luye Pharma USA Ltd.

Address

Princeton, NJ
08543 USA

Industry

Healthcare

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