The Senior Medical Director for Clinical Development is responsible for the Clinical Development Group within the Clinical Operations Department. The individual also serves as a medical resource to Marketing and Medical Affairs, other Departments at the company as needed, and as the medical team leader on all out-sourced clinical studies. This may include, but is not limited to, the following: Pharmacovigilance activities associated with their assigned drug development programs and participating as Medical Monitor for clinical trials conducted by the Clinical Operations Department.
Essential Duties and Responsibilities
Strategic Planning - Pharmaceutical Product Development
Target patient population evaluation
Clinical development program design
Current standard therapy
Regulatory agency interaction
In conjunction with senior management, develops, plans and implements clinical research direction and vision
Oversees clinical projects for medical and scientific soundness; provides medical input to project team
Reviews pre-clinical programs to ensure adequacy and scientific rigor
Develops, manages and approves the scientific methods for design of clinical protocols, case report forms, guidelines, study reports and manuscripts
Provides protocol and/or therapeutic area training for the internal and external project teams
Assists in investigator identification and selection
Develops/reviews informed consent documents
Insures subject safety and adequate reporting and coding of adverse events in clinical trials
Oversees generation of Medical Monitoring/Safety Plans
Reviews/signs off on Pharmacovigilance activities associated with drug development programs and participating as Medical Monitor for clinical trials conducted by Clinical Research and Development department.
Ensures timely updates to protocols, Investigators Brochures, and product labels as required.
Evaluates subject eligibility for clinical trials
Participates in and/or presents at Investigator Meetings
Participates in afterhours medical coverage for clinical projects if required
Evaluates/reviews project endpoints
Interacts with Contract Research Organizations (CROs), consultants, and investigators
Provides medical (technical) support for internal and external Project Management, Data Management, Biometrics and Clinical Writing
Oversees/participates in clinical study report writing and/or critical medical review and assessment of written documents
Oversees Medical Affairs activities for all Divisions of the Corporation
Implements proper procedures to ensure compliance with Regulations, Guidelines and SOPs
Oversees/participates in review and approval of Grant Requests
Reviews and Approves all Phase IV clinical programs
Ensures Phase IV programs adhere to corporate SOPs and regulatory Guidelines
Participation in Business Development and Education Programs
Liaises with clients and provides medical/scientific expertise in support of new business ventures
Provides education of potential project teams regarding medical background for proposed projects
Delivers/oversees business development presentations.
Delivers/oversees educational programs for health care providers
Participates in administrative activities as required by the Vice President of Clinical Operations in order to maintain smooth functioning of the Division and compliance with SOPs and local guidelines
Attends/participates in training lectures, symposia and conferences in order to maintain current license and maintain and promote Company’s therapeutic area(s) of expertise
Provides cross-coverage for the Director of Pharmacovigilance as required
Qualifications and Requirements
Excellent oral and written English communication skills. Medical degree (M.D., DMD, DDS, or DVM), Subspecialty Training Preferred; U.S. Medical license.
At least 1-4 years’ experience Assistant Medical Director or Associate Medical Director/Monitor (Pharmaceutical or CRO) required, with evidence of successful ongoing career development; additional safety or other pharmaceutical development experience (example: Study Investigator, CRA, project management) will be considered in addition to, but not in place of, medical monitoring
Experience as a project team leader with major responsibility for at least one NDA submission desired.
Able to function in multiple therapeutic areas and manage multiple drug development programs simultaneously. Flexibility in adapting to multiple therapeutic areas interchangeably and situational strategic direction.
Prior management experience as evidence by previous direct reports.
Drug development experience including list of drugs and role-played in their development. Experience as direct medical liaison with FDA desired, but not required. Experience in Safety Surveillance, knowledge of drug development safety requirements and history of experience working with safety monitors essential.
Ability to prioritize and perform multiple tasks simultaneously.
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 Marketing and Professional Services.