Randstad Medical Director in Parsippany, New Jersey
salary:$225,000 per year
date posted:Thursday, December 6, 2018
industry:Professional, Scientific, and Technical Services
The purpose of this position is to provide oversight with regards to medical issues that impact the full clinical development spectrum for the assigned product. The job will include extensive involvement in the design of clinical development plans, clinical trial synopses and protocol development as well as functioning as the medical monitor for the clinical trials (including medical evaluation of adverse events and drug safety).
The position will be responsible for overall successful conduct of the clinical trials including oversight of the clinical data quality and achieving the key study milestones in a timely manner. The position will work seamlessly with clinical operations, drug safety, pharmacovigilance, data management/statistics and regulatory as well as other groups within the organization (commercial, business development, etc.) to ensure the appropriate dispersal of information within the company and, as necessary, with external advisors.
location: Parsippany, New Jersey
job type: Permanent
work hours: 9 to 5
Oversees all medical aspects of study design.
Medical monitoring of clinical studies.
Medical evaluation of pharmacovigilance and drug safety reports (pre- and post-marketing).
Assists with execution of clinical studies to establish the safety, efficacy and commercial viability of new products.
Actively participates in site selection and assists with providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures.
Actively participates in study management with the cross functional clinical team (clinical operations, drug safety, pharmacovigilance, data management/statistics and regulatory, etc.) to ensure the team will achieve key study milestones including timeline and ensure high data quality from the clinical studies assigned.
Assists with study vendors selection and education.
Works with Clinical and Regulatory Affairs in the preparation of project- related documents and regulatory submissions, including Investigator's Brochures, Annual Reports, INDs and NDA's.
Is responsible for medical monitoring portion of site initiation, site oversight and monitoring, on-site presentations, site close-out and especially understanding of adverse events.
Communicates and interacts effectively with in-house personnel, clinical sites and outside contractors/CROs.
Has a teaching role in investigator meetings.
Participates in the formulation of overall clinical strategy.
Functions as Medical reviewer for PV department.
MD, PharmD, DO from an accredited college or university.
At least 5 years clinical research experience in the U.S. biotech/pharmaceutical industry.
Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development regulations and processes.
Excellent written and oral English communication and presentation skills
Proven ability to work effectively on a team in an entrepreneurial environment.
Must be able to quickly and adeptly spot patterns in questions and feed them back to the clinical, commercial,and medical affairs staff.
skills: Clinical research, Pharmacovigilance, Clinical Study Design, CTMS (Clinical Trial Management Systems)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.