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Associate Medical Director
Buisness Area: Clinical Solutions
Location: Natick, MA
Position Code: CSMDR2
Position Description
As Associate Medical Director, the successful applicant will manage and support important activities focused on the oversight of the clinical development program including design, implementation, and safety monitoring of clinical studies, in addition to interaction with internal and external regulatory personnel to advance new products though the regulatory process.
This position is full-time.
Position Responsibilities
- Work closely with the Medical Director, Chief Medical Officer and the Clinical Solutions Practice Leader to successfully manage clinical development programs in accordance with operating timelines, GCP-compliant Standard Operating Procedures, and other applicable SOPs and regulations
- Uphold processes that ensure the absolute integrity of clinical study data sets, analysis, and Clinical Study Reports
- Interface with statistical personnel to plan data analysis
- Manage outsourced safety monitoring services, including review and trending of safety data
- Support the preparation of protocols, investigator's brochures, medical reports, and regulatory submissions
- Support the development of timetables, budgets and resource analyses for clinical programs and personnel administration
- Establish and maintain relationships with alliance partners, external companies, investigators and opinion leaders to optimize performance on clinical trial activities
- Develop and maintain a daily clinical development workplan and calendar that tracks activities, milestones, and initiatives
- Support the client's regulatory, product registration, quality, and medical communications goals by performing a range of study reporting, planning, and presentation activities
- Project a mature, professional image and provide responsive, meaningful, high-quality support and follow-up to executive and investigator inquiries
- Travel (US and international) of ~20% - 60%
- Develop and maintain the requisite computer skills to effectively utilize state-of-the-art office equipment and systems (Ongoing testing and certifications may be expected.)
- Report to the Medical Director
Position Qualifications
- Minimum 3-5+ years successful clinical operations and regulatory experience with leading biomedical industry firms in the medical device, pharmaceutical, and/or contract research industries
- Fluency in harmonized GCP standards, the medical device product development and approval process, HIPAA, 21CFR Part 11, the FDA Quality System Regulations, and ISO 13485 (2003)
- Strong, documented proficiencies in Good Clinical Practices and related Standard Operating Procedures
- Comprehensive understanding of the medical product development process
- Successful, significant contributions to Class II and III medical device regulatory submissions and approvals
- Medical degree from a leading university. Post-graduate training in Clinical Research, Statistics, and/or Epidemiology a plus
- Certifications/Licensure in Medicine or Surgery, Regulatory Affairs, Clinical Research, Microsoft Windows and Office applications a plus
- Must be willing to relocate to the Boston area permanently, for up to 3 years
- Excellent presentation and communication (both oral and written) skills
- Excellent time management, planning, and teamwork skills
- Must be willing to work hours as needed to meet deadlines and needs
- Must possess a valid driver's license and the ability to qualify for and maintain a corporate credit card with sufficient credit line to enable extensive business travel
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