Manager – Clinical Development

Job Summary of the Manager, Clinical Development

The Manager, Clinical Development role is a key medical affairs position that will have responsibility for managing the new clinical applications growth strategy.  The role focuses on establishing our technology as a standard of care by identifying and developing key drivers for adoption through scientific, clinical, and technical expertise that result in belief creation, technical and procedural standardization, training and scaling clinical experience, developing study parameters, establishing practice guidelines and metrics, with a goal to grow the Company’s business through clinical application development. Specifically, the successful candidate will be required to manage and deliver strategies for customers in new clinical specialties and in new disease states and/or procedures where nerve injury and repair opportunities have been prioritized through direct collaboration and insight gathering with innovators and thought leaders. Lead and maintain relationships with KOLs, maintain awareness of the competitive landscape, assume responsibility as the medical affairs team member on new clinical application expansion opportunities. New clinical applications will be defined as new indications, new institutional segments, and new demographic segments. The position will report to the Sr. Director of Medical Affairs Operations. 

Requirements of the Manager, Clinical Development

• Bachelor’s degree in science, Engineering and/or in a related field. 
• Master’s in business administration or other advanced degree is strongly preferred.
• Minimum of 5 years of demonstrated success and progressive experience in clinical, market development, or product management in the pharmaceutical, medical device, surgical implant, or biotech industry. 
• Experience in developing new clinical opportunities with paradigm-changing technologies preferred.
• Understand and influence the key stakeholders’ drivers for change - patient, surgeons, site of care, and provider
• Able to assess the strategic drivers to influence a market and skilled at building data-driven market models to value the clinical opportunity and costs to frame strategic recommendations
• Ability to segment the market considering the surgeon, the referring physician, and the patient type, identify and resolve drivers and barriers to adoption for each.
• Technical and clinical experience. Understand and shape the technical nuances to build the appropriate clinical data for both clinical adoption and reimbursement.
• Experience understanding and working with care pathways and patient flow
• Demonstrated experience moving from innovators and early adopters across the chasm to the early majority. Clear understanding of the drivers of the different segments of adopters
• Able to make decisions in the face of imperfect data and create performance measures to “course correct” as the market moves
• Able to enroll others in a vision and strategic plan, influence and effectively implement
• Proven track record of building and maintaining Key Opinion Leader relationships
• Orientation towards delivering on goals and being part of a fast-moving, collaborative team 
• Ability to manage multiple priorities in a fast-paced environment • Ability to collaborate, influence, and work with others in a dynamic, matrix environment 
• Must demonstrate strong interpersonal and communication skills with various levels of management and demonstrate the ability to manage differences and needs between multiple stakeholders
• Willing and able to travel domestically, up to 75% of the time to respond to the needs of the customers and organization, some international travel is expected

Responsibilities of the Manager, Clinical Development

The specific duties of theManager, Clinical Development include but are not limited to:

• Becomes an owner and internal advocate for Axogen’s New Clinical Development initiatives
• Collaborate with market development and product marketing to Evaluate and determine market opportunities for Axogen products, Identify primary clinical value propositions,
• Manage team of KOL partners (robotic-assisted radical prostatectomy surgeons, society leadership, patient advocacy groups, etc.,)
• Support and deliver new market value proposition to clinicians and KOLs and share gained insights from field-experience with Axogen
• Support and organize medical and advisory board and sessions
• Recruit and support innovators and early adopters in evaluating new clinical applications
• Provide on-site training and assistance, solicit feedback and evaluate clinical value propositions, provide insights from product performance observations and suggestions to medical affairs, product management, and R&D
• Lead regional early adoption programs and feedback initiatives, stay current on clinical research and developments as well as literature related to Axogen products. Provide critical analysis and summary as needed.
• Conducts market research to assess, define and measure progress in new key clinical development segments
• Supports the development of practice or technique guidelines in a procedure towards a standard of care with support from societies.
• Creates market differentiation which establishes barriers to “me too” followers in the market.
• Develops and communicates a compelling strategy by understanding of the customer, channel and competitive environment.
• Communicates and collaborates to develop market segmentation, targeting, positioning, key messaging and competitive analysis within the development segment
• Develops and collaborates on medical affairs communications including sales collateral creation, company website content, conference and educational events
• Partners with sales leadership to understand market feedback and field training/messaging needs and deliver solutions
• Works directly with thought leaders to assess the clinical and technology needs of the new segment or customer and the underlying broadly held assumptions
• Drives the clinical development strategy and create framework and structure for future initiatives
• Maintains relationships with key societies and oversees clinical conference presence, presentations, and stakeholder meetings
• Demonstrates creative, insightful ideas and implements them quickly and effectively with nominal oversight
• Evaluates and recommends markets/products for growth in peripheral nerve across the organization.
• Creates and monitors clinical and business metrics to demonstrate effectiveness in technical growth and market penetration
• Provides idea generation and creativity in this position, meets deadlines, manages and completes projects through commercialization, and develops techniques in the clinical sale of concepts and products.
• Builds relationships with the key clinical influencers and identify potential opportunities for collaboration.
• Builds and influences the economics of the procedure for all stakeholders.
• Creates programs to lead change in the market, measure penetration into the potential market.
• Identifies the key risk factors in the market and proactively addresses and reduces the risk 

Location

111 West Oak Ave., Tampa, FL  33602 OR Remote

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Benefits/Compensation