Associate Director/Director, Medical Monitor

← Back to Jobs

Luye Pharma USA, Ltd.

Princeton, NJ

Posted: January 13, 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