Our team is growing, and we currently have an immediate opening for a Medical Science Liaison (MSL)
Location:
Remote or Hybrid (Cleveland, Ohio)
Reports to:
VP Medical Affairs or Chief Medical Officer
Job Description:
The Medical Affairs Professional serves as a key scientific and clinical expert for Cleveland Diagnostics flagship IsoPSA product, a Class III In Vitro Diagnostic (IVD) assay for prostate cancer risk stratification. This role is responsible for driving the appropriate clinical utilization and scientific understanding of IsoPSA by engaging with Key Opinion Leaders (KOLs), generating real-world evidence, and ensuring accurate, compliant scientific communication across the organization and to the external medical community.
Essential Duties and Responsibilities
1. Scientific Exchange and Key Opinion Leader (KOL) Management
Establish and maintain relationships
with national and regional KOLs, investigators, and clinical societies (e.g., Urology, Oncology) to ensure a deep understanding of the scientific and clinical value of IsoPSA.
Serve as the
primary scientific resource
for external stakeholders, conducting
fair-balanced, evidence-based scientific exchange
on IsoPSA data, mechanism of action (IsoClear - Solvent Interaction Analysis (SIA) platform and methodology), and its role in the prostate cancer diagnostic pathway.
Gather and relay
clinical insights and unmet needs
from the field back to internal teams (e.g., R&D, Commercial, Regulatory Affairs, Clinical Operations) to inform product lifecycle planning, clinical strategy, and educational content.
2. Evidence Generation and Research Support
Support clinical research initiatives under the supervision of the Clinical Operations team by serving as a primary contact to investigators for investigator-initiated studies (IIS), facilitating internal review of IIS proposals for feasibility and conduct, identifying potential sites/investigators for sponsored trials, and assisting in site communications during active sponsored trials.
Support the
design and execution of Health Economics and Outcomes Research (HEOR)
studies to demonstrate the real-world value, clinical utility, and payer-access benefits of IsoPSA.
Contribute to the development of
clinical abstracts, posters, and manuscripts
for presentation at national and international medical conferences and publication in peer-reviewed journals.
3. Medical Education and Communication
Develop and deliver
training
on the scientific data and clinical use of IsoPSA for the Commercial, Market Access, Research & Development, and Clinical Operations teams.
Lead the development and review of
Medical Information
content (e.g., standard response letters, FAQs) to address unsolicited scientific inquiries from Healthcare Professionals (HCPs).
Provide
medical review and approval
for promotional and non-promotional materials developed by Marketing/Commercial teams to ensure
strict regulatory and compliance adherence
(e.g., FDA guidance for IVDs) in collaboration with Regulatory Affairs and Corporate Compliance.
Note all Medical Education and Communication materials must be fair-balanced and non-promotional scientific exchange.
4. Strategic and Regulatory Support
Contributes scientific insights to
Market Access/Reimbursement
strategies, especially regarding coverage policies (e.g., Medicare, Medicaid, VA, and commercial payers) and the appropriate interpretation of clinical utility data.
Work closely with
Regulatory and Quality Assurance
teams to support ongoing regulatory filings, post-market surveillance, and adherence to
IVD regulations
(e.g., FDA, ISO 13485, EU IVDR).
Participate in
Advisory Councils
with clinical experts to validate strategic assumptions and gather input on future product development pipeline applications of the IsoClear platform.
Qualifications/Requirements
Advanced clinical or scientific degree (MD, PharmD, RN, PhD)
in a life science discipline related to oncology (e.g., Oncology Diagnostics) is
required .
Minimum of
5 years of experience
in a Medical Affairs, Clinical Affairs, or Medical Science Liaison role within the
In Vitro Diagnostics (IVD) , Diagnostics, or Pharmaceutical industry.
Specific experience in Urologic Oncology,
liquid biopsy, or biomarker-based diagnostics is highly preferred.
