Job Opportunities

HCRI has an opening for an Associate Medical Director to provide physician leadership and oversight in managing the activities of the Clinical Safety group within the Clinical Development Department.  The Associate Medical Director will work with the Senior Director, Medical Affairs.  Their role will be primarily to develop and coordinate all policies and procedures related to all Pharmacovigilance activities at HCRI.

Primary Duties and Responsibilities:

• Provide leadership in the formulation and updating of appropriate guidelines and operating procedures for all Pharmacovigilance activities
• Provide medical oversight of Clinical Safety services including medical review of AE coding and SAE evaluation
• Provide medical oversight to determine the required follow-up and/or requirements for expedited reporting. 
• Oversee the development of case report forms for all new trials to ensure critical elements for Safety reporting are incorporated. 
• Develop Coding conventions for all new trials in various therapeutic areas (ie: Cardiovascular, Oncology, Neurology, etc.).
• Participate in the IND Safety Report/Investigator Letter expedited reporting process 
• Partner with project teams to review and provide assurance of medical content and clinical relevance of regulatory safety information provided in documents including but not limited to; Investigator's brochures, protocols, safety narratives, integrated safety summaries, NDA/MAA submissions, final study reports and other periodic or ad-hoc regulatory reports as designated 
• Serve as a material expert in crafting Safety responses to questions from regulatory authorities, data safety monitoring boards or sponsor requests, and/or sponsors in the pharmaceutical, device, or biologic industries. 
• Responsible for continuous Pharmacovigilance Quality Assurance and quality control procedures.
• Design and review weekly trend reports based on SAE reporting. Communicate concerns as defined by study monitoring plans to the Lead Trial Physician and Trial Project Manager, Data Safety Monitoring Board, and the Senior Director, Medical Affairs
• Oversee Safety Group staff recruitment, training, and career development planning
• Oversight and active participation in the Medical Monitoring group which provides support and resolution of medically related issues, including study eligibility, event reporting, and study follow-up
• Oversee and guide the staff  identification of appropriate external meetings, continuing education, coursework and capabilities 
• Communicate and interact effectively within a matrix environment including project based teams, internal departments and external stakeholders
• Maintain competence and current fund of knowledge through regular completion of training and course update as related to primary employee functions
• Oversee and mentor staff involved with medical monitoring activities
• Participate in multi-disciplinary committees and working groups as the Safety Representative.
  

Requirements:
Education: MD degree and appropriate clinical practice experience.  Board certification in Medicine or Surgery preferred.

Experience: At least 2 - 3 years of Clinical Safety experience in Pharmaceutical, Medical Device Company or CRO, with management experience.

Licenses:    Active Medical License in any state within in USA.

Skill Sets:    Demonstrated leadership and management ability; strong knowledge of pharmacovigilance & medical device regulations; strong verbal, written communication and presentation skills;  demonstrated ability to perform in a team and matrix environment; analytical thinking ability, understanding of data entry conventions and expertise in search functions in safety databases and strong people-management and coaching skills     are some of the skills that are valuable for success in this position.

Working Relationships:
Clinical Safety Associates - assist in development of guideline documents and provide medical overview of coding and SAE assessments

Project Management - provide medical consultation related to protocol and other study questions

Data Management - provide medical consultation related to protocol and other study questions; assist in the coordination and development of AE coding procedures
Clinical Reviewers - assist in event review and development of Clinical Events Committee (CEC) manual of operations for specified trials and independent data safety monitoring boards (DSMB)

HCRI Management - participate in meetings with other managers resolving operational, policy/procedural issues.