What are the responsibilities and job description for the Sr Clinical Research Scientist position at Lifelancer?

Job Title : Sr. Clinical Research Scientist

Job Location : Tampa FL USA

Job Location Type : Remote

Job Contract Type : Fulltime

Job Seniority Level : MidSenior level

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our handson 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
Companywide dedication to profoundly impacting patients’ lives
Comprehensive highquality 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

If you want to see how you can impact lives at Axogen take a look at these inspiring 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 benefittorisk profile as compared to existing standards of care. To ensure we deliver improved benefittorisk 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 Sr. Clinical Research Scientist

The Sr. Clinical Research Scientist will play a critical role in leading and managing clinical research activities with a focus on advancing peripheral nerve science and its clinical applications. This position requires expertise in clinical trial design data analysis and regulatory submissions ideally within the biotech or medical device industries. The successful candidate will collaborate crossfunctionally to drive the development and execution of clinical strategies that support product efficacy safety and regulatory compliance.

Requirements Of The Sr. Clinical Research Scientist

Advanced degree (PhD PharmD MD) in life sciences clinical research biomedical engineering or a related field.

Minimum 5 years of experience in clinical research in the biotech or medical device industry including experience in leading clinical trials.

Indepth knowledge of clinical trial design regulatory requirements and GCP.

Experience with FDA submissions including INDs BLAs PMAs and / or 510(k)s.

Strong leadership skills with the ability to work in crossfunctional teams.

Excellent written and verbal communication skills including the ability to present complex clinical data to both scientific and nonscientific audiences.

Responsibilities Of The Sr. Clinical Research Scientist

The specific duties of the Sr. Clinical Research Scientist include but are not limited to :

Clinical Study Design and Protocol Development :

Lead the design and development of clinical study protocols including objectives endpoints sample size determination and statistical analysis plans.

Collaborate with crossfunctional teams (regulatory R&D biostatistics etc.) to align study design with regulatory strategies and product development goals.

Contribute to the development of clinical strategies to support product claims and marketing.

Clinical Study Execution :

Oversee the execution of clinical studies ensuring compliance with Good Clinical Practice (GCP) relevant regulations and company standards.

Provide scientific oversight and ensure clinical data integrity and quality throughout the study.

Manage relationships with key opinion leaders (KOLs) investigators and clinical research organizations (CROs).

Data Analysis and Interpretation :

Collaborate with biostatistics and data management teams to ensure accurate data analysis and reporting.

Interpret clinical study results and generate clinical study reports publications and presentations.

Provide scientific input on interim analyses final analyses and any safetyrelated issues that arise during the trial.

CrossFunctional Collaboration :

Work closely with R&D regulatory affairs quality and commercial teams to ensure clinical program alignment with business objectives.

Participate in project team meetings and provide clinical updates and scientific insights.

Support product development by integrating clinical evidence into product design development and labeling.

Scientific Communication and Publications :

Develop and deliver scientific presentations at industry conferences advisory boards and internal meetings.

Lead the preparation and submission of manuscripts for peerreviewed journals contributing to the company’s scientific reputation.

Compliance and Risk Management :

Ensure compliance with all relevant clinical research guidelines ethical standards and regulatory requirements.

Identify and mitigate risks related to clinical trial conduct including patient safety data integrity and operational challenges.

Innovation and Continuous Improvement :

Stay updated on the latest trends technologies and methodologies in clinical research and the therapeutic area of focus.

Drive process improvements in clinical operations study design and data management practices.

Location

13631 Progress Blvd. Alachua FL 32615

111 West Oak Ave. Tampa FL 33602

Remote

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

122386 — $152982 USD

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.

Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.

For more details and to find similar roles please check out the below Lifelancer link.

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Apply on Lifelancer Platform

Key Skills

Laboratory Experience,Machine Learning,Python,AI,Bioinformatics,C / C ,R,Biochemistry,Research Experience,Natural Language Processing,Deep Learning,Molecular Biology

Employment Type : Full Time

Vacancy : 1

Salary : $152,982

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