Strong understanding of regulatory guidelines (FDA, CLIA, CAP, HIPAA), clinical research regulations/GCP, biostatistics, and standards for scientific exchange required.
Proficiency in Microsoft Office Suite
Excellent written and verbal communication skills
Strong attention to detail
Works well in a collaborative & team-oriented environment; good interpersonal skills
Ability to manage & prioritize workload effectively
Core Competencies
Scientific Acumen:
Ability to critically review, interpret, and communicate complex clinical study, basic science, and biostatistics data, especially related to protein structure analysis and proteomic/genomic cancer biomarkers.
Compliance:
Deep understanding of the
legal and regulatory landscape
governing medical communications and scientific exchange for IVD and IVDR products in the US (and internationally).
Communication:
Exceptional verbal, written, and presentation skills, with the ability to tailor technical content to diverse audiences (from scientists to commercial teams).
Travel:
Ability to travel domestically and occasionally internationally (estimated
50-70% ) for conferences, KOL meetings, and internal meetings.
Physical Requirements/ Working Conditions/Equipment Used:
Ability to sit, stand and/or walk throughout course of day; operate a computer and multitask across many software communication and data entry programs while operating and communicating through telephone device for several hours a day; ability to safely drive a vehicle and travel using appropriate and available mass and/or air transit. This position may require involvement outside of standard business hours. Offices reachable by elevator but should be able to climb stairs in case elevator out.
Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.
Cleveland Diagnostics offers an extremely robust benefits package which includes:
100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
100% Employer-paid Dental & Vision for entire family
No cost for employee coverage for Group Term Life, Short- & Long-Term Disability
4% retirement contribution Employer match
Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
Paid Family Leave Program
Generous PTO plan & holiday program
Flexible work schedule & lucrative employee referral program
Salary range may vary by work state/geographical region/territory
Easy to get to office location with newly built-out office space
Free coffee, snacks and other goodies all day long
Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.
Pay Range:
$85,000 - $150,000 per year
#J-18808-Ljbffr
Location:
Remote or Hybrid (Cleveland, Ohio)
Reports to:
VP Medical Affairs or Chief Medical Officer
Job Description:
The Medical Affairs Professional serves as a key scientific and clinical expert for Cleveland Diagnostics flagship IsoPSA product, a Class III In Vitro Diagnostic (IVD) assay for prostate cancer risk stratification. This role is responsible for driving the appropriate clinical utilization and scientific understanding of IsoPSA by engaging with Key Opinion Leaders (KOLs), generating real-world evidence, and ensuring accurate, compliant scientific communication across the organization and to the external medical community.
Essential Duties and Responsibilities
1. Scientific Exchange and Key Opinion Leader (KOL) Management
Establish and maintain relationships
with national and regional KOLs, investigators, and clinical societies (e.g., Urology, Oncology) to ensure a deep understanding of the scientific and clinical value of IsoPSA.
Serve as the
primary scientific resource
for external stakeholders, conducting
fair-balanced, evidence-based scientific exchange
on IsoPSA data, mechanism of action (IsoClear - Solvent Interaction Analysis (SIA) platform and methodology), and its role in the prostate cancer diagnostic pathway.
Gather and relay
clinical insights and unmet needs
from the field back to internal teams (e.g., R&D, Commercial, Regulatory Affairs, Clinical Operations) to inform product lifecycle planning, clinical strategy, and educational content.
2. Evidence Generation and Research Support
Support clinical research initiatives under the supervision of the Clinical Operations team by serving as a primary contact to investigators for investigator-initiated studies (IIS), facilitating internal review of IIS proposals for feasibility and conduct, identifying potential sites/investigators for sponsored trials, and assisting in site communications during active sponsored trials.
Support the
design and execution of Health Economics and Outcomes Research (HEOR)
studies to demonstrate the real-world value, clinical utility, and payer-access benefits of IsoPSA.
