Scientific Affairs Manager

Scientific Affairs Manager

Requirements

• Minimum of a bachelor’s degree; A relevant postgraduate qualification (PhD/research-based MSc/PharmD)
• Minimum of 5 years industry experience, post-doctoral research and/or practical research/laboratory work experience is beneficial.
• Knowledge of FDA regulations for medical device, human tissue, and biologics is beneficial
• Experienced and knowledgeable about related pre-clinical models
• Skilled and experienced in experimental study design and data
• Knowledge of scientific approach and current technological developments/trends in area of scientific research principles, practices
• Ability to design, organize, and coordinate projects, especially literature
• Ability to work with cross-functional teams
• Excellent oral and written communication skills including the ability to accurately rely on a compelling value proposition for Axogen’s portfolio of nerve repair products
• Ability to transfer knowledge to others and coach them to achieve goals
• Pleasant, professional, and proactive self-starter who enjoys being part of a fast moving and growing environment
• Willing and able to travel domestically, up to 50% of the time to respond to the needs of the customers and organization
• Ability to establish and maintain good working relationships
• Self-directed, organized and goal-oriented
• Proficiency with MS Office Applications including Word, Excel, Outlook, and PowerPoint

Responsibilities

• Provides scientific leadership for the company through the generation and maintenance of scientific messaging platforms for all Axogen technologies and clinical applications.
• Provides scientific leadership and delivers expert scientific recommendations for the brand team by partnering with the brand managers in the planning and development of marketing materials and activities.
• Educates the medical and marketing teams by identifying new published data for a specific product – via congresses, peer-to-peer discussions, literature alerts – and disseminating them to the teams.
• Reviews and approves promotional and non-promotional material to ensure scientific accuracy and adherence to scientific messaging platforms.
• Leads medical affairs projects and activities such as: delivery of educational symposia, creation of sales training material, training of sales force, and internal department training through regular journal club meetings and other trainings as necessary.
• Supports handling of product inquiries from stakeholders.
• Leads the pre-clinical research grant committee and serves as the main scientific contact.
• Responsible for clinical literature surveillance for articles related to our products and quarterly updates to the clinical bibliography.
• Responsible for Pharmacovigilance activities related to clinical literature.
• Leads the Medical Affairs portion of the annual Clinical Evaluation Report (CER).
• Leads the clinical literature review/State of the Art (SOTA) creation process for new products.
• Serves as the scientific lead in the planning stage of new marketing projects providing scientific expertise and value during scoping of specific activities.
• Attends scientific meetings and congresses to enhance expertise and shares insights with sales and other stakeholders to support business needs.
• Provides insights about our products following peer-to-peer discussions with healthcare professionals (HCPs).

Preferred Qualifications

• Strong preference will be given to candidates with experience in the peripheral nerve space and to those with experience with paradigm changing technologies.