Clinical Development Scientist
AxogenAbout the role
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you’ll love working at Axogen:
- Friendly, open, and fun team culture that values unique perspectives
- Company-wide dedication to profoundly impacting patients’ lives
- Comprehensive, high-quality benefits package effective on date of hire
- Educational assistance available for all employees
- Matching 401(k) retirement plan
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Clinical Development Scientist
The Clinical Development Scientist assists in the design, preparation, planning, analysis and interpretation of data for clinical projects and studies. This position ensures adherence to federal, state and AATB requirements and company and ethical standards.
Requirements of the Clinical Development Scientist
- Minimum of BS in Life Sciences (MS or PhD preferred)
- Minimum of 5 years’ experience in clinical research
- Strong sense of pride in your work product
- Ability to take ownership in a project and drive it to completion
- Passion for advancing scientific knowledge
- Awareness of the impact of your contributions on your team, the company, collaborators, customers, patients, medical science and society
Responsibilities of the Clinical Development Scientist
The specific duties of the Clinical Development Scientist include but are not limited to:
- Provide guidance on the design of clinical projects and studies to ensure appropriate data is collected to support commercial and healthcare economic initiatives
- Assists with translation and interpretation of clinical data to assist with evidence generation activities such as manuscripts, abstracts, marketing collateral, and/or other internal scientific communications
- Critically interpret relevant literature
- Serve as a resource for clinical knowledge
- Support investigator initiated clinical studies as assigned while ensuring adherence to institutional, local, federal, state, and company ethical standards
- Serve as a content expert and liaison to the commercial teams related to clinical trial evidence for training and collateral material related to clinical programs
- Develop or assist with the development of study-specific documents essential to appropriate implementation of clinical investigations
- Participate in cross-functional efforts to improve clinical development initiatives
- Assist with preparation and execution of Investigator meetings
- Present information and data at investigator and team meetings
- Assist with preparation of Ethics Committee submissions and notifications/submissions to federal and state regulatory authorities
- Participate in project team meetings and provides clinical representation
- Provide clinical support in working with the FDA
- Follow company policies, procedures and standard operating procedures
- Perform other duties as directed by the Supervisor
Location
111 West Oak Ave., Tampa, FL 33602
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Benefits/Compensation
This position is eligible for an annual bonus.
Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance,
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