Contribute to the development of
clinical abstracts, posters, and manuscripts
for presentation at national and international medical conferences and publication in peer-reviewed journals.
3. Medical Education and Communication
Develop and deliver
training
on the scientific data and clinical use of IsoPSA for the Commercial, Market Access, Research & Development, and Clinical Operations teams.
Lead the development and review of
Medical Information
content (e.g., standard response letters, FAQs) to address unsolicited scientific inquiries from Healthcare Professionals (HCPs).
Provide
medical review and approval
for promotional and non-promotional materials developed by Marketing/Commercial teams to ensure
strict regulatory and compliance adherence
(e.g., FDA guidance for IVDs) in collaboration with Regulatory Affairs and Corporate Compliance.
Note all Medical Education and Communication materials must be fair-balanced and non-promotional scientific exchange.
4. Strategic and Regulatory Support
Contributes scientific insights to
Market Access/Reimbursement
strategies, especially regarding coverage policies (e.g., Medicare, Medicaid, VA, and commercial payers) and the appropriate interpretation of clinical utility data.
Work closely with
Regulatory and Quality Assurance
teams to support ongoing regulatory filings, post-market surveillance, and adherence to
IVD regulations
(e.g., FDA, ISO 13485, EU IVDR).
Participate in
Advisory Councils
with clinical experts to validate strategic assumptions and gather input on future product development pipeline applications of the IsoClear platform.
Qualifications/Requirements
Advanced clinical or scientific degree (MD, PharmD, RN, PhD)
in a life science discipline related to oncology (e.g., Oncology Diagnostics) is
required .
Minimum of
5 years of experience
in a Medical Affairs, Clinical Affairs, or Medical Science Liaison role within the
In Vitro Diagnostics (IVD) , Diagnostics, or Pharmaceutical industry.
Specific experience in Urologic Oncology,
liquid biopsy, or biomarker-based diagnostics is highly preferred.
Strong understanding of regulatory guidelines (FDA, CLIA, CAP, HIPAA), clinical research regulations/GCP, biostatistics, and standards for scientific exchange required.
Proficiency in Microsoft Office Suite
Excellent written and verbal communication skills
Strong attention to detail
Works well in a collaborative & team-oriented environment; good interpersonal skills
Ability to manage & prioritize workload effectively
Core Competencies
Scientific Acumen:
Ability to critically review, interpret, and communicate complex clinical study, basic science, and biostatistics data, especially related to protein structure analysis and proteomic/genomic cancer biomarkers.
Compliance:
Deep understanding of the
legal and regulatory landscape
governing medical communications and scientific exchange for IVD and IVDR products in the US (and internationally).
Communication:
Exceptional verbal, written, and presentation skills, with the ability to tailor technical content to diverse audiences (from scientists to commercial teams).
Travel:
Ability to travel domestically and occasionally internationally (estimated
50-70% ) for conferences, KOL meetings, and internal meetings.
Physical Requirements/ Working Conditions/Equipment Used:
Ability to sit, stand and/or walk throughout course of day; operate a computer and multitask across many software communication and data entry programs while operating and communicating through telephone device for several hours a day; ability to safely drive a vehicle and travel using appropriate and available mass and/or air transit. This position may require involvement outside of standard business hours. Offices reachable by elevator but should be able to climb stairs in case elevator out.
Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.
Cleveland Diagnostics offers an extremely robust benefits package which includes:
100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
100% Employer-paid Dental & Vision for entire family
No cost for employee coverage for Group Term Life, Short- & Long-Term Disability
4% retirement contribution Employer match
Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
Paid Family Leave Program
Generous PTO plan & holiday program
Flexible work schedule & lucrative employee referral program
Salary range may vary by work state/geographical region/territory
Easy to get to office location with newly built-out office space
Free coffee, snacks and other goodies all day long
Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.
Pay Range:
$85,000 - $150,000 per year
#J-18808-Ljbffr