AngioDynamics Director, Medical Affairs in Marlborough, Massachusetts
The Director of Medical Affairs will work cross functionally to advance the development, planning and execution of pruduct scientific strategy and tactics. Responsible for operational oversight within Medical Affairs to achieve organizational objectives. Manages the design and implementation plans of the medical affairs program, including identification of strategic objectives and tracking of all projects.
Essential Duties and Responsibilities
- Manage internal and external resources to advance the objectives of Medical Affairs and the organization.
- Lead the development of formalized product scientific strategy with input from Medical Director, MD consultants, and cross-functional teams; ensure clear and efficient communication of scientific strategy internally and externally.
- Ensure tactics align with product scientific strategy; communicate with internal and external stakeholders to track execution and progress and implement modifications where necessary.
- Identify opportunities for appropriate, relevant generation or communication of scientific data. Proactively manage portfolio publication pipelines in alignment with strategic plans.
- Provide scientific insight related to research areas of focus, oversight and review of global medical education, global grants program and external research priorities.
- Engage key opinion leaders, translating customer insight into strategic and tactical planning.
- Ensure compliant, timely, and accurate responses to requests for medical information (including unsolicited requests for off label information). Respond to and anticipate changes within the heavily regulated, compliance-driven medical communications arena.
- Collaborate with Clinical Affairs on study design and protocol development; including literature review, methods development, KOL and site identification, protocol revisions, medical soundness.
- Implement Scientific Review process for IITs, creating externally communicated scientific research priorities; manage review of submitted proposals: protocol assessment, investigator relationship management and alignment of expectations, assistance with publications.
- Research and provide reports on the clinical data in support of diverse corporate initiatives including regular journal tracking reports and summaries of key publications, as well as regulatory submissions (including Clinical Evidence Reports, IDEs and 510ks).
- Acts as liaison and represent Medical Affairs in meetings and on committees as assigned.
- Participates in activities related to product support:
- Strategic planning
- Competitive intelligence
- Due Diligence
- Medical conference data review
- Serve as Medical Affairs representative during preclinical study procedures.
- Assist in the development of core curriculum and certification of clinical field representatives, contribute to continuing education of sales team members.
- Support Advocacy for AngioDynamics through relevant societies and consultants to drive reimbursement and coding.
- Manage Medical Affairs initiatives, including:
- MABs, KOL meetings, and Focus Groups
- Conference support and attendance
- Product evaluations and needs assessment
- Sales and marketing team education
- Assist Medical Director with patient and physician complaint response management in concert with post market surveillance groups.
- Facilitate discussions with physician investigators and practitioners, to establish accurate and objective positions regarding medical usage and standard of care practices.
- Provide Medical Affairs assistance with specific IDE and 510(k) submissions; prepare and contribute in meetings with the FDA to assist in product approval process.
- Work with internal and external legal counsel to ensure compliant processes within MA.
- Domestic and international travel is required.
- May perform other duties as assigned
- Supervisory Responsibilities
- Manages in order to ensure compliance with all relevant regulatory/legal requirements
QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES
- Management - Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure all employees are trained to do their work and their training is documented
Education & Experience
- Bachelor's Level of Degree in the science or technical field of study
- 12 years of demonstrated experience in medical affairs/clinical development for the medical device industry with a minimum of 5 years experience managing and leading staff.
- Advanced degree, Masters/PhD
- Experience of the management of the medical affairs/clinical research processes for medical device
- Understanding of clinical trial design, regulatory processes, and project management
- Ability to develop and maintain excellent working relationships with internal teams and external customers
- Demonstrated ability interfacing with regulatory agencies and internal partners at a strategic level
- Excellent communication and presentation skills
- Ability to work in a fast paced environment with competing priorities
- High level of attention to detail
- Ability and desire to work in a team-oriented environment
- Proficient in the following computer software applications: MS Office products, particularly Word, Excel, and PowerPoint; Publication management software
- Exceptional interpersonal skills.
- Strong organizational skills.
- Strong communication skills (written and verbal).
- Ability to effectively communicate both internally and externally.
- Ability to read and interpret documents such as safety rules, operating and maintenance. Instructions and procedure manuals. Ability to write routine reports and correspondence.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Work safely and follow all OSHA regulations and company safety policies and procedures.
- For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
- Exposure to standard office environment
- Ability to frequently lift and/or move up to 15 lbs
- Ability to occasionally lift and/or move up to 50 lbs
- Ability to regularly sit or stand for extended periods of time
- This position requires some travel up to 20% of the time
As an Equal Opportunity / Affirmative Action Employer, AngioDynamics will not discriminate in its employment practices due to an applicant’s race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity or expression, age, national origin, marital status, citizenship, physical and mental disability, criminal record, genetic information, predisposition or carrier status, status with respect to receiving public assistance, domestic violence victim status, a disabled, special, recently separated, active duty wartime, campaign badge, Armed Forces service medal veteran, or any other characteristics protected under applicable law.
The company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed,or disclosed their own pay or the pay of another employee or applicant.
Requisition Number: 1524BR
Title: Director, Medical Affairs
Type of Position: Fulltime-Regular
Department: Medical Affairs
Location: Marlborough, MA