Manager, Clinical Research Science
Axogen, Inc.

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
• Flexible working hours
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/

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 Manager, Clinical Research Science

The Clinical Research Science Manager (CRSM) will assist in the definition, design, analysis, and interpretation of selected clinical programs and projects. This role will manage the day-to-day activities, including clinical science team members and consultants as assigned, to model, analyze, interpret, and translate clinical data to regulatory and clinical audiences. The CRSM will provide scientific expertise for internal and external projects and will interface with cross-functional teams, thought leaders, academic researchers, subject matter experts, clinicians, surgeons, and regulatory agencies.

Requirements of the Manager, Clinical Research Science

• 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 of 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 Manager, Clinical Research Science

The specific duties of the Manager, Clinical Research Science include but are not limited to:

• Serve as primary point of contact for assigned clinical projects in the data analysis phase
• Management of clinical study designs and analysis methodologies to ensure appropriate data is collected to support regulatory, postmarketing, and/or health economic initiatives
• Evaluation of Real World Data sources for generation to Real World Evidence to support regulatory, post-marketing, and/or health economic initiatives
• Creation and finalization of protocols, statistical analysis plans, and other study-specific documents essential for the appropriate implementation of clinical investigations • Establish plans for data processing and data review in collaboration with Clinical Operations
• Management of internal and external scientists, statisticians, programmers, and writers to execute, analyze and interpret clinical data as assigned
• Interpretation and translation of clinical data for dissemination to Clinical Study Reports and Stakeholders
• Critically interpret relevant literature. Serve as a resource for clinical knowledge.
• Manage Clinical Research Organizations and consultants.
• Provide clinical support to Regulatory in working with US and OUS Regulatory agencies including market submissions, reports, or communications
• Participate in project team meetings and provides clinical representation
• Assists with preparation and execution of Investigator meetings as needed
• Present information and data at investigator and team meetings
• 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
• Follow company policies, procedures and standard operating procedures.
• Perform other duties as directed by the Supervisor

Location

111 West Oak Ave., Tampa, FL 33602

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, as described in more detail in summary plan descriptions.

Salary Range

$122,386-$152,982 USD

Axogen is on a hybrid work schedule for some of our positions based out of our headquarters in Florida, with 3 days in office and 2 days remote. The hybrid work schedule does not include sales or facilities in Ohio or Texas.

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

If you know someone who would be a great candidate for this position, or any others, just copy and send this link! https://grnh.se/cc84962d2us

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