The position of Medical Director within Clinical Research and Development is primarily responsible for clinical development programs including medical guidance for all aspects of drug development including protocol design, clinical trial site recruitment and monitoring, data interpretation and reporting. The Medical Director will support and play a key role in developing/implementing larger Phase II and III studies including future interactions with the FDA, IND, and NDA submissions.
Essential Duties and Responsibilities
· Target patient population evaluation, clinical development program design, protocol design, endpoint selection, clinical utility, current standard therapy, competitor identification, and regulatory agency interaction.
· Working with cross-matrix teams for integrated clinical programs aligned with regulatory approval pathways.
· Development, plan, and implementation of clinical research programs and trials.
· Lead role in clinical projects for medical and scientific soundness; provision of medical input to project teams.
· Development, management, and approval of the scientific methods for design of clinical protocols, case report forms, guidelines, study reports, and manuscripts.
· Provision of protocol and/or therapeutic area training for the internal and external project teams.
· Assistance in investigator identification and selection.
· Development and review of informed consent documents; evaluate subject eligibility for clinical trials.
· Assurance of subject safety, adequate reporting, and coding of adverse events in clinical trials.
· Oversee the generation of Medical Monitoring/Safety Plans.
· Ensure timely updates to protocols, Investigators Brochures, and product labels as required.
· Participation in and/or presents at Investigator Meetings.
· Interactions with Contract Research Organizations (CROs), healthcare consultants, and investigators.
· Oversee and participate in clinical study report writing, critical medical review, and assessment of written documents.
· Attend/participate in training lectures, symposia and conferences in order to maintain current license and maintain and promote Company’s therapeutic area(s) of expertise.
· Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
· Medical degree , PharmD or PHD is required. A subspecialty training would be preferred.
· United States (US) medical license is preferred but not required.
· Minimum 4 years’ experience in pharmaceutical clinical development, academic research, or a clinical research organization (CRO), with evidence of successful ongoing career development.
· Excellent oral and written English communication skills.
· Experience with the US Food and Drug Administration is desired but not required.
· Ability to make decisions independently and with appropriate input.
· Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, and Medical Affairs.
· Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.