Relievant Medsystems, Inc.
Join our vision to transform the treatment of chronic low back pain. As a 2023 Gallup Exceptional Workplace Award winner, we have an active and engaging culture where your contributions will lead to a meaningful career. Our inclusive and collaborative environment enables employees to thrive by practicing our core values of integrity, passions, respect, collaboration, creativity, and achievement. We offer an excellent compensation and benefits package to our employees.
Position Summary:
This position is responsible to independently oversee a portfolio of clinical projects, clinical publications, evidence activities and clinical leaders. The position collaborates with the clinical leadership and physician advisors to establish clinical study strategies and study designs that are aligned with the Evidence Plan, therapeutic & scientific needs, and business objectives. This position may oversee aspects of the investigator sponsored research (ISR) program.
This position may also perform aspects of trial and team leadership for pre-clinical, investigational, and post market clinical studies as well as healthcare economic studies or data mining activities.
Location:
Our corporate office is in Edina, MN. We offer a hybrid work model that includes 3 days working from our corporate office (M-W) and remote work Thurs. and Fri., with some flexibility.
Essential Duties and Responsibilities:
Evidence Planning & Publications Responsibilities:
- Collaborates with Clinical, CMO, Regulatory, R&D, Reimbursement, and Marketing leadership as well as key physician advisors as assigned to define aspects of the Evidence Plan and Publications Roadmap.
- Identifies clinical /regulatory evidence strategies for assigned aspects of the Evidence Plan.
- Responsible for driving execution for assigned larger evidence strategies and associated activities of the Evidence Plan.
Publications Responsibilities:
- Collaborates with investigator authors in development of manuscripts for clinical results that are in alignment with the Evidence Plan, individual study Publication Plans, and clinical/business strategies (within the constraints of the data).
- Collaborates with marketing, training, and field functions in dissemination of clinical results including physician presentation development, training materials for clinical content, and key messaging / claims statements within marketing materials/webinars/websites.
Investigator Sponsored Research (ISR) Responsibilities:
- Point of contact for assigned unsolicited ISR grant proposals
- Acknowledges receipt of assigned proposals, screens proposals, and communicates with sponsor investigators to refine proposals, as needed.
- Presents assigned proposals to the Evidence Planning Committee (EPC), documents EPC review, comments, and decision. Communicates EPC decision to the sponsor investigator.
- Prepares ISR Grant Agreements, deliverables, timelines, and budget for approved ISRs. Discusses these with the sponsor investigator.
- Supports sponsor investigator in design of study and protocol by providing review and feedback as requested.
- Liaison to the sponsor investigator for assigned ISRs throughout the project.
- Provides periodic updates on assigned ISRs progress to the EPC.
Data Mining Responsibilities:
- Oversees the development of hypotheses and protocols for individual data mining / machine-learning efforts in collaboration with VP of Clinical and cross-functional leadership / physician steering committee members.
- Defines study populations, data pulls, reports, and statistical analysis plans with input from clinical data management and statisticians.
- Reviews preliminary reports and provides direction to the statistician.
- Overviews reports internally with clinical and medical affairs and with physician steering committee members.
- Supports the physician steering committee and authors in development of publication of findings in alignment with the Evidence Plan and under the direction of the VP of Clinical and EPC.
Sponsored Project Management & Oversight Responsibilities:
- Oversees the development and review of IDE submissions and participates in regulatory meetings and reviewer discussions for investigational studies.
- Oversees development and/or reviews and approves the Clinical Investigation Plan to ensure alignment with the clinical strategy and business objectives. Collaborates with study principal investigators, physician/clinician advisors, statistician, clinical leadership, and study team throughout this process.
- Oversees development and reviews the Investigator’s Brochure for investigational studies.
- Develops assigned portfolio portion of the clinical annual operating plan. Establishes individual clinical study budgets, timelines, and deliverables.
- Creates study management reports and provides update to leadership regarding study progress. Executes to budget, study plans, and deliverables.
- Oversees the investigator selection process and ensures qualification criteria are met. Reviews and approves individual site strategies for subject enrollments, study conduct, and compliance.
- Reviews and approves study materials including informed consent form(s), clinical trial agreements, case report forms, site activation materials, training materials, and other study specific documents/templates.
- Oversees the development of a data management plan and data collection methods; collaborates with database developers to establish expectations and budget for clinical database(s) and systems; ensures appropriate database development, validation, and testing; ensures execution to the data management plan and overall integrity of the data within committed timelines.
- Reviews and approves the study monitoring plan; ensures execution to the plan.
- Establishes and carries out appropriate action plans, in cases of clinical study site non-compliance, to re-establish appropriate regulatory and/or protocol compliance.
- Oversees development and/or reviews and approves all study reports to ensure they are accurate and comprehensive.
- Collaborates with individual study publication committee and investigator authors in publication of clinical results that are aligned with the Publication Plan and clinical/business strategies (within the constraints of the data).
Study Team Management Responsibilities:
- Assigns roles and responsibilities within the clinical trials
- Ensures adequate training and competency for study functions assigned.
- Performs regular 1:1 meeting to assess progress for study responsibilities
- Performs performance review of study team personnel
- Performs the training and development of study team personnel
- May have direct report responsibilities of clinical personnel
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all job responsibilities and duties.
Qualifications:
Education:
- Bachelor’s degree or equivalent in health-related field or biological sciences
Experience:
- 10+ years of work experience in a clinical research environment
- 8+ years of experience in global trial leadership (pre-market and post market studies) and study team oversight.
- 7+ years of experience with direct clinical personnel management, 2+ years of experience leading managers.
- Medical device and FDA experience preferred
- Startup company experience strongly preferred
Key Skills & Aptitudes:
- Proficient in regulatory and compliance guidelines relevant to conducting clinical studies
- Proficient in clinical strategy development and project leadership
- Experience in evidence planning participation
- Proficient oral and written communication skills; solid presentation skills
- Effective problem-solving skills and solid business acumen
- Ability to work effectively in the medical community
- Availability to travel 10% to 20%
Relievant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We are proud to offer our employees an excellent compensation and benefits package and we are an equal opportunity employer.
For more information or to apply, please add the name of the position in the subject line along with your resume to: careers@relievant.com.